Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy

NCT ID: NCT02625701

Last Updated: 2019-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2019-09-30

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.

Conditions

Complication, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Goal-directed therapy

Intervention Type: PROCEDURE

Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume)

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

Group Type: ACTIVE_COMPARATOR

Restrictive fluid therapy

Intervention Type: PROCEDURE

Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.

Interventions

Goal-directed therapy

Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume)

Intervention Type: PROCEDURE

Restrictive fluid therapy

Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.

Intervention Type: PROCEDURE

Other Intervention Names

GDT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Marc Licker

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Licker, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University Hospital of Geneva, Department of Anesthesiology

Geneva, , Switzerland

Countries

Switzerland

Other Identifiers

UGeneve - NAC09-022

Identifier Type: -

Identifier Source: org_study_id