Effect of Intraoperative Fluid Management on Morbidity

This study is currently recruiting participants.

Verified by University Hospital Muenster, August 2009

First Received: September 8, 2005 Last Updated: August 12, 2009 History of Changes

Sponsored by:	University Hospital Muenster
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00156338

Purpose

The purpose of this study is to determine whether intraoperative fluid and sodium restriction decreases postoperative morbidity

Condition	Intervention
Epidural Anesthesia	Procedure: fluid management

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Effect of Intraoperative Fluid Management on Morbidity in Patients Undergoing Colorectal Surgery

Resource links provided by NLM:

MedlinePlus related topics: Anesthesia Surgery

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

Secondary Outcome Measures:

Gastral and intestinal function [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: No ]
all cause Mortality [ Time Frame: one year ] [ Designated as safety issue: No ]
Gastral and intestinal function [ Time Frame: one year after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	108
Study Start Date:	July 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental volume and sodium restriction	Procedure: fluid management volume and sodium restriction
2: Active Comparator volume restriction	Procedure: fluid management volume restriction
3: Active Comparator liberal fluid management	Procedure: fluid management liberal fluid management

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156338

Contacts

Contact: Martin Westphal, MD

+49-251-8347255

Locations

Germany
Department of Anesthesiology and Intensive Care, University Hospital Münster	Recruiting
Münster, Germany, D-48149
Contact: Martin Westphal, MD
Principal Investigator: Martin Westphal, MD
Raphaelsklinik	Recruiting
Münster, Germany, D-48143
Contact: N Mertes, MD
St. Franziskus-Hospital Münster	Recruiting
Münster, Germany, D-48145
Contact: M Möllmann, MD

Sponsors and Collaborators

University Hospital Muenster

Investigators

Principal Investigator:

Martin Westphal, MD

Department of Anesthesiology and Intensive Care, University Hospital Münster

More Information

No publications provided

Responsible Party:	Department of Anesthesiology and Intensive Care, University Hospital Muenster ( Martin Westphal, MD )
Study ID Numbers:	02-Anast-05
Study First Received:	September 8, 2005
Last Updated:	August 12, 2009
ClinicalTrials.gov Identifier:	NCT00156338 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Muenster:

Fluid therapy

ClinicalTrials.gov processed this record on September 11, 2009