Effect of Intraoperative Fluid Management on Morbidity | NCT00156338

Studies
Effect of Intraoperative Fluid Management on Morbidity

NCT00156338

Sponsor

University Hospital Muenster

Status

Completed

Last Update Posted

Jan 18, 2012Estimated

Enrollment

108Actual

Phase

Not Applicable

Conditions

Epidural Anesthesia

Interventions

fluid management
fluid management
fluid management

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2010Actual

First Submitted Date

Sep 8, 2005

First Submission Date that Met QC Criteria

Sep 8, 2005

First Posted Date

Sep 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2012

Last Update Posted Date

Jan 18, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
fluid management	Procedure	volume and sodium restriction	1
fluid management

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause Morbidity		one year

Secondary Outcomes

Measure	Description	Time Frame
Gastral and intestinal function		within the first 30 days after surgery
all cause Mortality		one year
Gastral and intestinal function

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

epidural anesthesia
ASA I-III

Exclusion Criteria:

metastasized cancer
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Westphal, MD	Department of Anesthesiology and Intensive Care, University Hospital Münster	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Raphaelsklinik		Münster		D-48143	Germany
St. Franziskus-Hospital Münster