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Investigator Access
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What's Available
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- Participant contact information: Names and contact information of participants recruited for the ATN
- Research data: Coded individual participant data that underlie the results reported in the primary publication (SAS, CSV, Excel, and text file formats)
- Biospecimens: Coded DNA, plasma, and serum samples from 965 participants
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Available Documentation
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Data dictionary
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Dates Data are Available
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Currently available, no end date
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Access Criteria
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Investigators associated with VA or non-VA nonprofit, academic, or research institutions can request access through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository. (Requires an account to access)
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Study Characteristics
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Objectives
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Primary Objective
- To determine if a strategy of intensive renal support decreases 60-day all-cause mortality in critically ill patients with acute renal failure as compared with conventional management of renal replacement therapy.
Secondary Objectives
- To determine if a strategy of intensive renal support for acute renal failure, as compared with conventional management of renal replacement therapy:
o Decreases all-cause hospital mortality
o Decreases 1-year all-cause mortality
o Increases the recovery of renal function
Tertiary Objectives
- To determine if intensive renal support for acute renal failure, as compared with conventional renal replacement therapy:
o Decreases the duration of renal support
o Decreases ICU length-of-stay
o Decreases hospital length-of-stay
o Increases the incidence of discharge to “home” off of dialysis
o Decreases the incidence and duration of non-renal organ failure
Economic Analysis
- To determine the costs associated with intensive renal support as compared with conventional renal replacement therapy for acute renal failure and to evaluate the health economic impact of intensive as compared with conventional management of renal replacement therapy.
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Era of Service
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All
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Population
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Patients within VA health care system (70.6% male) who are critically ill with acute renal failure due to acute tubular necrosis and require renal replacement therapy.
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Study Design
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Multi-center, prospective, randomized parallel-group trial
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Intervention
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- Experimental: Intensive renal replacement therapy.
o 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.
- Active Comparator: Less-intensive renal replacement therapy.
o 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.
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Time Period
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November 2003 – July 2008
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Setting
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National
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N
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1124 participants
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Response Rate
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Unconfirmed
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Recruitment Method
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4340 patients receiving care in the critical care units of the 27 participating VA and university-affiliated medical centers were screened during 3-years intake period.
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Compensation
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None
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Data Collected
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Primary Outcomes
- 60-day all-cause mortality
Secondary Outcomes
- All-cause hospital mortality
- 1-year all-cause mortality
- Recovery of renal function
Tertiary Outcomes
- Duration of renal support (dialysis-free days)
- ICU and hospital length of stay (ICU-and hospital-free days)
- Non-renal organ system failures (organ-failure-free days)
- Discharge to "home" not on dialysis
Economic Outcomes
- Renal replacement therapy-specific cost of care
- Global cost of care
- Patient utility
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Data Collection Methods
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- In-person questionnaires and physical exams at study visits
- Phone or mail follow-up questionnaires
- Laboratory reports
- Patient medical records
- Vital statistic registries
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Funding Sources
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- VA
- Department of Health and Human Services (HHS)
- National Institutes of Health (NIH)
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Investigators
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Paul M. Palevsky, MD
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Contact
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Study Chair & Primary Investigator: Paul M. Palevsky, MD, Paul.Palevsky@va.gov
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Selected Publications
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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. (PMCID: PMC1351394)
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. (PMCID: PMC2750132)
Overberger P, Pesacreta M, Palevsky PM for the VA/NIH Acute Renal Failure Trial Network. Management of renal replacement therapy in acute kidney injury: A survey of practitioner prescribing practices. Clinical Journal of the American Society of Nephrology 2007; 2:623-630. (PMCID: PMC2325917)
Crowley ST, Chertow GM, Vitale J, O’Connor T, Zhang J, Schein RMH, Choudhury D, Finkel K, Vijayan A, Paganini E, Palevsky PM for the VA/NIH Acute Renal Failure Trial Network Study Group. Lessons for successful study enrollment from the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study. Clinical Journal of the American Society of Nephrology 2008; 3:955-961. (PMCID: PMC2440269)
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More Information
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Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT00076219
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