Effect of Intraoperative Fluid Management on Morbidity
Sponsor
University Hospital Muenster (Other)
Overall Status
Completed
CT.gov ID
NCT00156338
Collaborator
(none)
108
3
3
65
36
0.6
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Jul 1, 2005
Actual Primary Completion Date
:
Dec 1, 2009
Actual Study Completion Date
:
Dec 1, 2010
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- all cause Morbidity [one year]
Secondary Outcome Measures
- Gastral and intestinal function [within the first 30 days after surgery]
- all cause Mortality [one year]
- Gastral and intestinal function [one year after surgery]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
epidural anesthesia
-
ASA I-III
Exclusion Criteria:
-
metastasized cancer
-
pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Raphaelsklinik | Münster | Germany | D-48143 | |
| 2 | St. Franziskus-Hospital Münster | Münster | Germany | D-48145 | |
| 3 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00156338
Other Study ID Numbers:
- 02-Anast-05
First Posted:
Sep 12, 2005
Last Update Posted:
Jan 18, 2012
Last Verified:
Jan 1, 2012
Keywords provided by University Hospital Muenster