Effect of Intraoperative Fluid Management on Morbidity

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital Muenster

ClinicalTrials.gov Identifier:

NCT00156338

First received: September 8, 2005

Last updated: January 16, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

January 16, 2012

Start Date ^ICMJE

July 2005

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

all cause Morbidity [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Morbidity at 1 year

Change History

Complete list of historical versions of study NCT00156338 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Gastral and intestinal function
Mortality

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Intraoperative Fluid Management on Morbidity

Official Title ^ICMJE

Effect of Intraoperative Fluid Management on Morbidity in Patients Undergoing Colorectal Surgery

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Epidural Anesthesia

Intervention ^ICMJE

Procedure: fluid management
volume and sodium restriction
Procedure: fluid management
volume restriction
Procedure: fluid management
liberal fluid management

Study Arm (s)

Experimental: 1
volume and sodium restriction

Intervention: Procedure: fluid management
Active Comparator: 2
volume restriction

Intervention: Procedure: fluid management
Active Comparator: 3
liberal fluid management

Intervention: Procedure: fluid management

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

108

Completion Date

December 2010

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

epidural anesthesia
ASA I-III

Exclusion Criteria:

metastasized cancer
pregnancy

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00156338

Other Study ID Numbers ^ICMJE

02-Anast-05

Has Data Monitoring Committee

Responsible Party

University Hospital Muenster

Study Sponsor ^ICMJE

University Hospital Muenster

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Martin Westphal, MD

Department of Anesthesiology and Intensive Care, University Hospital Münster

Information Provided By

University Hospital Muenster

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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