Surgery ComplicationsNCHGDTNCT07101991
Effects of GDHT (Goal Directed Hemodynamic Therapy) Using a Non-invasive Hemodynamic Monitoring in Elective Neurosurgery
A study testing Standard monitoring and Goal-Directed Therapy in people with Surgery Complications, run by Brno University Hospital at 1 site in Czechia.
Trial summary
This study aims to assess the safety and efficacy of GDHT using the non-invasive Starling™ SV System in elective neurosurgery. The tested group of patients (n=70) will be compared with a control group (n=70), where hemodynamic management will be guided by standard vital signs monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery Complications
- What is being tested?
- Standard monitoring and Goal-Directed Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be eligible for the trial if they meet all of the following criteria:
- Age ≥ 18 years
- Elective brain surgery with an expected duration ≥ 2 h
- Category 1-3 according to the ASA (American Society of Anesthesiologists) Physical Status Classification
- Lateral or supine operative position
- Signed the relevant informed consent form
Who cannot join
- Subjects will not be eligible for the trial if they meet any of the following criteria:
- Category 4 according to the ASA Physical Status Classification
- Surgery for traumatic brain injury or acute hemorrhagic stroke
- Awake brain surgery
- Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards)
- Unavailability of hemodynamic monitoring data
Show all 9Show fewer
- Cardiac arrhythmia with irregular cardiac rhythm
- Known hypersensitivity to the active substance or to any of the excipients of IMP (Investigational Medicinal Product)
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
The University Hospital Brno
Brno, 62500
Veronika Kočí, M.D., +420532233850, koci.veronika@fnbrno.cz
Ondřej Hrdý, M.D., Ph.D., +420532233850, hrdy.ondrej@fnbrno.cz
About this study
Official title: Effects of Goal-directed Fluid Management Guided by a Non-invasive Device on the Incidence of Postoperative Complications in Neurosurgery: a Multicenter, Prospective, Randomized, Controlled Study
This study aims to assess the safety and efficacy of GDHT using the non-invasive Starling™ SV System in elective neurosurgery. The tested group of patients (n=70) will be compared with a control group (n=70), where hemodynamic management will be guided by standard vital signs monitoring.
Read the detailed description
Patients undergoing major surgery are at risk for inadequate intravascular volumes and therefore inadequate tissue perfusion and oxygen delivery. Especially in neurosurgery, fluid management can be a challenge. In many surgical areas, such as orthopedics, gynecology or abdominal surgery, goal-directed fluid therapy is used with the aim of reducing postoperative complications. Current knowledge regarding effect of the goal-directed therapy in neurosurgery is limited.
This is a multicenter, prospective, randomized, controlled study that compares two approaches to fluid management in elective brain surgery. Patients scheduled for brain surgery will be screened whether they meet the inclusion criteria and after obtaining informed consent, the patient will be randomized to one of two study arms.
In the first (standard) arm standard vital signs monitoring will be used during the surgery and perioperative fluid management and administration of vasopressors will be guided by the decision of the attending anaesthetist.
In the second (GDT) arm perioperative fluid management and administration of vasopressors will be guided by a non-invasive hemodynamic monitor STARLINK™SV, which will be introduced in addition to standard monitoring.
The primary outcome is the incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups and their comparison. The secondary outcome is to investigate the efficacy and additional safety parameters of GDHT guided by non-invasive advanced hemodynamic monitoring versus hemodynamic management guided by standard vital signs monitoring.
This study will enroll 140 patients in total, 70 in each group. After completion of enrolment of patients the statistical analysis will be performed.
- Conditions
- Surgery Complications
- Being tested
- Standard monitoring, Goal-Directed Therapy
- Keywords
- neurosurgery, goal-directed therapy, adverse events
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard monitoringOther
Administration of fluids and vasoactive drugs guided by standard vital signs monitoring
Goal-Directed TherapyOther
Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring
| Study group | Role | What they receive |
|---|---|---|
| Standard monitoring | Active comparator | In this arm standard monitoring of vital signs will be used during operation. Receives: Other: Standard monitoring |
| Goal-Directed Therapy | Experimental | A non-invasive hemodynamic monitor STARLINK™SV will be used in addition to standard monitoring. Receives: Other: Goal-Directed Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with acute kidney Injury
Defined according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Stage 1: serum creatinine 1.5-1.9 times baseline value within 7 days or ≥27 µmol l-1 (0.3 mg dl-1) increase within 48 h; urine output ≤0.5 ml kg-1 h-1 for 6-12 h Stage 2: serum creatinine 2.0-2.9 times baseline value within 7 days; urine output ≤0.5 ml kg-1 h-1 for 12 h Stage 3: serum creatinine 3.0 times baseline within 7 days or increase in serum creatinine to ≥354 µmol l-1 (≥4.0 mg.dl1 with an acute rise of > 44 mmol l-1 (0.5 mg/dl-1) or initiation of renal replacement therapy or in patients < 18 years, decrease in eGFR (estimated Glomerular Filtration Rate) to < 35 ml min-1 per 1.73m2; urine output ≤0.3 ml kg1 h-1 for 24 h or anuria for 12 h.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with acute Respiratory Distress Syndrome (ARDS)
The Berlin definition of Respiratory Distress Syndrome:
Timing: Within one week of a known clinical insult or new or worsening respiratory symptoms and Chest imaging: Bilateral opacities not fully explained by effusions, lobar/lung collapse or nobles and Origin of oedema: Respiratory failure not fully explained by cardiac failure or fluid overload.
Need objective assessment (e.g. echocardiography) to exclude hydrostatic oedema if no risk factor is presented and Oxygenation disorder: mild: PaO2 (partial pressure of oxygen in arterial blood):FIO2 (Fraction of Inspired Oxygen) between 26.7 and 40.0 kPa (kilopascal) (200-300mmHg) with PEEP (Positive End-Expiratory Pressure) or CPAP (Continuous Positive Airway Pressure) ≥5 cmH2O (centimeters of water). Moderate: PaO2:FIO2 between 13.3 and 26.6 kPa (100- 200 mmHg) with PEEP ≥5 cmH2O. Severe: PaO2:FIO2 ≤13.3 kPa (100mmHg) with PEEP ≥5 cmH2O.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with arrhythmia
Defined as electrocardiograph (ECG) evidence of cardiac rhythm disturbance. AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with cardiac arrest
Cessation of cardiac mechanical activity, as confirmed by the absence of signs of circulation. AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with cardiogenic pulmonary oedema
Defined as evidence of fluid accumulation in the alveoli due to poor cardiac function.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with deep vein thrombosis (DVT)
A new blood clot or thrombus within the venous system. Appropriate diagnostic tests include ultrasound, venography, CT or MRI venography. Plasma D-dimer measurement is not recommended as a diagnostic test in the first three weeks following surgery.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with pulmonary embolism (PE)
A new blood clot or thrombus within the pulmonary arterial system. AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with gastrointestinal bleed
Clinical or endoscopic evidence of blood in the gastrointestinal tract. AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with infection, source uncertain
Infection where there is strong clinical suspicion of infection but the source has not been confirmed because clinical information suggests more than one possible site, meeting two or more of the following criteria: core temperature < 36°C or >38°C; white cell count >12×109 l-1 or < 4×109 l-1, respiratory rate >20 breaths per minute or PaCO2 < 4.7 kPa (35mmHg); pulse rate >90 beats per minute.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with laboratory confirmed bloodstream infection
Infection which meets at least one of the following criteria which should not be related to infection at another site:
- Patient has a recognised pathogen cultured from one or more blood cultures and the organism cultured from blood is not related to an infection at another site.
- Patient has at least one of the following signs or symptoms: fever >38°C, chills or hypotension, and at least one of the following.
- Common skin contaminant cultured from two or more blood cultures drawn on separate occasions.
- Common skin contaminant cultured from at least one blood culture from a patient with an intravascular line, and the physician institutes appropriate antimicrobial therapy.
- Positive blood antigen test. AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with myocardial infarction
Defined as increase in serum cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and at least one of the following criteria: symptoms of ischaemia; new or presumed new significant ST segment or T wave ECG changes or new left bundle branch block; development of pathological Q waves on ECG; radiological or echocardiographic evidence of new loss of viable myocardium or new regional wall motion abnormality; identification of an intracoronary thrombus at angiography or autopsy.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with pneumonia
Definition: Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease):
- new or progressive and persistent infiltrates
- consolidation
- cavitation; at least one of the following: (1) fever (>38°C) with no other recognised cause (2) leucopaenia (white cell count < 4 × 109 l-1) or leucocytosis (white cell count >12 × 109 l-1) (3) for adults >70 years old, altered mental status with no other recognised cause; and at least two of the following:
- new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements
- new onset or worsening cough, or dyspnoea, or tachypnoea
- rales or bronchial breath sounds
- worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand).
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with paralytic ileus
Failure to tolerate solid food or defecate for three or more days after surgery.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with postoperative haemorrhage
Blood loss within 72 h after the start of surgery which would normally result in transfusion of blood.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with stroke
An embolic, thrombotic or haemorrhagic cerebral event with persistent residual motor, sensory or cognitive dysfunction (e.g. hemiplegia, hemiparesis, aphasia, sensory deficit, impaired memory).
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with brain oedema
Brain oedema confirmed on CT or MRI scan. AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with surgical site infection (superficial)
A superficial incisional surgical site infection is defined as one which meets the following criteria:
- Infection occurs within 30 days after surgery and
- Involves only skin and subcutaneous tissue of the incision and
- The patient has at least one of the following:
- purulent drainage from the superficial incision
- organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision
- at least one of the following symptoms or signs of infection: pain or tenderness, localised swelling, redness or heat, and superficial incision is deliberately opened by surgeon and is culture positive or not cultured. A culture-negative finding does not meet this criterion.
- diagnosis of an incisional surgical site infection by a surgeon or attending physician.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with surgical site infection (deep)
- Infection occurs within 30 days after surgery if no implant is left in place or 1 year if implant is in place.
- Involves deep soft tissues (e.g. fascial and muscle layers) of the incision.
- The patient has at least one of the following:
- purulent drainage from the deep incision but not from the organ/space component of the surgical site
- a deep incision spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured when the patient has at least one of the following symptoms or signs: fever (>38°C), or localised pain or tenderness. A culture- negative finding does not meet this criterion.
- an abscess or other evidence of infection involving the deep incision is found on direct examination, during surgery, or by histopathological or radiological examination
- diagnosis of an incisional surgical site infection by a surgeon or attending physician.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with surgical site infection (organ/space)
Infection which involves any part of the body excluding the fascia or muscle layers and meets the following criteria:
- Infection occurs within 30 days after surgery.
- The infection appears to be related to the surgical procedure and involves any part of the body, excluding the skin incision, fascia or muscle layers opened or manipulated during the operative procedure.
- The patient has at least one of the following:
- purulent drainage from a drain that is placed through a stab wound into the organ/space
- organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space
- an abscess or other evidence of infection involving the organ/space that is found on direct examination, during reoperation or by histopathological or radiological examination
- diagnosis of an organ/space surgical site infection by a surgeon or attending physician. AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Number of participants with urinary tract infection
A positive urine culture of ≥105 colony forming units ml-1 with no more than two species of micro-organisms, and with at least one of the following symptoms or signs: fever (>38°C), urgency, frequency, dysuria, suprapubic tenderness, costovertebral angle pain or tenderness with no other recognised cause. Each of these criteria should be identified within a 24-h period.
AESI will be analysed descriptively and compared between study groups.
Measured: 28 days
Secondary outcomes (18)
Duration of surgery
Duration of surgery (min) - will be analysed descriptively and compared between study arms
Measured: During the surgery (hours)
Length of hospital stay
LOS (Length of stay, day of admission - day of discharge will be counted as 1 day) - will be calculated as a number of days between admission and discharge, analysed descriptively and compared between study groups.
Measured: Days (up to 28)
ICU length of stay
ICU LOS (day of admission - day of discharge will be counted as 1 day) - will be calculated as a number of days between admission to the ICU and discharge from the ICU, analysed descriptively and compared between study groups.
Measured: Days (up to 28)
28-day mortality
28-day mortality (number of patients who are not alive 28 days after randomization) will be evaluated as a number and percentage of patients who are not alive 28 days after randomization and compared between study arms.
Measured: 28 days after randomization
Adverse events
Descriptive analysis of the incidence of any adverse events and reactions
Measured: 28 days
Hemodynamic characteristics - MAP (Mean arterial pressure)
MAP (mmHg; before, after surgery) will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Hemodynamic characteristics - HR (Heart rate)
HR (Bpm; before, after surgery) will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Hemodynamic characteristics - SVV (Stroke volume variation) measured by The Starling™ SV System
SVV (%; before, after surgery will be analysed descriptively and compared between study arms.
Measured: During the surgery (hours)
Hemodynamic characteristics - number of episodes of hypotension
Number of episodes of hypotension will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Hemodynamic characteristics - number of vasopressor administrations
Number of vasopressor administrations will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Hemoglobin
Hemoglobin (g/l; before, after surgery and 24 hours after surgery) - will be analysed descriptively and compared between study arms.
Measured: 24 hours
Plasma lactate level
Plasma lactate level (mmol/L; before, after surgery and 24 hours after surgery) will be analysed descriptively and compared between study arms.
Measured: 24 hours
Volume of blood loss
Volume of blood loss (ml/kg; during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Urinary output
Urinary output (ml/kg/hod; during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Number of administered units of packed RBC (Red blood cell)
Number of administered units of packed RBC (during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Number of subjects receiving transfusion
Number of subjects receiving transfusion (during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Crystalloid and colloid solutions consumption
Crystalloid and colloid solutions consumption (type and total volume of infusion during surgery and in the 24-hour postoperative period) will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Boluses of crystalloids
Boluses of crystalloids (ml; during surgery) will be analysed descriptively and compared between study arms.
Measured: During the surgery and 24 hours post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start1 Dec 2025
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague, Zlin Regional Hospital
- Responsible party
- Principal investigator, Roman Gal, Brno University Hospital
- Investigators
- Veronika Kočí, M.D., Study chair, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101991
- Sponsor's protocol ID
- CT0012025
- Acronym
- NCHGDT
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Goal-directed Fluid Management Guided by a Non-invasive Device on the Incidence of Postoperative Complications in Neurosurgery: a Multicenter, Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT07101991
- Acronym / sponsor ID
- NCHGDT / CT0012025
- Conditions
- Surgery Complications
- Keywords
- neurosurgery, goal-directed therapy, adverse events
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague, Zlin Regional Hospital
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the safety and efficacy of GDHT using the non-invasive Starling™ SV System in elective neurosurgery. The tested group of patients (n=70) will be compared with a control group (n=70), where hemodynamic management will be guided by standard vital signs monitoring.
Detailed description
Patients undergoing major surgery are at risk for inadequate intravascular volumes and therefore inadequate tissue perfusion and oxygen delivery. Especially in neurosurgery, fluid management can be a challenge. In many surgical areas, such as orthopedics, gynecology or abdominal surgery, goal-directed fluid therapy is used with the aim of reducing postoperative complications. Current knowledge regarding effect of the goal-directed therapy in neurosurgery is limited.
This is a multicenter, prospective, randomized, controlled study that compares two approaches to fluid management in elective brain surgery. Patients scheduled for brain surgery will be screened whether they meet the inclusion criteria and after obtaining informed consent, the patient will be randomized to one of two study arms.
In the first (standard) arm standard vital signs monitoring will be used during the surgery and perioperative fluid management and administration of vasopressors will be guided by the decision of the attending anaesthetist.
In the second (GDT) arm perioperative fluid management and administration of vasopressors will be guided by a non-invasive hemodynamic monitor STARLINK™SV, which will be introduced in addition to standard monitoring.
The primary outcome is the incidence of adverse events and reactions according to following Adverse Events of Special Interest (AESI) in both study groups and their comparison. The secondary outcome is to investigate the efficacy and additional safety parameters of GDHT guided by non-invasive advanced hemodynamic monitoring versus hemodynamic management guided by standard vital signs monitoring.
This study will enroll 140 patients in total, 70 in each group. After completion of enrolment of patients the statistical analysis will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Standard monitoring | Active comparator | Other: Standard monitoringIn this arm standard monitoring of vital signs will be used during operation. |
| Goal-Directed Therapy | Experimental | Other: Goal-Directed TherapyA non-invasive hemodynamic monitor STARLINK™SV will be used in addition to standard monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Elective brain surgery with an expected duration ≥ 2 h
- Category 1-3 according to the ASA (American Society of Anesthesiologists) Physical Status Classification
- Lateral or supine operative position
- Signed the relevant informed consent form
Key exclusion criteria (9 listed)
- Category 4 according to the ASA Physical Status Classification
- Surgery for traumatic brain injury or acute hemorrhagic stroke
- Awake brain surgery
- Osmotherapy before surgery (with the exception of prophylactic administration of osmotic agents according to institutional standards)
- Unavailability of hemodynamic monitoring data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard monitoringAdministration of fluids and vasoactive drugs guided by standard vital signs monitoring | Other | Standard monitoring |
| Goal-Directed TherapyAdministration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring | Other | Goal-Directed Therapy |
Primary outcome
Number of participants with acute kidney Injury
Time frame: 28 days
Defined according to Kidney Disease Improving Global Outcomes (KDIGO) guidelines: Stage 1: serum creatinine 1.5-1.9 times baseline value within 7 days or ≥27 µmol l-1 (0.3 mg dl-1) increase within 48 h; urine output ≤0.5 ml kg-1 h-1 for 6-12 h Stage 2: serum creatinine 2.0-2.9 times baseline value within 7 days; urine output ≤0.5 ml kg-1 h-1 for 12 h Stage 3: serum creatinine 3.0 times baseline within 7 days or increase in serum creatinine to ≥354 µmol l-1 (≥4.0 mg.dl1 with an acute rise of > 44 mmol l-1 (0.5 mg/dl-1) or initiation of renal replacement therapy or in patients < 18 years, decrease in eGFR (estimated Glomerular Filtration Rate) to < 35 ml min-1 per 1.73m2; urine output ≤0.3 ml kg1 h-1 for 24 h or anuria for 12 h. AESI will be analysed descriptively and compared between study groups.
Number of participants with acute Respiratory Distress Syndrome (ARDS)
Time frame: 28 days
The Berlin definition of Respiratory Distress Syndrome: Timing: Within one week of a known clinical insult or new or worsening respiratory symptoms and Chest imaging: Bilateral opacities not fully explained by effusions, lobar/lung collapse or nobles and Origin of oedema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic oedema if no risk factor is presented and Oxygenation disorder: mild: PaO2 (partial pressure of oxygen in arterial blood):FIO2 (Fraction of Inspired Oxygen) between 26.7 and 40.0 kPa (kilopascal) (200-300mmHg) with PEEP (Positive End-Expiratory Pressure) or CPAP (Continuous Positive Airway Pressure) ≥5 cmH2O (centimeters of water). Moderate: PaO2:FIO2 between 13.3 and 26.6 kPa (100- 200 mmHg) with PEEP ≥5 cmH2O. Severe: PaO2:FIO2 ≤13.3 kPa (100mmHg) with PEEP ≥5 cmH2O. AESI will be analysed descriptively and compared between study groups.
Number of participants with arrhythmia
Time frame: 28 days
Defined as electrocardiograph (ECG) evidence of cardiac rhythm disturbance. AESI will be analysed descriptively and compared between study groups.
Number of participants with cardiac arrest
Time frame: 28 days
Cessation of cardiac mechanical activity, as confirmed by the absence of signs of circulation. AESI will be analysed descriptively and compared between study groups.
Number of participants with cardiogenic pulmonary oedema
Time frame: 28 days
Defined as evidence of fluid accumulation in the alveoli due to poor cardiac function. AESI will be analysed descriptively and compared between study groups.
Number of participants with deep vein thrombosis (DVT)
Time frame: 28 days
A new blood clot or thrombus within the venous system. Appropriate diagnostic tests include ultrasound, venography, CT or MRI venography. Plasma D-dimer measurement is not recommended as a diagnostic test in the first three weeks following surgery. AESI will be analysed descriptively and compared between study groups.
Number of participants with pulmonary embolism (PE)
Time frame: 28 days
A new blood clot or thrombus within the pulmonary arterial system. AESI will be analysed descriptively and compared between study groups.
Number of participants with gastrointestinal bleed
Time frame: 28 days
Clinical or endoscopic evidence of blood in the gastrointestinal tract. AESI will be analysed descriptively and compared between study groups.
Number of participants with infection, source uncertain
Time frame: 28 days
Infection where there is strong clinical suspicion of infection but the source has not been confirmed because clinical information suggests more than one possible site, meeting two or more of the following criteria: core temperature < 36°C or >38°C; white cell count >12×109 l-1 or < 4×109 l-1, respiratory rate >20 breaths per minute or PaCO2 < 4.7 kPa (35mmHg); pulse rate >90 beats per minute. AESI will be analysed descriptively and compared between study groups.
Number of participants with laboratory confirmed bloodstream infection
Time frame: 28 days
Infection which meets at least one of the following criteria which should not be related to infection at another site: 1. Patient has a recognised pathogen cultured from one or more blood cultures and the organism cultured from blood is not related to an infection at another site. 2. Patient has at least one of the following signs or symptoms: fever >38°C, chills or hypotension, and at least one of the following. 1. Common skin contaminant cultured from two or more blood cultures drawn on separate occasions. 2. Common skin contaminant cultured from at least one blood culture from a patient with an intravascular line, and the physician institutes appropriate antimicrobial therapy. 3. Positive blood antigen test. AESI will be analysed descriptively and compared between study groups.
Number of participants with myocardial infarction
Time frame: 28 days
Defined as increase in serum cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and at least one of the following criteria: symptoms of ischaemia; new or presumed new significant ST segment or T wave ECG changes or new left bundle branch block; development of pathological Q waves on ECG; radiological or echocardiographic evidence of new loss of viable myocardium or new regional wall motion abnormality; identification of an intracoronary thrombus at angiography or autopsy. AESI will be analysed descriptively and compared between study groups.
Number of participants with pneumonia
Time frame: 28 days
Definition: Two or more serial chest radiographs with at least one of the following (one radiograph is sufficient for patients with no underlying pulmonary or cardiac disease): 1. new or progressive and persistent infiltrates 2. consolidation 3. cavitation; at least one of the following: (1) fever (>38°C) with no other recognised cause (2) leucopaenia (white cell count < 4 × 109 l-1) or leucocytosis (white cell count >12 × 109 l-1) (3) for adults >70 years old, altered mental status with no other recognised cause; and at least two of the following: 1. new onset of purulent sputum or change in character of sputum, or increased respiratory secretions, or increased suctioning requirements 2. new onset or worsening cough, or dyspnoea, or tachypnoea 3. rales or bronchial breath sounds 4. worsening gas exchange (hypoxaemia, increased oxygen requirement, increased ventilator demand). AESI will be analysed descriptively and compared between study groups.
Number of participants with paralytic ileus
Time frame: 28 days
Failure to tolerate solid food or defecate for three or more days after surgery. AESI will be analysed descriptively and compared between study groups.
Number of participants with postoperative haemorrhage
Time frame: 28 days
Blood loss within 72 h after the start of surgery which would normally result in transfusion of blood. AESI will be analysed descriptively and compared between study groups.
Number of participants with stroke
Time frame: 28 days
An embolic, thrombotic or haemorrhagic cerebral event with persistent residual motor, sensory or cognitive dysfunction (e.g. hemiplegia, hemiparesis, aphasia, sensory deficit, impaired memory). AESI will be analysed descriptively and compared between study groups.
Number of participants with brain oedema
Time frame: 28 days
Brain oedema confirmed on CT or MRI scan. AESI will be analysed descriptively and compared between study groups.
Number of participants with surgical site infection (superficial)
Time frame: 28 days
A superficial incisional surgical site infection is defined as one which meets the following criteria: 1. Infection occurs within 30 days after surgery and 2. Involves only skin and subcutaneous tissue of the incision and 3. The patient has at least one of the following: 1. purulent drainage from the superficial incision 2. organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision 3. at least one of the following symptoms or signs of infection: pain or tenderness, localised swelling, redness or heat, and superficial incision is deliberately opened by surgeon and is culture positive or not cultured. A culture-negative finding does not meet this criterion. 4. diagnosis of an incisional surgical site infection by a surgeon or attending physician. AESI will be analysed descriptively and compared between study groups.
Number of participants with surgical site infection (deep)
Time frame: 28 days
1. Infection occurs within 30 days after surgery if no implant is left in place or 1 year if implant is in place. 2. Involves deep soft tissues (e.g. fascial and muscle layers) of the incision. 3. The patient has at least one of the following: 1. purulent drainage from the deep incision but not from the organ/space component of the surgical site 2. a deep incision spontaneously dehisces or is deliberately opened by a surgeon and is culture-positive or not cultured when the patient has at least one of the following symptoms or signs: fever (>38°C), or localised pain or tenderness. A culture- negative finding does not meet this criterion. 3. an abscess or other evidence of infection involving the deep incision is found on direct examination, during surgery, or by histopathological or radiological examination 4. diagnosis of an incisional surgical site infection by a surgeon or attending physician. AESI will be analysed descriptively and compared between study groups.
Number of participants with surgical site infection (organ/space)
Time frame: 28 days
Infection which involves any part of the body excluding the fascia or muscle layers and meets the following criteria: 1. Infection occurs within 30 days after surgery. 2. The infection appears to be related to the surgical procedure and involves any part of the body, excluding the skin incision, fascia or muscle layers opened or manipulated during the operative procedure. 3. The patient has at least one of the following: 1. purulent drainage from a drain that is placed through a stab wound into the organ/space 2. organisms isolated from an aseptically obtained culture of fluid or tissue in the organ/space 3. an abscess or other evidence of infection involving the organ/space that is found on direct examination, during reoperation or by histopathological or radiological examination 4. diagnosis of an organ/space surgical site infection by a surgeon or attending physician. AESI will be analysed descriptively and compared between study groups.
Number of participants with urinary tract infection
Time frame: 28 days
A positive urine culture of ≥105 colony forming units ml-1 with no more than two species of micro-organisms, and with at least one of the following symptoms or signs: fever (>38°C), urgency, frequency, dysuria, suprapubic tenderness, costovertebral angle pain or tenderness with no other recognised cause. Each of these criteria should be identified within a 24-h period. AESI will be analysed descriptively and compared between study groups.
18 secondary outcomes
Duration of surgery
Time frame: During the surgery (hours)
Length of hospital stay
Time frame: Days (up to 28)
ICU length of stay
Time frame: Days (up to 28)
28-day mortality
Time frame: 28 days after randomization
Adverse events
Time frame: 28 days
Hemodynamic characteristics - MAP (Mean arterial pressure)
Time frame: During the surgery and 24 hours post operation
Hemodynamic characteristics - HR (Heart rate)
Time frame: During the surgery and 24 hours post operation
Hemodynamic characteristics - SVV (Stroke volume variation) measured by The Starling™ SV System
Time frame: During the surgery (hours)
Hemodynamic characteristics - number of episodes of hypotension
Time frame: During the surgery and 24 hours post operation
Hemodynamic characteristics - number of vasopressor administrations
Time frame: During the surgery and 24 hours post operation
Hemoglobin
Time frame: 24 hours
Plasma lactate level
Time frame: 24 hours
Volume of blood loss
Time frame: During the surgery and 24 hours post operation
Urinary output
Time frame: During the surgery and 24 hours post operation
Number of administered units of packed RBC (Red blood cell)
Time frame: During the surgery and 24 hours post operation
Number of subjects receiving transfusion
Time frame: During the surgery and 24 hours post operation
Crystalloid and colloid solutions consumption
Time frame: During the surgery and 24 hours post operation
Boluses of crystalloids
Time frame: During the surgery and 24 hours post operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Veronika Kočí, M.D. study chair
Brno University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard monitoring and Goal-Directed Therapy in people with Surgery Complications, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roman Gál, prof. (+420 532 233 850, gal.roman@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with acute kidney Injury (time frame: 28 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.