Effect of Intraoperative Fluid Management on Morbidity - Full Text View

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

MedlinePlus related topics:

Anesthesia

U.S. FDA Resources

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

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:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

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

Responsible Party:	Department of Anesthesiology and Intensive Care, University Hospital Muenster ( Martin Westphal, MD )
Study ID Numbers:	02-Anast-05
First Received:	September 8, 2005
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00156338
Health Authority:	Germany: Ethics Commission

Keywords provided by University Hospital Muenster:

Fluid therapy

ClinicalTrials.gov processed this record on October 10, 2008

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