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CompletedNCT00156338Updated Jan 18, 2012

Effect of Intraoperative Fluid Management on Morbidity

An interventional study of fluid management and fluid management in Epidural Anesthesia, sponsored by University Hospital Muenster. Completed at 3 sites in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-01-18.

Sponsored by University Hospital Muenster · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Epidural Anesthesia

Keywords

  • Fluid therapy
03

In context

Lead sponsor

University Hospital Muenster is the lead sponsor of 189 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • epidural anesthesia
  • ASA I-III

Exclusion criteria

Exclusion Criteria:

  • metastasized cancer
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
108 participants (actual)

Study arms

  • Experimental
    1

    volume and sodium restriction

    Procedure: fluid management

  • Active comparator
    2

    volume restriction

    Procedure: fluid management

  • Active comparator
    3

    liberal fluid management

    Procedure: fluid management

Interventions

  • Procedurefluid management

    volume and sodium restriction

  • Procedurefluid management

    volume restriction

  • Procedurefluid management

    liberal fluid management

06

What researchers measure

Primary outcomes

  1. all cause Morbidity

    Time frame: one year

Secondary outcomes

  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

07

Study locations

3 sites
  • Raphaelsklinik
    Münster, D-48143, Germany
  • St. Franziskus-Hospital Münster
    Münster, D-48145, Germany
  • Department of Anesthesiology and Intensive Care, University Hospital Münster
    Münster, D-48149, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00156338
Lead sponsor
University Hospital Muenster
Responsible party
Sponsor
First posted
Sep 12, 2005
Start date
Jul 2005
Primary completion
Dec 2009
Completion
Dec 2010
Last update
Jan 18, 2012

Study contacts

Martin Westphal, MD
principal investigator · Department of Anesthesiology and Intensive Care, University Hospital Münster

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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