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| autoid | 65 |
| crg_id | CRG110500017 |
| titleoftrial | Intensive versus Conventional Renal Support in Acute Renal Failure |
| acronymnoftrial | VA/NIH Acute Renal Failure Trial Network (ATN) Study |
| website | http://www.ATNStudy.org |
| identificationno | NCT00076219 |
| leadprefix | Dr |
| leadsurname | Palevsky |
| leadgivennames | Paul |
| leadposition | Chief, Renal Section |
| leaddepartment | Medical Service |
| leadorganisation | VA Pittsburgh Healthcare System |
| leadaddress | University Drive, Pittsburgh, PA 15240, USA |
| leademail | palevsky@pitt.edu |
| leadphone | +1 412 688 6474 |
| leadfax | +1 412 688 6908 |
| leadsuffix | |
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| contactgivennames | |
| contactposition | |
| contactdepartment | |
| contactorganisation | |
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| funding | govt |
| otherfunding | |
| fundingnameofsponsors | US Department of Veterans Affairs Cooperative Studies Program; NIH/NIDDK |
| ethicsapproval | yes |
| studytype | randomised |
| studytype_other | |
| groupassignment | parallel |
| blinding_patients | no |
| blinding_investigators | no |
| blinding_outcomes | no |
| blinding_analysts | yes |
| proposedstart | |
| actualstart | 11/2003 |
| proposedcompletiondate | 11/2007 |
| actualcompletiondate | |
| multi_center_study | yes |
| numberofcentres | 21-25 |
| multi_national_study | no |
| countrycentres | USA |
| researchquestion | 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 to conventional management of renal
replacement therapy. |
| study_status_recruitment | ongoing |
| study_status_recruitment_follow | ongoing |
| healthcarecondition | Acute Renal Failure |
| intervention1 | 6-times per week hemodialysis in hemodynamically stable patients; 6-tiems per week SLED or CVVHDF with an effluent flow rate of 35 mL/kg/hour in hemodynamically unstable patients |
| intervention2 | 3-times per week hemodialysis in hemodynamically stable patients; 3-tiems per week SLED or CVVHDF with an effluent flow rate of 20 mL/kg/hour in hemodynamically unstable patients |
| intervention3 | |
| intervention4 | |
| participants_gender | both |
| participants_other | adults |
| age | at least 18 years of age |
| totalrecruitment | 1164 |
| inclusion | 1. ARF clinically consistent with a diagnosis of 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 (SOFA organ system score of at least 2) or the presence of sepsis 5. Age of at least 18 years 6. Informed consent |
| exclusion | 1. Baseline CKD defined by serum creatinine > 2 mg/dL (men) / 1.5 mg/dL (women)
2. ARF due to an etiology other than ATN 3. More than 72 hours since meeting BOTH of the following: Definition of ARF as specified in the inclusion criteria and a BUN > 100 mg/dL 4. More than 1 hemodialysis treatment or more than 24 hours of CRRT 5. History of kidney transplantation 6. Weight > 128.5 kg 7. Pregnancy 8. Prisoner 9. Non-candidacy for RRT 10. Not expected to survive 28-days due to underlying chronic medical condition 11. Moribund sate or CMO status 12. Participation in a concurrent interventional trial 13. Patient refusal 14. Physician refusal |
| primaryoutcomes | 60-day all cause mortality |
| secondaryoutcomes | Hospital mortality
1-year mortality Recovery of renal function by day 28 Cost effectiveness Exploratory outcomes Duration of renal support ICU length-of-stay Hospital length-of-stay Discharge to ?home? off of dialysis by day-60 SOFA Organ Failure Scores at days 1-14, 21and 28 |
| reference | 1. 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. |