ANZCTR - Registration

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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]

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

Condition category

Condition code

Renal and Urogenital

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]

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]

All-cause mortality as assessed from medical records

Timepoint [1]

60 days following randomization

Secondary outcome [1]

Recovery of renal function defined as a measured creatinine clearance of > 20 mL/min

Timepoint [1]

28 days after randomization

Secondary outcome [2]

All-cause in-hosptial mortality assessed from hospital medical records

Timepoint [2]

60 days following randomisation

Secondary outcome [3]

All-cause mortality assessed from follow-up telephone interview and/or vital status registry

Timepoint [3]

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?

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]

United States of America

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

US Department of Veterans Affairs

Address [1]

1722 I St., NW
Washington, DC 20006

Country [1]

United States of America

Funding source category [2]

Government body

Name [2]

National Institutes of Health

Address [2]

6707 Democracy Boulevard
Bethesda, MD 20892

Country [2]

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]

Government body

Name [1]

National Institutes of Health

Address [1]

6707 Democracy Boulevard
Bethesda, MD 20892

Country [1]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Cooperative Studies Program Human Rights Committee

Ethics committee address [1]

Cooperative Studies Program Coordinating Center
VA Connecticut Healthcare System
950 Campbell Avenue
West Haven, CT  06516

Ethics committee country [1]

United States of America

Date submitted for ethics approval [1]

Approval date [1]

16/07/2002

Ethics approval number [1]

Summary

Brief summary

The Acute Renal Failure Trial Network (ATN) Study is a clinical research study that is jointly sponsored by the Department of Veterans Affairs and the National Institutes of Health in order to determine if an increased dose of dialysis will decrease mortality rates in patients with acute renal failure (ARF).

The ATN Study is being conducted using a network of VA and non-VA medical centers across the United States. The study is comparing two strategies for the management of renal replacement therapy in critically ill patients with ARF. Both treatment strategies employ both conventional intermittent hemodialysis in patients whose blood pressure is stable and either sustained low-efficiency dialysis (SLED) or continuous renal replacement therapy (CRRT) in patients who are hemodynamically unstable. In one strategy, intermittent hemodialysis and SLED are provided three-times per week and CRRT is dosed to provide a clearance of approximately 20 mL/kg/hour. In the other treatment arm, intermittent hemodialysis and SLED are provided six-times per week and CRRT is dosed to provide a clearance of approximately 35 mL/kg/hour.

The ATN study began enrolling patients in November 2003 and closed after 44 months on July 2, 2007. The total enrollment was 1124 subjects. All-cause mortality was 53.6% with intensive therapy and 51.5% with less-intensive therapy (odds ratio, 1.09; 95% confidence interval, 0.86 to 1.40; P = 0.47). There was no significant difference between the two groups in the duration of renal replacement therapy or the rate of recovery of kidney function or nonrenal organ failure.

Trial website

http://www.ATNStudy.org

Trial related presentations / publications

1. Palevsky PM, O'Connor T, Zhang JH, Star RA, Smith MW for the VA/NIH Acute Renal Failure Trial Network. Design of the VA/NIH Acute Renal Failure Trial Network (ATN) study: Intensive versus conventional renal support in acute renal failure.  Clinical Trials 2005; 2:423-435.
2. Palevsky PM, Zhang JH, O’Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RMH, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P for the VA/NIH Acute Renal Failure Trial Network. Intensity of renal support critically ill patients with acute kidney injury. New England Journal of Medicine 2008; 359:7-20.
3. Palevsky PM, O’Connor TZ, Chertow GM, Crowley ST, Zhang JH, Kellum JA for the VA/NIH Acute Renal Failure Trial Network.  Intensity of renal replacement therapy in acute kidney injury: Prospective from within the Acute Renal Failure Trial Network Study. Critical Care 2009; 13:310.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr, Paul Palevsky

Address

Chief, Renal Section, Medical Service, VA Pittsburgh Healthcare System, University Drive, Pittsburgh, PA 15240, USA

Country

United States of America

Phone

+1 412 360-3932

Fax

palevsky@pitt.edu

Contact person for scientific queries

Name

Dr. Paul Palevsky

Address

Chief, Renal Section, Medical Service, VA Pittsburgh Healthcare System, University Drive, Pittsburgh, PA 15240, USA

Country

United States of America

Phone

+1 412 360-3932

Fax

palevsky@pitt.edu

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

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No additional documents have been identified.

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