Clinical trial NCT02625701: Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy
Official title: Perioperative Fluid Management: Goal-Directed Therapy vs. Restrictive Approach, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: composite index of serious postoperative adverse events
timeFrame: from date of surgery till hospital discharge or 30-day postoperative
Secondary outcomes:
measure: body weight changes (kg, postoperative value - preoperative value)
timeFrame: from date of surgery till hospital discharge, or 30-day postoperative
measure: fluid balance
timeFrame: intra-operative and first 24hours after surgery
measure: Acute Kidney Injury based on RIFLE
timeFrame: from the day before to 3 days after surgery
measure: Sequential Organ Failure Assessment (SOFA)
timeFrame: from date of surgery till hospital discharge, up to 15 weeks after date of surgery
measure: tissue oximetry (%)
timeFrame: intraoperative period, day of surgery
measure: survival
timeFrame: survival 1-3 years after surgery
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva, Department of Anesthesiology
Study officials:
affiliation: University Hospital, Geneva
name: Marc Licker, MD
role: PRINCIPAL_INVESTIGATOR
References: