Effect of Intraoperative Fluid Management on Morbidity

Epidural Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00156338
• Other study ID #: 02-Anast-05
• Status: Completed
• Phase: N/A
• First received: September 8, 2005
• Last updated: January 16, 2012
• Start date: July 2005
• Est. completion date: December 2010

Study information

• Verified date: January 2012
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• epidural anesthesia

• ASA I-III

Exclusion Criteria:

• metastasized cancer

• pregnancy

Study Design

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

Related Conditions & MeSH terms

• Epidural Anesthesia

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care, University Hospital Münster	Münster
Germany	Raphaelsklinik	Münster
Germany	St. Franziskus-Hospital Münster	Münster

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause Morbidity		one year	No
Secondary	Gastral and intestinal function		within the first 30 days after surgery	No
Secondary	all cause Mortality		one year	No
Secondary	Gastral and intestinal function		one year after surgery	No