MedDataX Logo

Effect of Intraoperative Volume Optimization on Outcome After Intrabdominal Surgery

NCT ID: NCT00766519

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodynamic Instability Surgery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fluid responsiveness monitoring arterial pulse pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

volume optimization

Intervention Type 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%

control; standard volume administration

standard volume administration

Group Type ACTIVE_COMPARATOR

standard volume administration

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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%

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

preload optimization fluid compensation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benoit TAVERNIER, MD, PhD

Role: STUDY_DIRECTOR

University Hospital, Lille

Benoit VALLET, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital

Amiens, , France

Site Status

University Hospital

Caen, , France

Site Status

Département d'Anesthésie-Réanimation, Hôpital Estaing, CHU

Clermont-Ferrand, , France

Site Status

University hospital Henri-Mondor

Créteil, , France

Site Status

University Hospital

Lille, , France

Site Status

University Hospital

Rouen, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHRC 2006/1915

Identifier Type: OTHER

Identifier Source: secondary_id

2007/0723

Identifier Type: OTHER

Identifier Source: secondary_id

2007-A01436-47

Identifier Type: -

Identifier Source: org_study_id