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
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:
  • all cause Morbidity [ Time Frame: one year ] [ Designated as safety issue: No ]

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 ]

Enrollment: 108
Study Start Date: July 2005
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
volume and sodium restriction
Procedure: fluid management
volume and sodium restriction
Active Comparator: 2
volume restriction
Procedure: fluid management
volume restriction
Active Comparator: 3
liberal fluid management
Procedure: fluid management
liberal fluid management

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • epidural anesthesia
  • ASA I-III

Exclusion Criteria:

  • metastasized cancer
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Department of Anesthesiology and Intensive Care, University Hospital Münster
Münster, Germany, D-48149
Raphaelsklinik
Münster, Germany, D-48143
St. Franziskus-Hospital Münster
Münster, Germany, D-48145
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: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00156338     History of Changes
Other Study ID Numbers: 02-Anast-05
Study First Received: September 8, 2005
Last Updated: January 16, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Muenster:
Fluid therapy

ClinicalTrials.gov processed this record on September 18, 2014