Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000044022
Ethics application status
Approved
Date submitted
14/01/2010
Date registered
14/11/2005
Date last updated
10/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intensive versus Conventional Renal Support in Acute Renal Failure
Scientific title
In critically ill patients with acute renal failure does a strategy of intensive renal replacement therapy as compared to a strategy of less-intensive renal replacement therapy decrease all-cause mortality at 60 days
Secondary ID [1] 982 0
ClinicalTrials.gov NCT00076219
Universal Trial Number (UTN)
Trial acronym
ATN Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Renal Failure 243643 0
Condition category
Condition code
Renal and Urogenital 256702 256702 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive renal replacement therapy defined as: Daily (except Sunday) intermittent hemodialysis when hemodynamically stable and
Continuous venovenous hemodiafiltration at 35 mL/kg per hour or daily (except Sunday) sustained low-efficiency dialysis when hemodynamically unstable
Duration of intervention: Up to 28 days or until recovery of kidney function, withdrawal of life support, death or discharge from acute care
Intervention code [1] 255809 0
Treatment: Other
Comparator / control treatment
Less-intensive renal replacement therapy defined as: Evenry-other day (except Sunday) intermittent hemodialysis when hemodynamically stable and
Continuous venovenous hemodiafiltration at 20 mL/kg per hour or every-other day (except Sunday) sustained low-efficiency dialysis when hemodynamically unstable
Control group
Active

Outcomes
Primary outcome [1] 257589 0
All-cause mortality as assessed from medical records
Timepoint [1] 257589 0
60 days following randomization
Secondary outcome [1] 262851 0
Recovery of renal function defined as a measured creatinine clearance of > 20 mL/min
Timepoint [1] 262851 0
28 days after randomization
Secondary outcome [2] 262852 0
All-cause in-hosptial mortality assessed from hospital medical records
Timepoint [2] 262852 0
60 days following randomisation
Secondary outcome [3] 262853 0
All-cause mortality assessed from follow-up telephone interview and/or vital status registry
Timepoint [3] 262853 0
1 year following randomization

Eligibility
Key inclusion criteria
1. Acute renal failure (ARF) clinically consistent with a diagnosis of acute tubular necrosis (ATN), defined as: clinical setting of acute ischemic or nephrotoxic injury; and oliguria (average urine output < 20 mL/hr) for > 24 hours or an increase in serum creatinine of at least 2.0 mg/dL (men)/1.5 mg/dL (women) over a period of no more than 4 days

2. Plan for renal replacement therapy

3. Receiving care in critical care unit

4. At least one non-renal organ failure (Sequential Organ Function Assessment organ system score of at least 2) or the presence of sepsis

5. Age of at least 18 years

6. Informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Baseline chronic kidney disease (CKD) defined by serum creatinine > 2 mg/dL (men) / 1.5 mg/dL (women)

2. Acute renal failure (ARF) due to an etiology other than acute tubular necrosis (ATN)

3. More than 72 hours since meeting BOTH of the following: Definition of ARF as specified in the inclusion criteria and a blood urea nitrogen (BUN) > 100 mg/dL

4. More than 1 hemodialysis treatment or more than 24 hours of continuous renal replacement therapy (CRRT)

5. History of kidney transplantation

6. Weight > 128.5 kg

7. Pregnancy

8. Prisoner

9. Non-candidacy for renal replacement therapy (RRT)

10. Not expected to survive 28-days due to underlying chronic medical condition

11. Moribund sate or comfert measures only (CMO) status

12. Participation in a concurrent interventional trial

13. Patient refusal

14. Physician refusal

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/11/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1164
Accrual to date
Final
Recruitment outside Australia
Country [1] 1993 0
United States of America
State/province [1] 1993 0

Funding & Sponsors
Funding source category [1] 256299 0
Government body
Name [1] 256299 0
US Department of Veterans Affairs
Country [1] 256299 0
United States of America
Funding source category [2] 256300 0
Government body
Name [2] 256300 0
National Institutes of Health
Country [2] 256300 0
United States of America
Primary sponsor type
Government body
Name
US Department of Veterans Affairs Cooperative Studies Program
Address
1722 I St., NW
Washington, DC 20006
Country
United States of America
Secondary sponsor category [1] 251621 0
Government body
Name [1] 251621 0
National Institutes of Health
Address [1] 251621 0
6707 Democracy Boulevard
Bethesda, MD 20892
Country [1] 251621 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258386 0
Cooperative Studies Program Human Rights Committee
Ethics committee address [1] 258386 0
Ethics committee country [1] 258386 0
United States of America
Date submitted for ethics approval [1] 258386 0
Approval date [1] 258386 0
16/07/2002
Ethics approval number [1] 258386 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30131 0
Address 30131 0
Country 30131 0
Phone 30131 0
Fax 30131 0
Email 30131 0
Contact person for public queries
Name 13378 0
Dr, Paul Palevsky
Address 13378 0
Chief, Renal Section, Medical Service, VA Pittsburgh Healthcare System, University Drive, Pittsburgh, PA 15240, USA
Country 13378 0
United States of America
Phone 13378 0
+1 412 360-3932
Fax 13378 0
Email 13378 0
[email protected]
Contact person for scientific queries
Name 4306 0
Dr. Paul Palevsky
Address 4306 0
Chief, Renal Section, Medical Service, VA Pittsburgh Healthcare System, University Drive, Pittsburgh, PA 15240, USA
Country 4306 0
United States of America
Phone 4306 0
+1 412 360-3932
Fax 4306 0
Email 4306 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.