Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure (rescue)

August 23, 2012 updated by: Vedat Schwenger M.D, Heidelberg University

Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit

The goal of the present study is the comparison of different dialysis strategies in critically ill patients with acute renal failure on the intensive care unit. Patients are treated with either continuous dialysis or hemofiltration. Outcome measures are death, restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of the present study is the comparison of different renal replacement strategies in critically ill patients with acute renal failure on the intensive care unit. In a prospectively randomized clinical study patients are treated with either continuous dialysis (SLED) or continuous hemofiltration (CVVHD). 200 patients should be included in the study (n=100 each). The primary outcome is death at ICU, secondary outcome measures are restitution of renal function, days on ICU, hemodynamic stability, dialysis efficiency.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Division of Nephrology, University of Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18 years or older
  • Written informed consent
  • No pre-existing dialysis dependency

Exclusion Criteria:

  • Minors / children
  • No consent
  • Severe electrolyte disturbances which necessitates special dialysis therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SLED
Procedure: Renal replacement therapy
ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED
Other Names:
  • sustained low efficiency dialysis (SLED)
  • continous veno-venous hemodiafiltration (CVVHD)
Active Comparator: CVVHD
Procedure: Renal replacement therapy
ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED
Other Names:
  • sustained low efficiency dialysis (SLED)
  • continous veno-venous hemodiafiltration (CVVHD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
costs
Time Frame: in hospital
in hospital
Restitution of renal function
Time Frame: 90 days
90 days
days on ICU
Time Frame: in hospital
in hospital
hemodynamic stability
Time Frame: in hospital
in hospital
dialysis efficiency
Time Frame: in hospital
in hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heidelberg University

Investigators

  • Principal Investigator: Vedat Schwenger, MD, Division of Nephrology, University of Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

May 4, 2006

First Submitted That Met QC Criteria

May 4, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Estimate)

August 24, 2012

Last Update Submitted That Met QC Criteria

August 23, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-Dialysis-2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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