Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy

Phase 3

Completed

• Conditions: Complication, Postoperative
• Interventions: Procedure: Goal-directed therapy; Procedure: Restrictive fluid therapy

• Registration Number: NCT02625701
• Lead Sponsor: University Hospital, Geneva

Brief 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 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 Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2015-12-08
• Study First Posted: 2015-12-09
• Status Verified: 2019-09
• Primary Completion: 2019-09
• Study Completion: 2019-09
• Last Update Submitted: 2019-09-09
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• adult patient
• elective noncardiac surgery (moderate-high-risk) lasting > 2h hours (, gastrectomy, pancreatectomy, nephrectomy, radical cystectomy, hepatic resection, open colonic or rectal surgery)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Goal-Directed-Therapy (GDT)	Goal-directed therapy	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).
Restrictive strategy	Restrictive fluid therapy	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

Primary Outcome Measures

Name	Time	Method
composite index of serious postoperative adverse events	from date of surgery till hospital discharge or 30-day postoperative	early postoperative major outcomes: mortality, cardiovascular, respiratory, renal and infectious complications

Secondary Outcome Measures

Name	Time	Method
fluid balance	intra-operative and first 24hours after surgery	amount of fluids (ml) infused, amount of fluid losses; change in body weight
survival	survival 1-3 years after surgery	patients (family, next of kin, doctor) are contacted by phone or mail
body weight changes (kg, postoperative value - preoperative value)	from date of surgery till hospital discharge, or 30-day postoperative	comparison of body weight (preop versus postop value, kg)
Sequential Organ Failure Assessment (SOFA)	from date of surgery till hospital discharge, up to 15 weeks after date of surgery	scoring the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems
tissue oximetry (%)	intraoperative period, day of surgery	Monitoring of oxygen delivery/utilization in the brain area with near-infra-red spectroscopy (NIRS)
Acute Kidney Injury based on RIFLE	from the day before to 3 days after surgery	measurements of creatinine (preoperative, postoperative day 1, 2, 3 after surgery) and assessing the changes in glomerular filtration rate (%)

Trial Locations

Locations (1)

University Hospital of Geneva, Department of Anesthesiology; 🇨🇭 Geneva, Switzerland