Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemodynamic Instability, Surgery

Intervention / Treatment
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* Other: volume optimization
* Other: standard volume administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimization<br>volume optimization: continuous monitoring of the respiratory-induced arterial pulse pressure variation during surgery and systematic minimization to 10% or less by volume loading | Other: volume optimization<br>* Fluid management: basal fluid administration = 5 ml/kg/h lactated Ringer's solution + systematic minimization of the arterial pulse pressure variation (PPV) to 10% or less by volume loading (6% hydroxyethyl starch) throughout surgery hypovolemia suspected : fluids (1. crystalloids, 2. 6% hydroxyethyl starch) only if PPV is > 10%<br>* Other names: preload optimization;|
| Active Comparator: control; standard volume administration<br>standard volume administration | Other: standard volume administration<br>* Fluid management: basal fluid administration = 5 ml/kg/h lactated Ringer's solution hypovolemia suspected : fluids (1. crystalloids, 2. 6% hydroxyethyl starch) according to predetermined algorithm primarily based on mean arterial pressure, heart rate, and urine output, and secondary on PPV<br>* Other names: fluid compensation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of patients with complications |  | first 7 postoperative days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluid responsiveness, monitoring, arterial pulse pressure