NCT00076219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,124

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2003

Longer than P75 for phase_3

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2004

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

August 16, 2013

Completed
Last Updated

August 23, 2013

Status Verified

August 1, 2013

Enrollment Period

3.9 years

First QC Date

January 15, 2004

Results QC Date

June 12, 2013

Last Update Submit

August 16, 2013

Conditions

Acute Renal Failure

Keywords

Acute Renal FailureRenal Replacement Therapymulti-site randomization trialHemodialysisHemofiltrationCritical IllnessHemodiafiltration

Outcome Measures

Primary Outcomes (1)

  • 60-day All-cause Mortality

    60-day all-cause mortality

    60 days

Study Arms (2)

Intensive renal replacement therapy

EXPERIMENTAL

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

Less-intensive renal replacement therapy

ACTIVE COMPARATOR

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

Interventions

renal replacement therapyPROCEDURE

renal replacement therapy

Intensive renal replacement therapyLess-intensive renal replacement therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

No. Little Rock, Arkansas, 72114-1706, United States

Location

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

VA Medical Center, Augusta

Augusta, Georgia, 30904, United States

Location

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

VA Medical Center, Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113, United States

Location

VA Medical Center, St Louis

St Louis, Missouri, 63106, United States

Location

VA Western New York Healthcare System at Buffalo

Buffalo, New York, 14215, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157-1053, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Medical Center

Nashville, Tennessee, 37212-2637, United States

Location

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Related Publications (12)

  • VA/NIH Acute Renal Failure Trial Network; Palevsky PM, Zhang JH, O'Connor TZ, Chertow GM, Crowley ST, Choudhury D, Finkel K, Kellum JA, Paganini E, Schein RM, Smith MW, Swanson KM, Thompson BT, Vijayan A, Watnick S, Star RA, Peduzzi P. Intensity of renal support in critically ill patients with acute kidney injury. N Engl J Med. 2008 Jul 3;359(1):7-20. doi: 10.1056/NEJMoa0802639. Epub 2008 May 20.

    PMID: 18492867RESULT

  • Palevsky PM, O'Connor TZ, Chertow GM, Crowley ST, Zhang JH, Kellum JA; US Department of Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network. Intensity of renal replacement therapy in acute kidney injury: perspective from within the Acute Renal Failure Trial Network Study. Crit Care. 2009;13(4):310. doi: 10.1186/cc7901. Epub 2009 Aug 11.

    PMID: 19678919RESULT

  • Palevsky PM, O'Connor T, Zhang JH, Star RA, Smith MW. Design of the VA/NIH Acute Renal Failure Trial Network (ATN) Study: intensive versus conventional renal support in acute renal failure. Clin Trials. 2005;2(5):423-35. doi: 10.1191/1740774505cn116oa.

    PMID: 16317811RESULT

  • Johansen KL, Smith MW, Unruh ML, Siroka AM, O'Connor TZ, Palevsky PM; VA/NIH Acute Renal Failure Trial Network. Predictors of health utility among 60-day survivors of acute kidney injury in the Veterans Affairs/National Institutes of Health Acute Renal Failure Trial Network Study. Clin J Am Soc Nephrol. 2010 Aug;5(8):1366-72. doi: 10.2215/CJN.02570310. Epub 2010 May 27.

    PMID: 20507953RESULT

  • Joyce VR, Smith MW, Johansen KL, Unruh ML, Siroka AM, O'Connor TZ, Palevsky PM; Veteran Affairs/National Institutes of Health Acute Renal Failure Trial Network. Health-related quality of life as a predictor of mortality among survivors of AKI. Clin J Am Soc Nephrol. 2012 Jul;7(7):1063-70. doi: 10.2215/CJN.00450112. Epub 2012 May 17.

    PMID: 22595826RESULT

  • Zampieri FG, Serpa-Neto A, Wald R, Bellomo R, Bagshaw SM; STARRT-AKI and RENAL Investigators. Hierarchical endpoints in critical care: A post-hoc exploratory analysis of the standard versus accelerated initiation of renal-replacement therapy in acute kidney injury and the intensity of continuous renal-replacement therapy in critically ill patients trials. J Crit Care. 2024 Aug;82:154767. doi: 10.1016/j.jcrc.2024.154767. Epub 2024 Mar 11.

    PMID: 38461657DERIVED

  • Kwong YD, Liu KD, Hsu CY, Cooper B, Palevsky PM, Kellum JA, Johansen KL, Miaskowski C. Subgroups of Patients with Distinct Health Utility Profiles after AKI. Kidney360. 2023 Jul 1;4(7):881-889. doi: 10.34067/KID.0000000000000201. Epub 2023 Jun 26.

    PMID: 37357351DERIVED

  • Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3.

    PMID: 36416787DERIVED

  • Naorungroj T, Neto AS, Wang A, Gallagher M, Bellomo R. Renal outcomes according to renal replacement therapy modality and treatment protocol in the ATN and RENAL trials. Crit Care. 2022 Sep 6;26(1):269. doi: 10.1186/s13054-022-04151-5.

    PMID: 36068554DERIVED

  • Tsujimoto Y, Miki S, Shimada H, Tsujimoto H, Yasuda H, Kataoka Y, Fujii T. Non-pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2021 Sep 14;9(9):CD013330. doi: 10.1002/14651858.CD013330.pub2.

    PMID: 34519356DERIVED

  • Sharma S, Kelly YP, Palevsky PM, Waikar SS. Intensity of Renal Replacement Therapy and Duration of Mechanical Ventilation: Secondary Analysis of the Acute Renal Failure Trial Network Study. Chest. 2020 Oct;158(4):1473-1481. doi: 10.1016/j.chest.2020.05.542. Epub 2020 May 26.

    PMID: 32470389DERIVED

  • Ng YH, Ganta K, Davis H, Pankratz VS, Unruh M. Vascular Access Site for Renal Replacement Therapy in Acute Kidney Injury: A Post hoc Analysis of the ATN Study. Front Med (Lausanne). 2017 Apr 11;4:40. doi: 10.3389/fmed.2017.00040. eCollection 2017.

    PMID: 28443283DERIVED

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Paul M. Palevsky MD
Organization
VA Pittsburgh Healthcare System and University of Pittsburgh School of Medicine, Pittsburgh, PA
paul.palevsky@va.gov
410-360-3932

Study Officials

  • Paul M. Palevsky

    VA Pittsburgh Health Care System

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2004

First Posted

January 19, 2004

Study Start

October 1, 2003

Primary Completion

September 1, 2007

Study Completion

July 1, 2008

Last Updated

August 23, 2013

Results First Posted

August 16, 2013

Record last verified: 2013-08

Locations

US(22)