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

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ClinicalTrials.gov Identifier: NCT00322530
Recruitment Status : Completed
First Posted : May 8, 2006
Last Update Posted : August 24, 2012
Sponsor:
Information provided by (Responsible Party):
Vedat Schwenger M.D, University of Heidelberg

Brief Summary:
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 or disease Intervention/treatment Phase
Dialysis Acute Renal Failure Procedure: Renal replacement therapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit
Study Start Date : April 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

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)



Primary Outcome Measures :
  1. Death [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. costs [ Time Frame: in hospital ]
  2. Restitution of renal function [ Time Frame: 90 days ]
  3. days on ICU [ Time Frame: in hospital ]
  4. hemodynamic stability [ Time Frame: in hospital ]
  5. dialysis efficiency [ Time Frame: in hospital ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 8, 2006    Key Record Dates
Last Update Posted: August 24, 2012
Last Verified: August 2012

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