Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery: a Multicenter, Randomized, Double-blind, Comparative Study
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Hemodynamic Instability
- Sponsor
- University Hospital, Lille
- Enrollment
- 104
- Locations
- 3
- Primary Endpoint
- Total number of patients with complications
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Total number of patients with complications
Time Frame: first 7 postoperative days
Secondary Outcomes
- 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)
- Time to initial passage of flatus and feces(postoperative)