Acute Renal Failure Trial Network (ATN) Study
This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00076219
First received: January 15, 2004
Last updated: June 5, 2013
Last verified: June 2013
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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 |
Resource links provided by NLM:
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
|
Show Detailed Description 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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076219
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Hide Study LocationsLocations
| United States, Arkansas | |
| Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock | |
| No. Little Rock, Arkansas, United States, 72114-1706 | |
| United States, California | |
| VA Medical Center, San Francisco | |
| San Francisco, California, United States, 94121 | |
| VA Greater Los Angeles Healthcare System, West LA | |
| West Los Angeles, California, United States, 90073 | |
| United States, Colorado | |
| VA Eastern Colorado Health Care System, Denver | |
| Denver, Colorado, United States, 80220 | |
| United States, Connecticut | |
| VA Connecticut Health Care System (West Haven) | |
| West Haven, Connecticut, United States, 06516 | |
| United States, Florida | |
| VA Medical Center, Miami | |
| Miami, Florida, United States, 33125 | |
| United States, Georgia | |
| VA Medical Center, Augusta | |
| Augusta, Georgia, United States, 30904 | |
| United States, Indiana | |
| Richard Roudebush VA Medical Center, Indianapolis | |
| Indianapolis, Indiana, United States, 46202-2884 | |
| United States, Maryland | |
| VA Maryland Health Care System, Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| VA Medical Center, Jamaica Plain Campus | |
| Boston, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| VA Ann Arbor Healthcare System | |
| Ann Arbor, Michigan, United States, 48113 | |
| United States, Missouri | |
| VA Medical Center, St Louis | |
| St Louis, Missouri, United States, 63106 | |
| United States, New York | |
| VA Western New York Healthcare System at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| United States, North Carolina | |
| Wake Forest University School of Medicine | |
| Winston-Salem, North Carolina, United States, 27157-1053 | |
| United States, Ohio | |
| VA Medical Center, Cleveland | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| VA Medical Center, Portland | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| VA Pittsburgh Health Care System | |
| Pittsburgh, Pennsylvania, United States, 15240 | |
| United States, Tennessee | |
| VA Medical Center | |
| Nashville, Tennessee, United States, 37212-2637 | |
| United States, Texas | |
| VA North Texas Health Care System, Dallas | |
| Dallas, Texas, United States, 75216 | |
| Michael E. DeBakey VA Medical Center (152) | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| Hunter Holmes McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
| United States, Washington | |
| VA Puget Sound Health Care System, Seattle | |
| Seattle, Washington, United States, 98108 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Paul M. Palevsky | VA Pittsburgh Health Care System |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00076219 History of Changes |
| Other Study ID Numbers: | 530 |
| Study First Received: | January 15, 2004 |
| Last Updated: | June 5, 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 June 17, 2013