Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery (EVOLUTION)

University Hospital, Lille

Status and phase: Completed; Phase 4

Conditions: Hemodynamic Instability; Surgery

Treatments: Other: volume optimization; Other: standard volume administration

Study type: Interventional

Funder types: Other

Identifiers

NCT00766519

2007-A01436-47

2007/0723 (Other Identifier)

PHRC 2006/1915 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 2 patient groups

Optimization

Experimental group

Description:

volume optimization: continuous monitoring of the respiratory-induced arterial pulse pressure variation during surgery and systematic minimization to 10% or less by volume loading

Treatment:

Other: volume optimization

control; standard volume administration

Active Comparator group

Description:

standard volume administration

Treatment:

Other: standard volume administration