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

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

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

Study Overview

• Status: Completed
• Conditions: Surgery; Hemodynamic Instability
• Intervention / Treatment: Other: volume optimization; Other: standard volume administration

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.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • University Hospital
  • Caen, France, 14033
    • University Hospital
  • Clermont-ferrand, France, 63000
    • Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU
  • Créteil, France, 94010
    • University hospital Henri-Mondor
  • Lille, France, 59000
    • University Hospital
  • Rouen, France, 76031
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Optimization; 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; 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%; Other Names: preload optimization
Active Comparator: control; standard volume administration; standard volume administration	Other: standard volume administration; 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; Other Names: fluid compensation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Study Director: Benoit TAVERNIER, MD, PhD, University Hospital, Lille; Principal Investigator: Benoit VALLET, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: October 3, 2008
• First Submitted That Met QC Criteria: October 3, 2008
• First Posted (Estimate): October 6, 2008

Study Record Updates

• Last Update Posted (Estimate): November 19, 2013
• Last Update Submitted That Met QC Criteria: November 18, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: fluid responsiveness; monitoring; arterial pulse pressure
• Other Study ID Numbers: 2007-A01436-47; PHRC 2006/1915 (Other Identifier: DHOS); 2007/0723 (Other Identifier: sponsor)