Acute Renal Failure Trial Network (ATN) Study (ATN)
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| ClinicalTrials.gov Identifier: NCT00076219 |
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Recruitment Status :
Completed
First Posted : January 19, 2004
Results First Posted : August 16, 2013
Last Update Posted : August 23, 2013
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Sponsor:
US Department of Veterans Affairs
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Renal Failure | Procedure: renal replacement therapy | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1124 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure |
| Study Start Date : | October 2003 |
| Actual Primary Completion Date : | September 2007 |
| Actual Study Completion Date : | July 2008 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Procedure: renal replacement therapy
renal replacement therapy |
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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.
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Procedure: renal replacement therapy
renal replacement therapy |
Primary Outcome Measures :
- 60-day All-cause Mortality [ Time Frame: 60 days ]60-day all-cause mortality
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
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More than 72 hours since meeting both of the following conditions:
- Fulfillment of the definition of ARF; and
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076219
Show 22 Study Locations
Sponsors and Collaborators
US 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 |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | US Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00076219 History of Changes |
| Other Study ID Numbers: |
530 |
| First Posted: | January 19, 2004 Key Record Dates |
| Results First Posted: | August 16, 2013 |
| Last Update Posted: | August 23, 2013 |
| Last Verified: | August 2013 |
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
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Acute Renal Failure Renal Replacement Therapy multi-site randomization trial Hemodialysis |
Hemofiltration Critical Illness Hemodiafiltration |
Additional relevant MeSH terms:
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Renal Insufficiency Acute Kidney Injury Kidney Diseases Urologic Diseases |