Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076219
Status:
COMPLETED
Last Update Posted:
2013-08-23
First Post:
2004-01-15
Brief Title:
Acute Renal Failure Trial Network ATN Study
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 530 - Intensive vs Conventional Renal Support in Acute Renal Failure
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATN
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 - iea 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
Detailed Description:
Primary Hypothesis An intensive management strategy for renal support in critically ill patients with acute renal failure decreases mortality as compared to less intensive 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 less intensive conventionally recommended management strategies for renal replacement therapy
Primary Outcomes 60-day all-cause mortality
Secondary Outcomes All-cause hospital mortality 1-year all cause mortality recovery of renal function duration of renal support dialysis-free days ICU and hospital length of stay ICU-and hospital-free days non-renal organ system failures organ-failure-free days and discharge to home not on dialysis
Study Abstract The optimal management of renal replacement therapy RRT in acute renal failure ARF is uncertain The VANIH 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 less intensive 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 mLkghour in the intensive management strategy arm and 20 mLkghour 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 developmentrecovery 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 44 months was selected to provide a power of 090 to detect a reduction in mortality from 55 to 45 with alpha005 assuming a dropoutloss-to-follow-up rate of 10
Study enrollment began in November 2003 and closed after 44 months on July 2 2007 Total enrollment was 1124 subjects Fewer than 3 of subjects withdrew from protocol therapy Follow-up for the primary study endpoint 60-day all-cause mortality concluded on August 31 2007 one-year follow-up will conclude in July 2008
A type of dialysis solution used in the study was under IND with No 67631 and granted by Center for Drug Evaluation and Research in FDA
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 less intensive conventionally recommended management strategies for renal replacement therapy
Primary Outcomes 60-day all-cause mortality
Secondary Outcomes All-cause hospital mortality 1-year all cause mortality recovery of renal function duration of renal support dialysis-free days ICU and hospital length of stay ICU-and hospital-free days non-renal organ system failures organ-failure-free days and discharge to home not on dialysis
Study Abstract The optimal management of renal replacement therapy RRT in acute renal failure ARF is uncertain The VANIH 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 less intensive 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 mLkghour in the intensive management strategy arm and 20 mLkghour 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 developmentrecovery 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 44 months was selected to provide a power of 090 to detect a reduction in mortality from 55 to 45 with alpha005 assuming a dropoutloss-to-follow-up rate of 10
Study enrollment began in November 2003 and closed after 44 months on July 2 2007 Total enrollment was 1124 subjects Fewer than 3 of subjects withdrew from protocol therapy Follow-up for the primary study endpoint 60-day all-cause mortality concluded on August 31 2007 one-year follow-up will conclude in July 2008
A type of dialysis solution used in the study was under IND with No 67631 and granted by Center for Drug Evaluation and Research in FDA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None