Complication, PostoperativePhase 3NCT02625701
Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy
A Phase 3 study testing Goal-directed therapy and Restrictive fluid therapy in people with Complication, Postoperative, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
There is no ideal "cookbook recipe" for fluid prescription that would fit every surgical patient. In this study, the investigators working hypothesis is that the adoption of an integrative algorithm for perioperative fluid and haemodynamic management would improve clinical outcome and reduce hospital resource… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication, Postoperative
- What is being tested?
- Goal-directed therapy and Restrictive fluid therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Sep 2019
- Phase
- Phase 3
- 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
- adult patient
- elective noncardiac surgery (moderate-high-risk) lasting > 2h hours (, gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery)
Who cannot join
- end-stage organ failure (hemofiltration/dialysis; Child-Pugh class C or MELD score >22; predicted forced expiratory volume < 30%, severe heart failure)
- life expectancy < 24h
- psychiatric disorders or unability to give independent consent to the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Geneva, Department of Anesthesiology
Geneva, 1211
About this study
Official title: Perioperative Fluid Management: Goal-Directed Therapy vs. Restrictive Approach, a Randomized Controlled Trial
There is no ideal "cookbook recipe" for fluid prescription that would fit every surgical patient.
In this study, the investigators working hypothesis is that the adoption of an integrative algorithm for perioperative fluid and haemodynamic management would improve clinical outcome and reduce hospital resource utilization in noncardiac surgical procedures (major-to-intermediate level of stress.
Two intraoperative fluid strategies will be compared: "Restrictive" vs. "goal-directed therapy (GDT)". In the GDT group, haemodynamic information will be obtained by a flow monitoring device coupled with standard heart rate and blood pressure monitoring.
Read the detailed description
The rationale of minimizing body weight gain and avoiding unnecessary fluid compensation of the "third compartment" is now well justified and achievement of supra-normal oxygen delivery values is likely not necessary in most surgical patients. Therefore,it would be tempting to adopt fluid restriction protocols given the potentials of better wound healing, faster return of bowel function and shorter hospital stay after major surgical procedures.
Although dynamic flow indices of volume responsiveness have been validated in critically-ill patients, concerns have been raised regarding the risk of overzealous fluid administration in non-critically-ill patients undergoing elective surgery.
To date, RCTs comparing fluid regimen ("liberal" versus "restrictive" or "liberal" versus "GDT") have yielded controversial results with no consensus regarding appropriate fluid administration in the perioperative period. Interestingly, restrictive protocols have been associated with more frequent adverse events (e.g., nausea, vomiting) following minor surgical procedures and concerns have been raised regarding the possibility of tissue hypoperfusion leading to end-organ dysfunction.
- Conditions
- Complication, Postoperative
- Being tested
- Goal-directed therapy, Restrictive fluid therapy
- Keywords
- operative mortality, myocardial infarct, arrhythmia, heart failure, stroke, pneumonia, atelectasis, acute lung injury, surgical site infection, acute kidney injury, body weight
- Medical subject headings
- Postoperative Complications, Myocardial Infarction, Arrhythmias, Cardiac, Heart Failure, Stroke, Pneumonia, Pulmonary Atelectasis, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-directed therapyProcedure or surgery
Also called GDT
Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume)
Restrictive fluid therapyProcedure or surgery
Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.
| Study group | Role | What they receive |
|---|---|---|
| Goal-Directed-Therapy (GDT) | Experimental | Besides the basal infusion of crystalloids at 3-6 ml/kg/h, colloids (200 ml) or crystalloids (200 ml) are given over 10 min in the presence of signs of absolute/relative hypovolemia as detected by a fall in cardiac output/stroke volume (CO/SV) or if Pressure Pulse Variation (PVV) or Stroke Volume Variation (SVV) exceeds 10-12%, particularly in the presence. Fluid filling is interrupted when SV fail to increase > 10% (or PVV/SVV =< 10%) Otherwise, vasopressors can be used to achieve appropriate mean arterial pressure (MAP>70 mmHg, within ±20% of baseline).
Blood losses are replaced with colloids (1:1) or crystalloids (2:1). Receives: Procedure: Goal-directed therapy |
| Restrictive strategy | Active comparator | Crystalloids are given at a fixed rate of 3-6 ml/kg/h. Otherwise, vasopressors can be used to achieve appropriate MAP (>70 mmHg, within ±20% of baseline).
Blood losses are replaced with colloids (1:1) or crystalloids (2:1). Clinicians in charge of the patients are free to use hemodynamic parameters such as PVV or SVV, always attempting to limit the amount of fluid infusion and to maintain normovolemia Receives: Procedure: Restrictive fluid therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite index of serious postoperative adverse events
early postoperative major outcomes: mortality, cardiovascular, respiratory, renal and infectious complications
Measured: from date of surgery till hospital discharge or 30-day postoperative
Secondary outcomes (6)
body weight changes (kg, postoperative value - preoperative value)
comparison of body weight (preop versus postop value, kg)
Measured: from date of surgery till hospital discharge, or 30-day postoperative
fluid balance
amount of fluids (ml) infused, amount of fluid losses
change in body weight
Measured: intra-operative and first 24hours after surgery
Acute Kidney Injury based on RIFLE
measurements of creatinine (preoperative, postoperative day 1, 2, 3 after surgery) and assessing the changes in glomerular filtration rate (%)
Measured: from the day before to 3 days after surgery
Sequential Organ Failure Assessment (SOFA)
scoring the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems
Measured: from date of surgery till hospital discharge, up to 15 weeks after date of surgery
tissue oximetry (%)
Monitoring of oxygen delivery/utilization in the brain area with near-infra-red spectroscopy (NIRS)
Measured: intraoperative period, day of surgery
survival
patients (family, next of kin, doctor) are contacted by phone or mail
Measured: survival 1-3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJan 2012
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication, PostoperativeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Licker, University Hospital, Geneva
- Investigators
- Marc Licker, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625701
- Sponsor's protocol ID
- UGeneve - NAC09-022
- Status last verified
- Sep 2019
- First submitted
- 22 Mar 2012
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Fluid Management: Goal-Directed Therapy vs. Restrictive Approach, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02625701
- Acronym / sponsor ID
- UGeneve - NAC09-022
- Conditions
- Complication, Postoperative
- Keywords
- operative mortality, myocardial infarct, arrhythmia, heart failure, stroke, pneumonia, atelectasis, acute lung injury, surgical site infection, acute kidney injury, body weight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 9 Dec 2015 (estimated)
- 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.
There is no ideal "cookbook recipe" for fluid prescription that would fit every surgical patient.
In this study, the investigators working hypothesis is that the adoption of an integrative algorithm for perioperative fluid and haemodynamic management would improve clinical outcome and reduce hospital resource utilization in noncardiac surgical procedures (major-to-intermediate level of stress.
Two intraoperative fluid strategies will be compared: "Restrictive" vs. "goal-directed therapy (GDT)". In the GDT group, haemodynamic information will be obtained by a flow monitoring device coupled with standard heart rate and blood pressure monitoring.
Detailed description
The rationale of minimizing body weight gain and avoiding unnecessary fluid compensation of the "third compartment" is now well justified and achievement of supra-normal oxygen delivery values is likely not necessary in most surgical patients. Therefore,it would be tempting to adopt fluid restriction protocols given the potentials of better wound healing, faster return of bowel function and shorter hospital stay after major surgical procedures.
Although dynamic flow indices of volume responsiveness have been validated in critically-ill patients, concerns have been raised regarding the risk of overzealous fluid administration in non-critically-ill patients undergoing elective surgery.
To date, RCTs comparing fluid regimen ("liberal" versus "restrictive" or "liberal" versus "GDT") have yielded controversial results with no consensus regarding appropriate fluid administration in the perioperative period. Interestingly, restrictive protocols have been associated with more frequent adverse events (e.g., nausea, vomiting) following minor surgical procedures and concerns have been raised regarding the possibility of tissue hypoperfusion leading to end-organ dysfunction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal-Directed-Therapy (GDT) | Experimental | Procedure: Goal-directed therapyBesides the basal infusion of crystalloids at 3-6 ml/kg/h, colloids (200 ml) or crystalloids (200 ml) are given over 10 min in the presence of signs of absolute/relative hypovolemia as detected by a fall in cardiac output/stroke volume (CO/SV) or if Pressure Pulse Variation (PVV) or Stroke Volume Variation (SVV) exceeds 10-12%, particularly in the presence. Fluid filling is interrupted when SV fail to increase > 10% (or PVV/SVV =< 10%) Otherwise, vasopressors can be used to achieve appropriate mean arterial pressure (MAP>70 mmHg, within ±20% of baseline). Blood losses are replaced with colloids (1:1) or crystalloids (2:1). |
| Restrictive strategy | Active comparator | Procedure: Restrictive fluid therapyCrystalloids are given at a fixed rate of 3-6 ml/kg/h. Otherwise, vasopressors can be used to achieve appropriate MAP (>70 mmHg, within ±20% of baseline). Blood losses are replaced with colloids (1:1) or crystalloids (2:1). Clinicians in charge of the patients are free to use hemodynamic parameters such as PVV or SVV, always attempting to limit the amount of fluid infusion and to maintain normovolemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult patient
- elective noncardiac surgery (moderate-high-risk) lasting > 2h hours (, gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery)
Key exclusion criteria (3 listed)
- end-stage organ failure (hemofiltration/dialysis; Child-Pugh class C or MELD score >22; predicted forced expiratory volume < 30%, severe heart failure)
- life expectancy < 24h
- psychiatric disorders or unability to give independent consent to the study
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 therapyAlso: GDTOptimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume) | Procedure or surgery | Goal-Directed-Therapy (GDT) |
| Restrictive fluid therapyKeep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids. | Procedure or surgery | Restrictive strategy |
Primary outcome
composite index of serious postoperative adverse events
Time frame: from date of surgery till hospital discharge or 30-day postoperative
early postoperative major outcomes: mortality, cardiovascular, respiratory, renal and infectious complications
6 secondary outcomes
body weight changes (kg, postoperative value - preoperative value)
Time frame: from date of surgery till hospital discharge, or 30-day postoperative
fluid balance
Time frame: intra-operative and first 24hours after surgery
Acute Kidney Injury based on RIFLE
Time frame: from the day before to 3 days after surgery
Sequential Organ Failure Assessment (SOFA)
Time frame: from date of surgery till hospital discharge, up to 15 weeks after date of surgery
tissue oximetry (%)
Time frame: intraoperative period, day of surgery
survival
Time frame: survival 1-3 years after surgery
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 12 Sep 2019.
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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.
Marc Licker, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Goal-directed therapy and Restrictive fluid therapy in people with Complication, Postoperative, run by University Hospital, Geneva at 1 site in Switzerland.
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 2 inclusion and 3 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 12 Sep 2019. 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 Switzerland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
composite index of serious postoperative adverse events (time frame: from date of surgery till hospital discharge or 30-day postoperative). 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 12 Sep 2019.