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Clinical Trials/NCT00766519
NCT00766519
Completed
Phase 4

Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery: a Multicenter, Randomized, Double-blind, Comparative Study

University Hospital, Lille3 sites in 1 country104 target enrollmentFebruary 2009

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.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
April 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

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)

Study Sites (3)

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