Surgery--ComplicationsNCT04754295
Goal-directed Therapy in Neurosurgery.
A study testing Goal-Directed Therapy and STANDARD in people with Surgery--Complications, run by Brno University Hospital at 1 site in Czechia.
Trial summary
The purpose of the study is to assess feasibility of future large randomised controled study aimed on assessment of effect of goal-directed therapy on incidence of complications in neurosurgery compared to standard care. 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?
- Goal-Directed Therapy and STANDARD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- age at least 18 years
- anticipated duration of surgery at least 2 hours
- signed written consent form
- American Society of Anesthesiologists (ASA) classification < 4.
Who cannot join
- unavailability of hemodynamic monitor
- emergency operation
- ASA ≥4
- sitting operating position and awake craniotomy
- awake craniotomy
- serious cardiorespiratory disorder
- cardiac arrythmia
- obesity with BMI above 35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Goal-directed Fluid Management Guided by Non-invasive Device on Incidence of Postoperative Complications in Neurosurgery: Pilot Study
The purpose of the study is to assess feasibility of future large randomised controled study aimed on assessment of effect of goal-directed therapy on incidence of complications in neurosurgery compared to standard care.
Read the detailed description
Patients undergoing neurosurgical operations are at risk of inadequate intravascular volume for several reasons. The appropriate fluid management in neurosurgery is a challenge. Goal-directed therapy has been shown to improve the outcome of patients undergoing major surgery. Current knowledge regarding effect of fluid management on patient-orientated outcomes in neurosurgery is limited.
This study is designed as a pilot study with two parallel groups. Patients scheduled to planned brain surgery at the University Hospital Brno will be screened whether they meet the inclusion criteria. After obtaining informed consent, the patient will be randomized to one of the study arms.
In one arm (STANDARD) standard monitoring of vital signs will be introduced. During the operation, perioperative fluid therapy and administration of vasoactive agents will depend entirely at the discretion of the attending anaesthetist. Postoperative therapy will be fully controlled and will depend on the decision of the attending physician. In the second arm (GDT), a non-invasive hemodynamic monitor STARLINK™SV will be introduced in addition to standard monitoring. In this arm, basal infusion with crystalloid balanced solution will be initiated. Additional boluses of fluids will be administered based on haemodynamic monitoring. The primary outcome of the study is a proportion of patients with serious adverse event (SAE). Incidence of SAEs will be compared between study groups. SAE will be defined as unsatisfactory brain tissue relaxation at the end of operation and any intervention for brain oedema postoperatively.
The secondary outcome is to compare proportion of patients with postoperative complications in both groups and length of ICU and hospital stay.
This study will enroll 34 patients in total, 17 in each group. After completion of enrolment of patients the statistical analysis will be performed.
- Conditions
- Surgery--Complications
- Being tested
- Goal-Directed Therapy, STANDARD
- Keywords
- Neurosurgery, Goal-Directed Therapy, Complications, Pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Directed TherapyOther
Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring
STANDARDOther
Administration of fluids and vasoactive drugs guided by standard vital signs monitoring
| Study group | Role | What they receive |
|---|---|---|
| STANDARD | Experimental | In this arm standard monitoring of vital signs will be used during operation. Receives: Other: STANDARD |
| GDT | 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.
Serious Adverse Events 1
Assessment of number of patients with serious adverse event (SAE). SAE is defined as unsatisfactory brain tissue relaxation at the end of surgery assessed by neurosurgeon. Level 3 or 4 of brain tissue relaxation will be considered as unsatisfactory (level 1 - completely relaxed, level 2 - satisfactorily relaxed, level 3 - firm, level 4 - bulging).
Measured: During the Surgery
Serious Adverse Events 2
Assessment of number of patients with serious adverse event (SAE). SAE is defined as any intervention indicated for treatment of brain edema 24 hours after surgery.
Measured: 24 hours postoperatively
Recruitment rate
Proportion of eligible patients who consent to participate in the study.
Measured: through study completion, an average of 6 months
Completeness of Case Report Forms
Proportion of enrolled patients with completed Case Report Form.
Measured: through study completion, an average of 6 months
Secondary outcomes (1)
Complications
Number of patients with pre-defined postoperative complication.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Oct 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ondrej Hrdy, Brno University Hospital
- Investigators
- Roman Gal, M.D., Ph.D., Principal investigator, Masaryk University Brno and University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754295
- Sponsor's protocol ID
- CT0012021
- Status last verified
- May 2022
- First submitted
- 2 Feb 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hrdy O, Duba M, Dolezelova A, Roskova I, Hlavaty M, Traj R, Bonisch V, Smrcka M, Gal R. Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a pilot and feasibility randomized controlled trial. Perioper Med (Lond). 2023 Jul 5;12(1):32. doi: 10.1186/s13741-023-00321-3.
PubMed 37408018
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Goal-directed Fluid Management Guided by Non-invasive Device on Incidence of Postoperative Complications in Neurosurgery: Pilot Study
- ClinicalTrials.gov ID
- NCT04754295
- Acronym / sponsor ID
- CT0012021
- Conditions
- Surgery--Complications
- Keywords
- Neurosurgery, Goal-Directed Therapy, Complications, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 15 Feb 2021 (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 purpose of the study is to assess feasibility of future large randomised controled study aimed on assessment of effect of goal-directed therapy on incidence of complications in neurosurgery compared to standard care.
Detailed description
Patients undergoing neurosurgical operations are at risk of inadequate intravascular volume for several reasons. The appropriate fluid management in neurosurgery is a challenge. Goal-directed therapy has been shown to improve the outcome of patients undergoing major surgery. Current knowledge regarding effect of fluid management on patient-orientated outcomes in neurosurgery is limited.
This study is designed as a pilot study with two parallel groups. Patients scheduled to planned brain surgery at the University Hospital Brno will be screened whether they meet the inclusion criteria. After obtaining informed consent, the patient will be randomized to one of the study arms.
In one arm (STANDARD) standard monitoring of vital signs will be introduced. During the operation, perioperative fluid therapy and administration of vasoactive agents will depend entirely at the discretion of the attending anaesthetist. Postoperative therapy will be fully controlled and will depend on the decision of the attending physician. In the second arm (GDT), a non-invasive hemodynamic monitor STARLINK™SV will be introduced in addition to standard monitoring. In this arm, basal infusion with crystalloid balanced solution will be initiated. Additional boluses of fluids will be administered based on haemodynamic monitoring. The primary outcome of the study is a proportion of patients with serious adverse event (SAE). Incidence of SAEs will be compared between study groups. SAE will be defined as unsatisfactory brain tissue relaxation at the end of operation and any intervention for brain oedema postoperatively.
The secondary outcome is to compare proportion of patients with postoperative complications in both groups and length of ICU and hospital stay.
This study will enroll 34 patients in total, 17 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 | Experimental | Other: STANDARDIn this arm standard monitoring of vital signs will be used during operation. |
| GDT | 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 (4 listed)
- age at least 18 years
- anticipated duration of surgery at least 2 hours
- signed written consent form
- American Society of Anesthesiologists (ASA) classification < 4.
Key exclusion criteria (8 listed)
- unavailability of hemodynamic monitor
- emergency operation
- ASA ≥4
- sitting operating position and awake craniotomy
- awake craniotomy
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 |
|---|---|---|
| Goal-Directed TherapyAdministration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring | Other | GDT |
| STANDARDAdministration of fluids and vasoactive drugs guided by standard vital signs monitoring | Other | STANDARD |
Primary outcome
Serious Adverse Events 1
Time frame: During the Surgery
Assessment of number of patients with serious adverse event (SAE). SAE is defined as unsatisfactory brain tissue relaxation at the end of surgery assessed by neurosurgeon. Level 3 or 4 of brain tissue relaxation will be considered as unsatisfactory (level 1 - completely relaxed, level 2 - satisfactorily relaxed, level 3 - firm, level 4 - bulging).
Serious Adverse Events 2
Time frame: 24 hours postoperatively
Assessment of number of patients with serious adverse event (SAE). SAE is defined as any intervention indicated for treatment of brain edema 24 hours after surgery.
Recruitment rate
Time frame: through study completion, an average of 6 months
Proportion of eligible patients who consent to participate in the study.
Completeness of Case Report Forms
Time frame: through study completion, an average of 6 months
Proportion of enrolled patients with completed Case Report Form.
1 secondary outcome
Complications
Time frame: through study completion, an average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Derived from this study: PubMed 37408018Hrdy O, Duba M, Dolezelova A, Roskova I, Hlavaty M, Traj R, Bonisch V, Smrcka M, Gal R. Effects of goal-directed fluid management guided by a non-invasive device on the incidence of postoperative complications in neurosurgery: a pilot and feasibility randomized controlled trial. Perioper Med (Lond). 2023 Jul 5;12(1):32. doi: 10.1186/s13741-023-00321-3.
- 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. This study is not recruiting at the moment.
Roman Gal, M.D., Ph.D. principal investigator
Masaryk University Brno and 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 Goal-Directed Therapy and STANDARD 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 4 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious Adverse Events 1 (time frame: During the Surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04754295, which also lists 1 linked publication.
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 4 May 2022.