Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy

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.

Study Overview

• Status: Completed
• Conditions: Complication, Postoperative
• Intervention / Treatment: Procedure: Goal-directed therapy; Procedure: Restrictive fluid therapy

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • University Hospital of Geneva, Department of Anesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goal-Directed-Therapy (GDT); 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).	Procedure: Goal-directed therapy; Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume); Other Names: GDT
Active Comparator: Restrictive strategy; 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	Procedure: Restrictive fluid therapy; Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body weight changes (kg, postoperative value - preoperative value)	comparison of body weight (preop versus postop value, kg)	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	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 (%)	from the day before to 3 days after surgery
Sequential Organ Failure Assessment (SOFA)	scoring the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems	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)	intraoperative period, day of surgery
survival	patients (family, next of kin, doctor) are contacted by phone or mail	survival 1-3 years after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Marc Licker, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: March 22, 2012
• First Submitted That Met QC Criteria: December 8, 2015
• First Posted (Estimate): December 9, 2015

Study Record Updates

• Last Update Posted (Actual): September 12, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: acute kidney injury; surgical site infection; body weight; operative mortality; myocardial infarct, arrhythmia, heart failure, stroke; pneumonia, atelectasis, acute lung injury
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: UGeneve - NAC09-022