Effect of Intraoperative Fluid Management on Morbidity

NCT ID: NCT00156338

Last Updated: 2012-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-12-31

Brief Summary

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

Detailed Description

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Conditions

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Epidural Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

volume and sodium restriction

Group Type EXPERIMENTAL

fluid management

Intervention Type PROCEDURE

volume and sodium restriction

2

volume restriction

Group Type ACTIVE_COMPARATOR

fluid management

Intervention Type PROCEDURE

volume restriction

3

liberal fluid management

Group Type ACTIVE_COMPARATOR

fluid management

Intervention Type PROCEDURE

liberal fluid management

Interventions

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fluid management

volume and sodium restriction

Intervention Type PROCEDURE

fluid management

volume restriction

Intervention Type PROCEDURE

fluid management

liberal fluid management

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* epidural anesthesia
* ASA I-III

Exclusion Criteria

* metastasized cancer
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Westphal, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology and Intensive Care, University Hospital Münster

Locations

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Raphaelsklinik

Münster, , Germany

Site Status

St. Franziskus-Hospital Münster

Münster, , Germany

Site Status

Department of Anesthesiology and Intensive Care, University Hospital Münster

Münster, , Germany

Site Status

Countries

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Germany

Other Identifiers

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02-Anast-05

Identifier Type: -

Identifier Source: org_study_id

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