None listed
Conditions
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.
Interventions
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
Sponsors
US Department of Veterans Affairs Cooperative Studies Program
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed