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Effect of Intraoperative Fluid Management on Morbidity

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ClinicalTrials.gov Identifier: NCT00156338
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital Muenster

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

Condition or disease Intervention/treatment Phase
Epidural Anesthesia Procedure: fluid management Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Intraoperative Fluid Management on Morbidity in Patients Undergoing Colorectal Surgery
Study Start Date : July 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. all cause Morbidity [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Gastral and intestinal function [ Time Frame: within the first 30 days after surgery ]
  2. all cause Mortality [ Time Frame: one year ]
  3. Gastral and intestinal function [ Time Frame: one year after surgery ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • epidural anesthesia
  • ASA I-III

Exclusion Criteria:

  • metastasized cancer
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156338


Locations
Germany
Raphaelsklinik
Münster, Germany, D-48143
St. Franziskus-Hospital Münster
Münster, Germany, D-48145
Department of Anesthesiology and Intensive Care, University Hospital Münster
Münster, Germany, D-48149
Sponsors and Collaborators
University Hospital Muenster
Investigators
Principal Investigator: Martin Westphal, MD Department of Anesthesiology and Intensive Care, University Hospital Münster

Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00156338     History of Changes
Other Study ID Numbers: 02-Anast-05
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by University Hospital Muenster:
Fluid therapy