Brain EdemaNCT04114799
Haemodynamical Optimization During Brain Surgery
A study testing Hemodynamic management based on invasive fluid responsiveness parameters and Hemodynamic management based on noninvasive cardiac output and SVV measurement in people with Brain Edema, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Edema
- What is being tested?
- Hemodynamic management based on invasive fluid responsiveness parameters and Hemodynamic management based on noninvasive cardiac output and SVV measurement
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Apr 2019to 30 Nov 2026
- 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
- Glasgow Coma scale 15
- ASA Physical Status Classification System I-III
- planed surgery for brain tumor to 5 hours
- postoperative awakening
- sinus rhythm
Who cannot join
- NYHA III, IV
- BMI over 40 in females and over 35 in men
- awake operation
- postoperative artificial ventilation
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
University Hospital Hradec Kralove
Hradec Králové, 50005
Pavel Dostal, MD, PhD, 00420495833218, pavel.dostal@fnhk.cz
Pavel Dostal, MD, PhD, 00420495832266, pavel.dostal@fnhk.cz
About this study
Official title: A Comparison of Perioperative Fluid Management Using Invasive Haemodynamical Measurement of Fluid Responsiveness (Aisys GE) and Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards) During Brain Surgery
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).
Read the detailed description
The aim of the study is to optimise fluid management and to reduce perioperative risks during brain surgery. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.
This study compares fluid management algorithms based either on invasive detection of fluid responsiveness using pulse pressure variation (PPV) and systolic pressure variation (SPV) values (Aisys GE monitoring system) in group A, or on noninvasive measurement of haemodynamics (stroke volume variation (SVV), cardiac index (CI) and systemic vascular resistance (SVR) values) (ClearSight, Edwards) in group B.
- Conditions
- Brain Edema
- Being tested
- Hemodynamic management based on invasive fluid responsiveness parameters, Hemodynamic management based on noninvasive cardiac output and SVV measurement
- Keywords
- fluid responsiveness, haemodynamical monitoring, ClearSight
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodynamic management based on invasive fluid responsiveness parametersProcedure or surgery
In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml/kg of Plasmalyte (Baxter)
Hemodynamic management based on noninvasive cardiac output and SVV measurementProcedure or surgery
In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used.
| Study group | Role | What they receive |
|---|---|---|
| Group A invasive haemodynamical measurement | Active comparator | No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml/kg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml/kg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness. Receives: Procedure: Hemodynamic management based on invasive fluid responsiveness parameters |
| Group B non-invasive haemodynamical measurement | Experimental | No continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards). Receives: Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid balance difference
the difference between fluid intake and output and losses during surgery will be calculated
Measured: up to 5 hours after start of operation
Secondary outcomes (4)
mean dose of norepinephrine
mean dose of norepinephrine will be calculated from total delivered dose devided by time of the surgery
Measured: up to 5 hours after start of operation
level of creatinin
plasma level of creatinin measured on the first postoperative day
Measured: 24 hours
postoperative lung dysfunction
postoperative lung dysfunction defined as SpO2 value less than 92% or oxygen therapy more than 6 hours postoperatively
Measured: 1 day
length of postoperative stay
number of days of stay in the hospital after the surgery
Measured: up to 2 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Apr 2019
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain EdemaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dostalova Vlasta, MD, PhD, University Hospital Hradec Kralove
- Investigators
- Pavel Dostal, MD, Ph.D., Study director, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114799
- Sponsor's protocol ID
- UHradec Kralove
- Status last verified
- May 2024
- First submitted
- 7 Sep 2019
- Last updated
- 10 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Perioperative Fluid Management Using Invasive Haemodynamical Measurement of Fluid Responsiveness (Aisys GE) and Non-invasive Measurement of Haemodynamics (ClearSight System, Edwards) During Brain Surgery
- ClinicalTrials.gov ID
- NCT04114799
- Acronym / sponsor ID
- UHradec Kralove
- Conditions
- Brain Edema
- Keywords
- fluid responsiveness, haemodynamical monitoring, ClearSight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 3 Oct 2019 (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.
The decision to give fluids perioperatively could be based on methods used to identify preload responsiveness, either invasive or noninvasive estimates of stroke volume variation during mechanical ventilation. This study compares fluid management using invasive measurement SPV/PPV (Aisys GE) and noninvasive haemodynamic measurement (ClarSight, Edwards).
Detailed description
The aim of the study is to optimise fluid management and to reduce perioperative risks during brain surgery. Adequate perioperative management guided by hemodynamic monitoring can help to reduce the risk of complications and thus potentially improve outcomes.
This study compares fluid management algorithms based either on invasive detection of fluid responsiveness using pulse pressure variation (PPV) and systolic pressure variation (SPV) values (Aisys GE monitoring system) in group A, or on noninvasive measurement of haemodynamics (stroke volume variation (SVV), cardiac index (CI) and systemic vascular resistance (SVR) values) (ClearSight, Edwards) in group B.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A invasive haemodynamical measurement | Active comparator | Procedure: Hemodynamic management based on invasive fluid responsiveness parametersNo continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid bolus will be applied in case of protocol defined hypotension according to the value of systolic pressure variation SPV (Aisys GE). The value of SPV (tidal volume 6 ml/kg) above 8% will be used to predict fluid responsiveness. In case of fluid responsiveness, bolus of 2ml/kg of Plasmalyte will be given within 10 minutes. Boluses will be repeated in hypotensive patients if fluid responsiveness persists. Norepinephrine will be used in hypotensive patients without predicted fluid responsiveness. |
| Group B non-invasive haemodynamical measurement | Experimental | Procedure: Hemodynamic management based on noninvasive cardiac output and SVV measurementNo continuous infusion of fluids will be used intraoperatively. A defined amount of fluid (20 ml of Plasmalyte, Baxter) will be used to flush the anesthetics and other drugs only. Fluid management and the use of norepinephrine will follow a protocol based on the values of cardiac index level, systemic vascular resistance and systolic volume variation (SVV) (ClearSight, Edwards). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Glasgow Coma scale 15
- ASA Physical Status Classification System I-III
- planed surgery for brain tumor to 5 hours
- postoperative awakening
- sinus rhythm
Key exclusion criteria (4 listed)
- NYHA III, IV
- BMI over 40 in females and over 35 in men
- awake operation
- postoperative artificial ventilation
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 |
|---|---|---|
| Hemodynamic management based on invasive fluid responsiveness parametersIn case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml/kg of Plasmalyte (Baxter) | Procedure or surgery | Group A invasive haemodynamical measurement |
| Hemodynamic management based on noninvasive cardiac output and SVV measurementIn case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used. | Procedure or surgery | Group B non-invasive haemodynamical measurement |
Primary outcome
fluid balance difference
Time frame: up to 5 hours after start of operation
the difference between fluid intake and output and losses during surgery will be calculated
4 secondary outcomes
mean dose of norepinephrine
Time frame: up to 5 hours after start of operation
level of creatinin
Time frame: 24 hours
postoperative lung dysfunction
Time frame: 1 day
length of postoperative stay
Time frame: up to 2 month after surgery
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 10 May 2024.
Related trials for Brain Edema
Not yet recruitingObservational study
Decompressive Craniectomy After Aneurysmal Subarachnoid Hemorrhage (DECIDE-SAH)
Aneurysmal Subarachnoid Hemorrhage
Not yet recruiting
Modulating Inflammation in Neuro-Trauma
Traumatic Brain Injury
Not yet recruitingPhase 2
Early Prophylactic Versus Late Salvage Recombinant Human Endostatin in Managing Radiosurgery-Induced Brain Injury for NSCLC Brain Metastases
Lung Cancer (Non-Small Cell), Radiation
RecruitingObservational study
Chinese Multicenter Cohort Study of Intracerebral Hemorrhage
Intracerebral Hemorrhage
Not yet recruitingObservational study
Transcranial Doppler Evaluation After Endovascular Thrombectomy for Acute Ischemic Stroke (PRECISE-TCD)
Anterior Cerebral Artery Syndrome, Anterior Cerebral Artery Stroke
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.
Pavel Dostal, MD, Ph.D. study director
University Hospital Hradec Kralove
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodynamic management based on invasive fluid responsiveness parameters and Hemodynamic management based on noninvasive cardiac output and SVV measurement in people with Brain Edema, run by University Hospital Hradec Kralove 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 5 inclusion and 4 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 10 May 2024. 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 Vlasta Dostálová, MD, Ph.D. (777883571, dostavla@seznam.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fluid balance difference (time frame: up to 5 hours after start of operation). 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 10 May 2024.