Clinical trial NCT00766519: Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery
Official title: Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery: a Multicenter, Randomized, Double-blind, Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodynamic Instability
Surgery
Keywords: fluid responsiveness
monitoring
arterial pulse pressure
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2008-10-06
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total number of patients with complications
timeFrame: first 7 postoperative days
Secondary outcomes:
measure: total number of complications
timeFrame: first 7 postoperative days
measure: SOFA (Sequential Organ Failure Assessment) score
timeFrame: postoperative days 1 and 5
measure: Time to initial passage of flatus and feces
timeFrame: postoperative
measure: duration of stay in intensive care unit
timeFrame: postoperative
measure: Duration of hospital stay
timeFrame: postoperative
measure: death
timeFrame: in-hospital and postoperative day 28
measure: volumes of fluid administered
timeFrame: duration of surgery
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital
city: Caen
country: France
facility: University Hospital
city: Clermont-ferrand
country: France
facility: Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU
city: Créteil
country: France
facility: University hospital Henri-Mondor
city: Lille
country: France
facility: University Hospital
city: Rouen
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Lille
name: Benoit TAVERNIER, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Hospital, Lille
name: Benoit VALLET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: