Acute Renal FailurePhase 3ATNNCT00076219
Acute Renal Failure Trial Network (ATN) Study
A Phase 3 study testing renal replacement therapy in people with Acute Renal Failure, run by US Department of Veterans Affairs at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- renal replacement therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,124 participants
- Where
- 22 sitesUnited States
- Study dates
- Oct 2003to Jul 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, 48113
VA Medical Center, Augusta
Augusta, Georgia, 30904
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884
VA Medical Center, Miami
Miami, Florida, 33125
VA Medical Center
Nashville, Tennessee, 37212-2637
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, 72114-1706
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240
VA Medical Center, Portland
Portland, Oregon, 97201
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
VA Medical Center, San Francisco
San Francisco, California, 94121
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
VA Medical Center, St Louis
St Louis, Missouri, 63106
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, 90073
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1053
About this study
Official title: CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
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.
Read the 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 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 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 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 44 months was selected to provide a power of 0.90 to detect a reduction in mortality from 55% to 45% with alpha=0.05 assuming a dropout/loss-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. 67,631 and granted by Center for Drug Evaluation and Research in FDA.
- Conditions
- Acute Renal Failure
- Being tested
- renal replacement therapy
- Keywords
- Acute Renal Failure, Renal Replacement Therapy, multi-site randomization trial, Hemodialysis, Hemofiltration, Critical Illness, Hemodiafiltration
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal replacement therapyProcedure or surgery
renal replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: renal replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
60-day All-cause Mortality
60-day all-cause mortality
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2004 (estimated)
- Study startOct 2003
- Primary completionSep 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,124 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul M. Palevsky, Study chair, VA Pittsburgh Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076219
- Sponsor's protocol ID
- 530
- Acronym
- ATN
- Status last verified
- Aug 2013
- First submitted
- 15 Jan 2004
- Last updated
- 23 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 18492867Palevsky 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.
PubMed 19678919Palevsky 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.
PubMed 16317811Johansen 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.
PubMed 20507953Joyce 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.
PubMed 22595826Zampieri 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.
PubMed 38461657Kwong 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.
PubMed 37357351Fayad 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.
PubMed 36416787Naorungroj 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.
PubMed 36068554Tsujimoto 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.
PubMed 34519356Sharma 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.
PubMed 32470389Ng 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.
PubMed 28443283
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #530 - Intensive vs. Conventional Renal Support in Acute Renal Failure
- ClinicalTrials.gov ID
- NCT00076219
- Acronym / sponsor ID
- ATN / 530
- Conditions
- Acute Renal Failure
- Keywords
- Acute Renal Failure, Renal Replacement Therapy, multi-site randomization trial, Hemodialysis, Hemofiltration, Critical Illness, Hemodiafiltration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,124 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Oct 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 19 Jan 2004 (estimated)
- Results
- Posted 16 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 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 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 44 months was selected to provide a power of 0.90 to detect a reduction in mortality from 55% to 45% with alpha=0.05 assuming a dropout/loss-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. 67,631 and granted by Center for Drug Evaluation and Research in FDA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive renal replacement therapy | Experimental | Procedure: renal replacement therapyIn 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. |
| Less-intensive renal replacement therapy | Active comparator | Procedure: renal replacement therapyIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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:
- More than 1 hemodialysis treatment or more than 24 hours since starting continuous renal replacement therapy
- Prior kidney transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| renal replacement therapyrenal replacement therapy | Procedure or surgery | Intensive renal replacement therapy, Less-intensive renal replacement therapy |
Primary outcome
60-day All-cause Mortality
Time frame: 60 days
60-day all-cause mortality
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18492867VA/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.
- Results publication: PubMed 19678919Palevsky 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.
- Results publication: PubMed 16317811Palevsky 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.
- Results publication: PubMed 20507953Johansen 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.
- Results publication: PubMed 22595826Joyce 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.
- Derived from this study: PubMed 38461657Zampieri 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.
- Derived from this study: PubMed 37357351Kwong 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.
- Derived from this study: PubMed 36416787Fayad 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.
- Derived from this study: PubMed 36068554Naorungroj 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.
- Derived from this study: PubMed 34519356Tsujimoto 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.
- Derived from this study: PubMed 32470389Sharma 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.
- Derived from this study: PubMed 28443283Ng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul M. Palevsky study chair
VA Pittsburgh Health Care System
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing renal replacement therapy in people with Acute Renal Failure, run by US Department of Veterans Affairs at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
60-day All-cause Mortality (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00076219, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2013.