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Renal Study Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Renal Study conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Renal Study Clinical research trials and Renal Study health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Renal Study. Renal Study Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Renal Study clinical trial. Human subjects often get the best healthcare available for their Renal Study condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Renal Study  Renal Study
Renal Study
For Condition: Acute Renal Failure
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK),Department of Veterans Affairs Cooperative Studies Program
Synopsis: ATN is a multi-center, prospective, randomized, parallel-group trial of an intensive strategy versus conventional strategy of renal replacement therapy for the treatment of acute renal failure (ARF) 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 and each patient will be actively followed for 60 days.
Details: Primary Hypothesis: An intensive management strategy for renal support in critically ill patients with acute renal failure decreases mortality as compared to conventionally recommended management strategies for renal replacement therapy. Secondary Hypotheses: An intensive management strategy for renal support in critically ill patients with acute renal failure will shorten the duration of ARF, decrease the incidence and duration of non-renal complications and is cost-effective as compared to conventionally recommended management strategies for renal replacement therapy. Primary Outcomes: 60-day all-cause mortality. Study Abstract: The optimal management of renal replacement therapy (RRT) in acute renal failure (ARF) is uncertain. The VA/NIH Acute Renal Failure Trial Network (ATN Study) is designed to test the hypothesis that a strategy of intensive renal support will decrease mortality in critically ill patients with ARF as compared to conventionally recommended management. In this multicenter, prospective trial, patients with ARF due to acute tubular necrosis will be randomized equally to intensive or conventional management strategies for RRT. In both arms, RRT will be initiated using the same criteria. Hemodynamically stable patients (SOFA cardiovascular score: 0-2) will receive intermittent hemodialysis (IHD) while hemodynamically unstable patients (SOFA cardiovascular score: 3-4) will be treated with continuous venovenous hemodiafiltration (CVVHDF) or sustained low-efficiency hemodialysis (SLED). Patients will convert between modalities of therapy as hemodynamic status changes over time. The intensity of therapy in IHD and SLED will vary between groups based on treatment frequency; with treatments provided 6-times per week in the intensive management strategy arm and 3-times per week in the conventional management strategy arm. In CVVHDF, intensity of therapy will vary based on effluent flow rate with a prescribed flow rate of 35 mL/kg/hour in the intensive management strategy arm and 20 mL/kg/hour in the conventional management strategy arm. Protocol therapy will be continued until renal function recovers or until day 28. The primary study end-point will be 60-day all-cause mortality. Other end-points will include hospital and 1-year mortality, recovery of renal function, duration of renal support, ICU and hospital length of stay, hospital discharge off of dialysis and development/recovery of non-renal organ failure. An economic analysis will be performed to assess the costs and relative cost effectiveness of the two strategies. The planned total enrollment of 1164 patients at 27 institutions over 3 years will provide a power of 0.90 to detect a reduction in mortality from 55% to 45% with a=0.05. Study enrollment began in November 2003.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 1164
Location and Contact Information:
West Los Angeles VA Healthcare Center *Recruiting*
Los Angeles, California, 90073
United States
Recruiting Jeffrey Kraut 310-268-3703
Washington University School of Medicine *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Anitha Vijayan 314-362-8293
University of Miami *Recruiting*
Miami, Florida, 33136
United States
Recruiting Gabriel Contreras 305-243-4691
Portland VAMC *Recruiting*
Portland, Oregon, 97207
United States
Recruiting Suzanne Watnick 503-220-8262
VA Tennessee Valley Healthcare System *Not yet recruiting*
Nashville, Tennessee, 37212-2637
United States
Not yet recruiting William Stone 615-327-5366
Hunter Holmes McGuire VAMC *Recruiting*
Richmond, Virginia, 23249
United States
Recruiting George Feldman 804-675-6901
VACT Healthcare System *Recruiting*
West Haven, Connecticut, 06516
United States
Recruiting Susan Crowley 203-932-5711
The Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Emil Paganini 216-444-5792
VA Pittsburgh Healthcare System *Recruiting*
Pittsburgh, Pennsylvania, 15240
United States
Recruiting Nabeel Aslam 412-688-6000
Richard L. Roudebush VAMC *Recruiting*
Indianapolis, Indiana, 46202
United States
Recruiting Robert Bacallao 317-278-0471
Wake Forest University School of Medicine *Recruiting*
Winston Salem, North Carolina, 27157-1053
United States
Recruiting Michael Rocco 336-716-2097
VA North Texas Healthcare System *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Devasmita Dev 214-857-1593
Massachusetts General Hospital *Not yet recruiting*
Boston, Massachusetts, 02114
United States
Not yet recruiting John Niles 617-726-3446
San Juan VAMC *Recruiting*
San Juan, , 00921-3201
Puerto Rico
Recruiting Carlos Rosado-Rodriguez (787) 641-7582
MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Andrew Shaw 713-792-2146
New Orleans VAMC *Recruiting*
New Orleans, Louisiana, 70146
United States
Recruiting Vecihi Batuman 504-588-5346
Johns Hopkins University School of Medicine *Recruiting*
Baltimore, Maryland, 21205
United States
Recruiting Hamid Rabb 410-502-1556
Central Arkansas Veterans Healthcare System *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting Mary Shaver 501-686-5295
San Francisco VAMC *Not yet recruiting*
San Francisco, California, 94121
United States
Not yet recruiting Kirsten Johansen 415-221-4810
University of California, San Francisco *Not yet recruiting*
San Francisco, California, 94118-1211
United States
Not yet recruiting Glenn Chertow 415-476-2172
VA Western New York Healthcare System *Recruiting*
Buffalo, New York, 14215
United States
Recruiting James Lohr 716-834-9200
University of Texas Medical School @ Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting Kevin Finkel 713-500-6873
VA San Diego Healthcare System *Recruiting*
San Diego, California, 92161
United States
Recruiting Francis Gabbai 858-552-8585
Houston VAMC *Recruiting*
Houston, Texas, 77030-4298
United States
Recruiting George Dolson 713-794-7244
Miami VAMC *Recruiting*
Miami, Florida, 33125-1693
United States
Recruiting Roland Schein 305-324-3153
University of Pittsburgh Medical Center *Recruiting*
Pittsburgh, Pennsylvania, 15261
United States
Recruiting Nabeel Aslam 412-647-2561
Puget Sound Healthcare System *Recruiting*
Seattle, Washington, 98108-1597
United States
Recruiting Dennis Andress 206-277-3282
VA Ann Arbor Healthcare System *Recruiting*
Ann Arbor, Michigan, 48105
United States
Recruiting Eric Young 734-769-7100
Additional Information:
Study ID Numbers: 530;
Study Start Date: July 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076219
Other Acute Renal Failure Studies:
1. Renal Study
2. Phase I Study of Alpha-Melanocyte Stimulating Hormone in Patients with Acute Renal Failure
Related Studies:
Other Acute Renal Failure Clinical Trials
Other Florida Clinical Trials
Other Miami Clinical Trials
Renal Study
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