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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vedat Schwenger M.D, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00322530
First received: May 4, 2006
Last updated: August 23, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Dialysis
Acute Renal Failure
Procedure: Renal replacement therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Death [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • costs [ Time Frame: in hospital ] [ Designated as safety issue: No ]
  • Restitution of renal function [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • days on ICU [ Time Frame: in hospital ] [ Designated as safety issue: No ]
  • hemodynamic stability [ Time Frame: in hospital ] [ Designated as safety issue: No ]
  • dialysis efficiency [ Time Frame: in hospital ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: April 2006
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322530

Locations
Germany
Division of Nephrology, University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Vedat Schwenger, MD Division of Nephrology, University of Heidelberg
  More Information

No publications provided by Heidelberg University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vedat Schwenger M.D, Prof. Dr. med., University of Heidelberg
ClinicalTrials.gov Identifier: NCT00322530     History of Changes
Other Study ID Numbers: HD-Dialysis-2006
Study First Received: May 4, 2006
Last Updated: August 23, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Acute Kidney Injury
Critical Illness
Renal Insufficiency
Disease Attributes
Kidney Diseases
Pathologic Processes
Urologic Diseases

ClinicalTrials.gov processed this record on November 27, 2014