Heart Failure and Peritoneal Ultrafiltration

This study has been terminated.

(Enrollment)

Sponsor:

Information provided by:

Baxter Healthcare Corporation

ClinicalTrials.gov Identifier:

NCT00368641

First received: August 23, 2006

Last updated: April 30, 2009

Last verified: April 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

August 23, 2006

Last Updated Date

April 30, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

All-Cause Hospitalization (Unadjusted) [ Time Frame: 6 to 24 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00368641 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Heart Failure and Peritoneal Ultrafiltration

Official Title ^ICMJE

Treatment-Resistant Heart Failure (HF) and Peritoneal Ultrafiltration (PUF): A Randomized Prospective Trial of Standard Care Versus Standard Care With Peritoneal Ultrafiltration in Patients With Treatment-Resistant Severe Heart Failure

Brief Summary

The objective of the study is to determine if the addition of peritoneal ultrafiltration to standard therapy in treatment-resistant severe heart failure patients will improve fluid balance and functional capacity such that they will spend less time in the hospital and have an improved ambulatory quality of life in comparison to patients who remain on standard therapy alone.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Congestive Heart Failure

Intervention ^ICMJE

Drug: Extraneal

Periotneal Dialysis

Study Arm (s)

Experimental: Intervention
peritoneal dialysis

Intervention: Drug: Extraneal
No Intervention: Standard of Care

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2008

Primary Completion Date

April 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults with congestive heart failure (CHF) who remain fluid overloaded despite standard treatment.

Exclusion Criteria:

Patients who have reversible CHF or have diseases or conditions that would contraindicate the use of peritoneal dialysis.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Belgium, Canada

Administrative Information

NCT Number ^ICMJE

NCT00368641

Other Study ID Numbers ^ICMJE

25885

Has Data Monitoring Committee

Responsible Party

Bruce Culleton, Sr. Medical Director, Baxter Healthcare Corporation

Study Sponsor ^ICMJE

Baxter Healthcare Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Baxter Healthcare Corporation

Information Provided By

Baxter Healthcare Corporation

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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