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

Acute Renal Failure Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322530
• Other study ID #: HD-Dialysis-2006
• Status: Completed
• Phase: N/A
• First received: May 4, 2006
• Last updated: August 23, 2012
• Start date: April 2006
• Est. completion date: February 2009

Study information

• Verified date: August 2012
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Critical Illness
• Dialysis
• Renal Insufficiency

Intervention

Procedure:
• Renal replacement therapy
ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED

Locations

Country	Name	City	State
Germany	Division of Nephrology, University of Heidelberg	Heidelberg	Baden-Wurttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death		90 days	No
Secondary	costs		in hospital	No
Secondary	Restitution of renal function		90 days	No
Secondary	days on ICU		in hospital	No
Secondary	hemodynamic stability		in hospital	No
Secondary	dialysis efficiency		in hospital	No