Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery

NCT00766519 | Completed Phase 4

• 3 other identifiers: 2007-A01436-47PHRC 2006/19152007/0723
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 6

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

Conditions

Hemodynamic Instability; Surgery

Keywords

fluid responsiveness; monitoring; arterial pulse pressure

Outcome Measures

Primary Outcomes (1)

• Total number of patients with complications

  first 7 postoperative days

Secondary Outcomes (7)

• 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

Study Arms (2)

Optimization

EXPERIMENTAL

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

control; standard volume administration

ACTIVE COMPARATOR

standard volume administration

Other: standard volume administration

Interventions

volume optimization OTHER

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%

Also known as: preload optimization

Optimization

standard volume administration OTHER

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

Also known as: fluid compensation

control; standard volume administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• major elective intrabdominal surgery

You may not qualify if:

• arrhythmia
• hepatectomy
• associated thoracic surgery
• laparoscopy
• pregnancy
• allergy to colloid solution or anesthesia protocol
• arterial catheter not possible

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (6)

University Hospital

Amiens, 80054, France

Location

University Hospital

Caen, 14033, France

Location

Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU

Clermont-Ferrand, 63000, France

Location

University hospital Henri-Mondor

Créteil, 94010, France

Location

University Hospital

Lille, 59000, France

Location

University Hospital

Rouen, 76031, France

Location

Study Officials

• Benoit TAVERNIER, MD, PhD

  University Hospital, Lille

  STUDY DIRECTOR

• Benoit VALLET, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2008
• First Posted: October 6, 2008
• Study Start: February 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

FR (6)