Acute Renal Failure Trial Network (ATN) Study - Full Text View

Purpose

This is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy vs conventional strategy of renal replacement therapy for the treatment of acute renal failure secondary to acute tubular necrosis in critically ill patients. The primary hypothesis is that the intensive strategy will reduce 60-day all cause mortality by 10% compared to the conventional strategy - i.e.,a reduction from 55% in the conventional arm to 45% in the intensive arm. Secondary outcomes are 60-day in-hospital all-cause mortality, 1-year all cause mortality, and recovery of renal function by day 28. The study will recruit 1164 patients over a period of 3 years, 8 months and each patient will be actively followed for 60 days.

Condition	Intervention	Phase
Acute Renal Failure	Procedure: renal replacement therapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:

60-day All-cause Mortality [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
60-day all-cause mortality


Enrollment:	1124
Study Start Date:	October 2003
Study Completion Date:	July 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intensive renal replacement therapy In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.	Procedure: renal replacement therapy renal replacement therapy
Active Comparator: Less-intensive renal replacement therapy In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.	Procedure: renal replacement therapy renal replacement therapy

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Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Acute renal failure clinically consistent with a diagnosis of acute tubular necrosis
Plan for renal replacement therapy by clinical team
Receiving care in a critical care unit
One non-renal organ failure or sepsis
Age 18 or older
Patient or surrogate provides informed consent

Exclusion Criteria:

Baseline serum creatinine > 2 mg/dL (177 mol/L) in males, > 1.5 mg/dL (133 mol/L) in females
Acute renal failure clinically believed to be due to an etiology other than acute tubular necrosis
More than 72 hours since meeting both of the following conditions:
1. Fulfillment of the definition of ARF; and
2. BUN > 100 mg/dL (36 mmol/L)
More than 1 hemodialysis treatment or more than 24 hours since starting continuous renal replacement therapy
Prior kidney transplant
Pregnancy
Prisoner
Weight > 128.5 kg
Non-candidacy for renal replacement therapy
Moribund state
Patient not expected to survive 28 days because of underlying terminal chronic medical condition
Comfort-measures-only status
Participation in a concurrent interventional study
Patient/surrogate refusal
Physician refusal

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00076219

Show 22 Study Locations

Sponsors and Collaborators

Department of Veterans Affairs

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators


Study Chair:	Paul M. Palevsky	VA Pittsburgh Health Care System

More Information

Publications:

VA/NIH Acute Renal Failure Trial Network, Palevsky PM, Zhang JH, O'Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RM, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P. Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med. 2008 Jul 3;359(1):7-20. doi: 10.1056/NEJMoa0802639. Epub 2008 May 20. Erratum in: N Engl J Med. 2009 Dec 10;361(24):2391.

Palevsky PM, O'Connor TZ, Chertow GM, Crowley ST, Zhang JH, Kellum JA; US Department of Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network. Intensity of renal replacement therapy in acute kidney injury: perspective from within the Acute Renal Failure Trial Network Study. Crit Care. 2009;13(4):310. doi: 10.1186/cc7901. Epub 2009 Aug 11.

Palevsky PM, O'Connor T, Zhang JH, Star RA, Smith MW. Design of the VA/NIH Acute Renal Failure Trial Network (ATN) Study: intensive versus conventional renal support in acute renal failure. Clin Trials. 2005;2(5):423-35.

Johansen KL, Smith MW, Unruh ML, Siroka AM, O'Connor TZ, Palevsky PM; VA/NIH Acute Renal Failure Trial Network. Predictors of health utility among 60-day survivors of acute kidney injury in the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study. Clin J Am Soc Nephrol. 2010 Aug;5(8):1366-72. doi: 10.2215/CJN.02570310. Epub 2010 May 27.

Joyce VR, Smith MW, Johansen KL, Unruh ML, Siroka AM, O'Connor TZ, Palevsky PM; Veteran Affairs/National Institutes of Health Acute Renal Failure Trial Network. Health-related quality of life as a predictor of mortality among survivors of AKI. Clin J Am Soc Nephrol. 2012 Jul;7(7):1063-70. doi: 10.2215/CJN.00450112. Epub 2012 May 17.


Responsible Party:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00076219 History of Changes
Other Study ID Numbers:	530
Study First Received:	January 15, 2004
Results First Received:	June 12, 2013
Last Updated:	August 16, 2013
Health Authority:	United States: Federal Government

Keywords provided by Department of Veterans Affairs:


Acute Renal Failure Renal Replacement Therapy multi-site randomization trial Hemodialysis	Hemofiltration Critical Illness Hemodiafiltration

Additional relevant MeSH terms:


Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases

ClinicalTrials.gov processed this record on February 26, 2015