Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery

Phase 4

Completed

• Conditions: Surgery; Hemodynamic Instability
• Interventions: Other: standard volume administration; Other: volume optimization

• Registration Number: NCT00766519
• Lead Sponsor: University Hospital, Lille

Brief Summary

The purpose of this study is to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on respiratory-induced pulse pressure variation monitoring may improve outcome after intrabdominal surgery

Detailed Description

Recent studies strongly suggest that intraoperative oesophageal doppler guided fluid management may improve outcome after intrabdominal surgery. In these studies, however, the number of patients was often small, and management in control groups as well as postoperative complications were usually not precisely defined. In addition, widespread use of oesophageal doppler cannot be advocated in routine surgery, and the strategy necessitates repeated volume loading. This may lead to unnecessary intravenous fluids which may be deleterious, and intraoperative fluid restriction has also been shown to improve clinical outcome. In this context, indices reflecting the hemodynamic changes during mechanical ventilation (the so-called "dynamic indices", and more specifically the respiratory-induced pulse pressure variation) have been shown to accurately predict fluid responsiveness in mechanically ventilated patients. Automated and continuous calculation of pulse pressure variation variation from standard peripheral (typically radial) arterial line has recently been validated. This study was thus designed to determine whether intraoperative goal-directed fluid management (with goal = cardiac stroke volume maximization) based on pulse pressure variation monitoring would improve outcome after intrabdominal surgery.

Study Timeline

• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Study First Posted: 2008-10-06
• Study Start: 2009-02
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

Inclusion Criteria

• major elective intrabdominal surgery

Exclusion Criteria

• arrhythmia
• hepatectomy
• associated thoracic surgery
• laparoscopy
• pregnancy
• allergy to colloid solution or anesthesia protocol
• arterial catheter not possible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control; standard volume administration	standard volume administration	standard volume administration
Optimization	volume optimization	volume optimization: continuous monitoring of the respiratory-induced arterial pulse pressure variation during surgery and systematic minimization to 10% or less by volume loading

Primary Outcome Measures

Name	Time	Method
Total number of patients with complications	first 7 postoperative days

Secondary Outcome Measures

Name	Time	Method
Time to initial passage of flatus and feces	postoperative
total number of complications	first 7 postoperative days
Duration of hospital stay	postoperative
SOFA (Sequential Organ Failure Assessment) score	postoperative days 1 and 5
duration of stay in intensive care unit	postoperative
death	in-hospital and postoperative day 28
volumes of fluid administered	duration of surgery

Trial Locations

Locations (3)

University Hospital; 🇫🇷 Rouen, France

Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU; 🇫🇷 Clermont-ferrand, France

University hospital Henri-Mondor; 🇫🇷 Créteil, France