Back to resultsComparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure (rescue)
Primary Purpose
Dialysis, Acute Renal Failure
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Renal replacement therapy
Sponsored by
About this trial
This is an interventional treatment trial for Dialysis
Eligibility 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
Sites / Locations
- Division of Nephrology, University of Heidelberg
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
SLED
CVVHD
Arm Description
Outcomes
Primary Outcome Measures
Death
Secondary Outcome Measures
costs
Restitution of renal function
days on ICU
hemodynamic stability
dialysis efficiency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00322530
Brief Title
Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure
Acronym
rescue
Official Title
Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure on the Intensive Care Unit
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis, Acute Renal Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SLED
Arm Type
Active Comparator
Arm Title
CVVHD
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Renal replacement therapy
Other Intervention Name(s)
sustained low efficiency dialysis (SLED), continous veno-venous hemodiafiltration (CVVHD)
Intervention Description
ICU patients with acute renal failure were prospectively randomized to either CVVHD or SLED
Primary Outcome Measure Information:
Title
Death
Time Frame
90 days
Secondary Outcome Measure Information:
Title
costs
Time Frame
in hospital
Title
Restitution of renal function
Time Frame
90 days
Title
days on ICU
Time Frame
in hospital
Title
hemodynamic stability
Time Frame
in hospital
Title
dialysis efficiency
Time Frame
in hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedat Schwenger, MD
Organizational Affiliation
Division of Nephrology, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Nephrology, University of Heidelberg
City
Heidelberg
State/Province
Baden-Wurttemberg
ZIP/Postal Code
69120
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
34519356
Citation
Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.
Results Reference
derived
PubMed Identifier
22839577
Citation
Schwenger V, Weigand MA, Hoffmann O, Dikow R, Kihm LP, Seckinger J, Miftari N, Schaier M, Hofer S, Haar C, Nawroth PP, Zeier M, Martin E, Morath C. Sustained low efficiency dialysis using a single-pass batch system in acute kidney injury - a randomized interventional trial: the REnal Replacement Therapy Study in Intensive Care Unit PatiEnts. Crit Care. 2012 Jul 27;16(4):R140. doi: 10.1186/cc11445. Erratum In: Crit Care. 2012;16(5):451.
Results Reference
derived
Learn more about this trial
Comparison of Dialysis Strategies in Critically Ill Patients With Acute Renal Failure
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