NCT00156338

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

4.4 years

First QC Date

September 8, 2005

Last Update Submit

January 16, 2012

Conditions

Epidural Anesthesia

Keywords

Fluid therapy

Outcome Measures

Primary Outcomes (1)

  • all cause Morbidity

    one year

Secondary Outcomes (3)

  • Gastral and intestinal function

    within the first 30 days after surgery

  • all cause Mortality

    one year

  • Gastral and intestinal function

    one year after surgery

Study Arms (3)

1

EXPERIMENTAL

volume and sodium restriction

Procedure: fluid management

2

ACTIVE COMPARATOR

volume restriction

Procedure: fluid management

3

ACTIVE COMPARATOR

liberal fluid management

Procedure: fluid management

Interventions

fluid managementPROCEDURE

volume and sodium restriction

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • epidural anesthesia
  • ASA I-III

You may not qualify if:

  • metastasized cancer
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Raphaelsklinik

Münster, D-48143, Germany

Location

St. Franziskus-Hospital Münster

Münster, D-48145, Germany

Location

Department of Anesthesiology and Intensive Care, University Hospital Münster

Münster, D-48149, Germany

Location

Study Officials

  • Martin Westphal, MD

    Department of Anesthesiology and Intensive Care, University Hospital Münster

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

July 1, 2005

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations

DE(3)