Effect of Intraoperative Fluid Management on Morbidity
January 16, 2012 updated by: University Hospital Muenster
Effect of Intraoperative Fluid Management on Morbidity in Patients Undergoing Colorectal Surgery
The purpose of this study is to determine whether intraoperative fluid and sodium restriction decreases postoperative morbidity
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Münster, Germany, D-48149
- Department of Anesthesiology and Intensive Care, University Hospital Münster
-
Münster, Germany, D-48143
- Raphaelsklinik
-
Münster, Germany, D-48145
- St. Franziskus-Hospital Münster
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- epidural anesthesia
- ASA I-III
Exclusion Criteria:
- metastasized cancer
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
volume and sodium restriction
|
volume and sodium restriction
volume restriction
liberal fluid management
|
|
Active Comparator: 2
volume restriction
|
volume and sodium restriction
volume restriction
liberal fluid management
|
|
Active Comparator: 3
liberal fluid management
|
volume and sodium restriction
volume restriction
liberal fluid management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
all cause Morbidity
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Gastral and intestinal function
Time Frame: within the first 30 days after surgery
|
within the first 30 days after surgery
|
|
all cause Mortality
Time Frame: one year
|
one year
|
|
Gastral and intestinal function
Time Frame: one year after surgery
|
one year after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Westphal, MD, Department of Anesthesiology and Intensive Care, University Hospital Münster
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
January 18, 2012
Last Update Submitted That Met QC Criteria
January 16, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 02-Anast-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.