Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy

Complication, Postoperative Clinical Trial

Official title:

Perioperative Fluid Management: Goal-Directed Therapy vs. Restrictive Approach, a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625701
• Other study ID #: UGeneve - NAC09-022
• Status: Completed
• Phase: Phase 3
• Start date: January 2012
• Est. completion date: September 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complication, Postoperative
• Postoperative Complications

Intervention

Procedure:
• Goal-directed therapy
Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume)
• Restrictive fluid therapy
Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva, Department of Anesthesiology	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	fluid balance	amount of fluids (ml) infused, amount of fluid losses; change in body weight	intra-operative and first 24hours after surgery
Secondary	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
Secondary	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
Secondary	tissue oximetry (%)	Monitoring of oxygen delivery/utilization in the brain area with near-infra-red spectroscopy (NIRS)	intraoperative period, day of surgery
Secondary	survival	patients (family, next of kin, doctor) are contacted by phone or mail	survival 1-3 years after surgery