Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)
STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)
1 other identifier
interventional
3,019
14 countries
89
Brief Summary
The objectives of this trial are to determine whether, in critically ill patients with severe acute kidney injury (AKI), randomization to accelerated initiation of renal replacement therapy (RRT), compared to standard initiation, leads to:
- 1.Improved survival (primary outcome); and
- 2.Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
89 active sites
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
First Submitted
Initial submission to the registry
September 29, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedResults Posted
Study results publicly available
October 18, 2024
CompletedOctober 18, 2024
July 1, 2024
4.2 years
September 29, 2015
February 15, 2023
July 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-cause Mortality.
90 days following study randomization.
Secondary Outcomes (13)
RRT Dependence
90 days following study randomization.
Composite of Death or RRT Dependence.
90 days following study randomization.
Measurement of Estimated Glomerular Filtration Rate.
90 days following study randomization.
Measurement of Albuminuria.
90 days following study randomization.
Major Adverse Kidney Outcomes.
90 days following study randomization.
- +8 more secondary outcomes
Study Arms (2)
Standard RRT initiation
ACTIVE COMPARATORRRT initiation will be guided by the presence of one or more clinical indications. Even in the absence of one of these indications, RRT may be commenced at the discretion of the treating physician.
Accelerated RRT initiation
EXPERIMENTALA dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria.
Interventions
In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops: serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI \> 72 hours following the time of randomization.
A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Admission to an intensive care unit (ICU)
- Evidence of kidney dysfunction \[serum creatinine ≥100 µmol/L (women) and ≥ 130 µmol/L (men)\]
- Evidence of severe AKI defined by at least 1 of the following 3 criteria:
- i) ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization; OR ii) Achievement of a serum creatinine ≥ 354 µmol/L with evidence of a minimum increase of 27 µmol/L from pre-morbid baseline or during the current hospitalization; OR iii) Urine output \< 6.0 mL/kg over the preceding 12 hours
You may not qualify if:
- Serum potassium \> 5.5 mmol/L
- Serum bicarbonate \< 15 mmol/L
- Presence of a drug overdose that necessitates initiation of RRT
- Lack of commitment to ongoing life support (including RRT)
- Any RRT within the previous 2 months (either acute or chronic RRT)
- Kidney transplant within the past 365 days
- Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate \< 20 mL/min/1.73 m2
- Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, thrombotic microangiopathy or acute interstitial nephritis
- Clinician(s) caring for patient believe(s) that immediate RRT is mandated
- Clinician(s) caring for patient believe(s) that deferral of RRT initiation is mandated
- at their discretion, clinicians may administer a bolus of intravenous furosemide (ie, "furosemide stress test") and evaluate the subsequent urine output to help guide decision making regarding the likelihood of AKI progression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Unity Health Torontolead
- Canadian Institutes of Health Research (CIHR)collaborator
- National Health and Medical Research Council, Australiacollaborator
- Baxter Healthcare Corporationcollaborator
- The George Institutecollaborator
- National Institute for Health Research, United Kingdomcollaborator
- Medical Research Institute of New Zealandcollaborator
- Health Research Council, New Zealandcollaborator
Study Sites (105)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of Florida
Gainesville, Florida, 32611, United States
University of Kentucy
Lexington, Kentucky, 40506, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Ballarat Hospital
Ballarat, 3350, Australia
Flinder Medical Centre
Bedford Park, 5042, Australia
Bendigo Hospital
Bendigo, 3550, Australia
Eastern Hospital (Box Hill and Maroondah Hospital)
Box Hill, Australia
Concord Hospital
Concord, 2139, Australia
The Northern Hospital
Epping, 3076, Australia
Geelong Hospital
Geelong, 3220, Australia
Austin Hospital
Heidelberg, 3084, Australia
Nepean Hospital
Kingswood, NSW 2747, Australia
The Alfred Hospital
Melbourne, Australia
Nambour General Hospital
Nambour, QLD 4560, Australia
Western Health (Footscray Hospital & Sunshine Hospital)
St Albans, VIC 3021, Australia
St. Vincent's Hospital
Sydney, 2010, Australia
Royal North Shore Hospital
Sydney, 2065, Australia
Royal Prince Alfred Hospital
Sydney, Australia
Princess Alexandra Hospital
Woolloongabba, Australia
Medical University Graz
Graz, 8036, Austria
Medical University Innsbruck
Innsbruck, Austria
Vienna General Hospital
Vienna, 1090, Austria
Antwerp University Hospital
Edegem, 2650, Belgium
Ghent University Hospital
Ghent, Belgium
Hospital de Clínicas de Porto Alegre - Rio Grande do Sul
Rio Branco, Brazil
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
Foothills Hospital
Calgary, Alberta, Canada
Misericordia Community Hospital
Edmonton, Alberta, T5R 4H5, Canada
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, Canada
Royal Alexandra Hospital
Edmonton, Alberta, Canada
Red Deer Regional Hospital
Red Deer, Alberta, T4N 4E7, Canada
Sturgeon Community Hospital
St. Albert, Alberta, T8N 6C4, Canada
Surrey Memorial Hospital, Fraser Health
Surrey, British Columbia, V3V 1Z2, Canada
St. Paul's Hospital - Providence Health Care
Vancouver, British Columbia, Canada
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8, Canada
Victoria General Hospital
Victoria, British Columbia, V8Z 6R5, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B 3X9, Canada
Health Sciences North
Greater Sudbury, Ontario, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Juravinski Hospital
Hamilton, Ontario, Canada
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
London Health Sciences Centre, University Hospital
London, Ontario, Canada
London Health Sciences Centre, Victoria Hospital
London, Ontario, Canada
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, Canada
Trillium Health Partners - Mississauga Hospital
Mississauga, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, L1G 2B9, Canada
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, Canada
The Ottawa Hospital, General Campus
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
Centre hospitalier de l'université de Montréal (Notre Dame)
Montreal, Quebec, Canada
Centre hospitalier de l'université de Montréal (St. Luc)
Montreal, Quebec, Canada
CHUM - Hôtel Dieu Montreal
Montreal, Quebec, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval (IUCPQ)
Québec, Quebec, G1V 4G5, Canada
Centre Hospitalier Universitaire de Quebec (CHUQ)
Québec, Quebec, Canada
Centre Hôspitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada
Centre de sante et de services sociaux de Trois-Rivieres (CIUSSS MCQ)
Trois-Rivières, Quebec, Canada
Regina Qu'Appelle Health Region
Saskatoon, Saskatchewan, Canada
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
The First Hospital of Jilin University
Changchun, China
Xiangya Hospital Central South University
Changsha, China
Guizhou Provincial People's Hospital
Guiyang, China
Shandong Provincial Hospital
Jinan, China
Zhongda Hospital Southeast University
Nanjing, China
Renmin Hospital of Wuhan University
Wuhan, China
Zhongnan Hospital of Wuhan University
Wuhan, China
The First Affiliated Hospital of Xi'An Jiaotong University
Xi'an, China
The First Affiliated Hospital of Xiamen University
Xiamen, China
Henan Provincial People's Hospital
Zhengzhou, China
Helsinki University Central Hospital
Helsinki, 00290, Finland
Tampere University Hospital
Tampere, 33521, Finland
Turku University Hospital
Turku, 20521, Finland
Hopital Louis Mourier
Colombes, 92700, France
Klinikum Coburg
Coburg, 96450, Germany
University Hospital Münster
Münster, 48149, Germany
St. Vincent's University Hospital
Dublin, Ireland
San Raffaele Hospital
Milan, 20132, Italy
Auckland City Hospital
Grafton, Auckland, 1148, New Zealand
Auckland Hospital DCCM
Auckland, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Hawke's Bay Hospital
Hastings, New Zealand
Rotorua Hospital
Rotorua, New Zealand
Wellington Hospital
Wellington, 6021, New Zealand
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011, Switzerland
Stoke Mandeville Hospital
Aylesbury, HP21 8AL, United Kingdom
Wycombe General Hospital
High Wycombe, HP11 2TT, United Kingdom
Leeds Teaching Hospital
Leeds, United Kingdom
Lewisham Hospital
London, SE13 6LH, United Kingdom
King's College Hospital
London, SE5 9RS, United Kingdom
Guy's and St. Thomas Hospital
London, United Kingdom
Nottingham University Hospital
Nottingham, NG5 1PB, United Kingdom
Princess Royal University Hospital
Orpington, BR6 8ND, United Kingdom
Related Publications (8)
McCoy IE, Liu KD, Ghamarian E, Quenot JP, Zarbock A, Bihorac A, Khoo B, Gallagher MP, Du B, Joannidis M, Kashani K, Tolwani A, Bagshaw SM, Wald R; STandard versus Accelerated initiation of Renal Replacement Therapy in AKI (STARRT-AKI) Investigators. Dialysis Dependence in Standard versus Accelerated Initiation of KRT in AKI: A Post Hoc Analysis. Clin J Am Soc Nephrol. 2025 May 1;20(5):601-607. doi: 10.2215/CJN.0000000672. Epub 2025 Mar 11.
PMID: 40232884DERIVEDZampieri 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: 38461657DERIVEDVaara ST, Serpa Neto A, Bellomo R, Adhikari NKJ, Dreyfuss D, Gallagher M, Gaudry S, Hoste E, Joannidis M, Pettila V, Wang AY, Kashani K, Wald R, Bagshaw SM, Ostermann M; STandard vs. Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) Investigators. Regional Practice Variation and Outcomes in the Standard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) Trial: A Post Hoc Secondary Analysis. Crit Care Explor. 2024 Feb 19;6(2):e1053. doi: 10.1097/CCE.0000000000001053. eCollection 2024 Feb.
PMID: 38380940DERIVEDWald R, Kirkham B, daCosta BR, Ghamarian E, Adhikari NKJ, Beaubien-Souligny W, Bellomo R, Gallagher MP, Goldstein S, Hoste EAJ, Liu KD, Neyra JA, Ostermann M, Palevsky PM, Schneider A, Vaara ST, Bagshaw SM. Fluid balance and renal replacement therapy initiation strategy: a secondary analysis of the STARRT-AKI trial. Crit Care. 2022 Nov 24;26(1):360. doi: 10.1186/s13054-022-04229-0.
PMID: 36424662DERIVEDFayad 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: 36416787DERIVEDSTARRT-AKI Investigators; Canadian Critical Care Trials Group; Australian and New Zealand Intensive Care Society Clinical Trials Group; United Kingdom Critical Care Research Group; Canadian Nephrology Trials Network; Irish Critical Care Trials Group; Bagshaw SM, Wald R, Adhikari NKJ, Bellomo R, da Costa BR, Dreyfuss D, Du B, Gallagher MP, Gaudry S, Hoste EA, Lamontagne F, Joannidis M, Landoni G, Liu KD, McAuley DF, McGuinness SP, Neyra JA, Nichol AD, Ostermann M, Palevsky PM, Pettila V, Quenot JP, Qiu H, Rochwerg B, Schneider AG, Smith OM, Thome F, Thorpe KE, Vaara S, Weir M, Wang AY, Young P, Zarbock A. Timing of Initiation of Renal-Replacement Therapy in Acute Kidney Injury. N Engl J Med. 2020 Jul 16;383(3):240-251. doi: 10.1056/NEJMoa2000741.
PMID: 32668114DERIVEDSTARRT-AKI Investigators. Statistical analysis plan for the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI) trial. Crit Care Resusc. 2019 Sep;21(3):162-170.
PMID: 31462203DERIVEDSTARRT-AKI Investigators. STandard versus Accelerated initiation of Renal Replacement Therapy in Acute Kidney Injury: Study Protocol for a Multi-National, Multi-Center, Randomized Controlled Trial. Can J Kidney Health Dis. 2019 Jun 10;6:2054358119852937. doi: 10.1177/2054358119852937. eCollection 2019.
PMID: 31218013DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ron Wald
- Organization
- Unity Health Toronto
Study Officials
- PRINCIPAL INVESTIGATOR
Ron Wald, MDCM MPH
Unity Health Toronto
- PRINCIPAL INVESTIGATOR
Sean M Bagshaw, MD MSc
University of Alberta
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 6, 2015
Study Start
October 1, 2015
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
October 18, 2024
Results First Posted
October 18, 2024
Record last verified: 2024-07