Acute Kidney InjuryNCT02568722
Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)
A study testing Standard RRT initiation and Accelerated RRT initiation in people with Acute Kidney Injury, run by Unity Health Toronto at 105 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Standard RRT initiation and Accelerated RRT initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,019 participants
- Where
- 105 sitesin 15 countries
- Study dates
- Oct 2015to Dec 2019
- Phase
- Interventional
- 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
- 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:
- ≥ 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
105 sites in 15 countries.
105 sites in 15 countries
Canada42 sites
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Foothills Hospital
Calgary, Alberta
Misericordia Community Hospital
Edmonton, Alberta, T5R 4H5
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Grey Nuns Community Hospital
Edmonton, Alberta
Royal Alexandra Hospital
Edmonton, Alberta
Health Sciences North
Greater Sudbury, Ontario
Hamilton General Hospital
Hamilton, Ontario
Juravinski Hospital
Hamilton, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Kingston General Hospital
Kingston, Ontario
London Health Sciences Centre, University Hospital
London, Ontario
London Health Sciences Centre, Victoria Hospital
London, Ontario
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario
Trillium Health Partners - Mississauga Hospital
Mississauga, Ontario
Centre hospitalier de l'université de Montréal (Notre Dame)
Montreal, Quebec
Centre hospitalier de l'université de Montréal (St. Luc)
Montreal, Quebec
CHUM - Hôtel Dieu Montreal
Montreal, Quebec
Hopital Maisonneuve-Rosemont
Montreal, Quebec
McGill University Health Centre (MUHC)
Montreal, Quebec
Lakeridge Health
Oshawa, Ontario, L1G 2B9
The Ottawa Hospital, Civic Campus
Ottawa, Ontario
The Ottawa Hospital, General Campus
Ottawa, Ontario
Institut Universitaire de Cardiologie et de Pneumologie de Québec- Université Laval (IUCPQ)
Québec, Quebec, G1V 4G5
Centre Hospitalier Universitaire de Quebec (CHUQ)
Québec, Quebec
Red Deer Regional Hospital
Red Deer, Alberta, T4N 4E7
Regina Qu'Appelle Health Region
Saskatoon, Saskatchewan
Centre Hôspitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec
Sturgeon Community Hospital
St. Albert, Alberta, T8N 6C4
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1B 3X9
Surrey Memorial Hospital, Fraser Health
Surrey, British Columbia, V3V 1Z2
Mount Sinai Hospital
Toronto, Ontario
St. Michael's Hospital
Toronto, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
Toronto Western Hospital
Toronto, Ontario
Centre de sante et de services sociaux de Trois-Rivieres (CIUSSS MCQ)
Trois-Rivières, Quebec
St. Paul's Hospital - Providence Health Care
Vancouver, British Columbia
Royal Jubilee Hospital
Victoria, British Columbia, V8R 1J8
Victoria General Hospital
Victoria, British Columbia, V8Z 6R5
Health Sciences Centre
Winnipeg, Manitoba
Australia16 sites
Ballarat Hospital
Ballarat, 3350
Flinder Medical Centre
Bedford Park, 5042
Bendigo Hospital
Bendigo, 3550
Eastern Hospital (Box Hill and Maroondah Hospital)
Box Hill
Concord Hospital
Concord, 2139
The Northern Hospital
Epping, 3076
Geelong Hospital
Geelong, 3220
Austin Hospital
Heidelberg, 3084
Nepean Hospital
Kingswood, NSW 2747
The Alfred Hospital
Melbourne
Nambour General Hospital
Nambour, QLD 4560
Western Health (Footscray Hospital & Sunshine Hospital)
St Albans, VIC 3021
St. Vincent's Hospital
Sydney, 2010
Royal North Shore Hospital
Sydney, 2065
Royal Prince Alfred Hospital
Sydney
Princess Alexandra Hospital
Woolloongabba
China12 sites
Beijing Friendship Hospital, Capital Medical University
Beijing
Peking Union Medical College Hospital
Beijing
The First Hospital of Jilin University
Changchun
Xiangya Hospital Central South University
Changsha
Guizhou Provincial People's Hospital
Guiyang
Shandong Provincial Hospital
Jinan
Zhongda Hospital Southeast University
Nanjing
Renmin Hospital of Wuhan University
Wuhan
Zhongnan Hospital of Wuhan University
Wuhan
The First Affiliated Hospital of Xi'An Jiaotong University
Xi'an
The First Affiliated Hospital of Xiamen University
Xiamen
Henan Provincial People's Hospital
Zhengzhou
United Kingdom8 sites
Stoke Mandeville Hospital
Aylesbury, HP21 8AL
Wycombe General Hospital
High Wycombe, HP11 2TT
Leeds Teaching Hospital
Leeds
Lewisham Hospital
London, SE13 6LH
King's College Hospital
London, SE5 9RS
Guy's and St. Thomas Hospital
London
Nottingham University Hospital
Nottingham, NG5 1PB
Princess Royal University Hospital
Orpington, BR6 8ND
United States6 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Florida
Gainesville, Florida, 32611
University of Kentucy
Lexington, Kentucky, 40506
Rhode Island Hospital
Providence, Rhode Island, 02903
The Miriam Hospital
Providence, Rhode Island, 02906
Mayo Clinic
Rochester, Minnesota, 55905
New Zealand6 sites
Auckland Hospital DCCM
Auckland
Christchurch Hospital
Christchurch, 8011
Auckland City Hospital
Grafton, Auckland, 1148
Hawke's Bay Hospital
Hastings
Rotorua Hospital
Rotorua
Wellington Hospital
Wellington, 6021
Austria3 sites
Medical University Graz
Graz, 8036
Medical University Innsbruck
Innsbruck
Vienna General Hospital
Vienna, 1090
Finland3 sites
Helsinki University Central Hospital
Helsinki, 00290
Tampere University Hospital
Tampere, 33521
Turku University Hospital
Turku, 20521
Belgium2 sites
Antwerp University Hospital
Edegem, 2650
Ghent University Hospital
Ghent
Germany2 sites
Klinikum Coburg
Coburg, 96450
University Hospital Münster
Münster, 48149
Brazil1 site
Hospital de Clínicas de Porto Alegre - Rio Grande do Sul
Rio Branco
Switzerland1 site
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1011
About this study
Official title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)
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:
- Improved survival (primary outcome); and
- Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days
Read the detailed description
Acute kidney injury (AKI) is a common and devastating complication of critical illness. Once AKI is established, treatment is largely supportive and no intervention has been found to restore kidney function or improve overall survival. Renal replacement therapy (RRT), usually in the form of hemodialysis, is frequently needed to manage patients with severe AKI. Such patients have an in-hospital mortality that consistently exceeds 50% with delays in RRT initiation implicated as a possible contributor. A recent meta-analysis suggested that earlier initiation of RRT may improve survival, but this is based on data derived overwhelmingly from observational studies. The investigators recently completed a multi-centre randomized controlled pilot trial that confirmed the feasibility of allocating patients to two different strategies of RRT initiation. Patient recruitment and follow-up, as well as patient safety, were successfully demonstrated during the pilot phase of this research program. The optimal timing of RRT initiation is an existing knowledge gap and a clear priority for investigation.
- Conditions
- Acute Kidney Injury
- Being tested
- Standard RRT initiation, Accelerated RRT initiation
- Keywords
- Renal replacement therapy, Acute kidney injury, Dialysis, Hemodialysis, Critical illness
- 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.
Standard RRT initiationOther
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.
Accelerated RRT initiationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard RRT initiation | Active comparator | RRT 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. Receives: Other: Standard RRT initiation |
| Accelerated RRT initiation | Experimental | A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria. Receives: Other: Accelerated RRT initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause Mortality.
Measured: 90 days following study randomization.
Secondary outcomes (13)
RRT Dependence
Measured: 90 days following study randomization.
Composite of Death or RRT Dependence.
Measured: 90 days following study randomization.
Measurement of Estimated Glomerular Filtration Rate.
Measured: 90 days following study randomization.
Measurement of Albuminuria.
Measured: 90 days following study randomization.
Major Adverse Kidney Outcomes.
Defined as death, RRT dependence or sustained reduction in kidney function (defined as eGFR < 75% baseline eGFR).
Measured: 90 days following study randomization.
Mechanical Ventilation-free Days.
Measured: Measured from randomization through day 28.
Vasoactive Therapy-free Days
Measured: Measured from randomization through day 28.
ICU-free Days
Measured: Measured from randomization through day 28.
Hospitalization-free Days
Measured: Measured from randomization through day 90.
Death in ICU
Measured: Measured in-hospital and at day 28.
EuroQoL EQ-5D-5L.
A measure of health-related quality of life and patient utility.
Measured: Measured at day 90 and at day 365.
Health Care Costs.
Measured: Measured from baseline through day 365.
Composite of Death or RRT Dependence.
Measured: Measured at day 365.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2019
- Study completionDec 2019
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 (8)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,019 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia, Baxter Healthcare Corporation, The George Institute, National Institute for Health Research, United Kingdom, Medical Research Institute of New Zealand, Health Research Council, New Zealand
- Responsible party
- Sponsor
- Investigators
- Ron Wald, MDCM MPH, Principal investigator, Unity Health TorontoSean M Bagshaw, MD MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568722
- Sponsor's protocol ID
- STARRT-AKI: Principal Trial
- Status last verified
- Jul 2024
- First submitted
- 29 Sep 2015
- Last updated
- 18 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 40232884Zampieri 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 38461657Vaara 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.
PubMed 38380940Wald 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.
PubMed 36424662Fayad 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 36416787STARRT-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.
PubMed 32668114STARRT-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.
PubMed 31462203STARRT-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.
PubMed 31218013
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI): A Multi-Centre, Randomized, Controlled Trial (Principal Trial)
- ClinicalTrials.gov ID
- NCT02568722
- Acronym / sponsor ID
- STARRT-AKI: Principal Trial
- Conditions
- Acute Kidney Injury
- Keywords
- Renal replacement therapy, Acute kidney injury, Dialysis, Hemodialysis, Critical illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,019 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia, Baxter Healthcare Corporation, The George Institute, National Institute for Health Research, United Kingdom, Medical Research Institute of New Zealand, Health Research Council, New Zealand
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Posted 18 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Improved survival (primary outcome); and
- Recovery of kidney function (principal secondary outcome), defined as independence from RRT at 90 days
Detailed description
Acute kidney injury (AKI) is a common and devastating complication of critical illness. Once AKI is established, treatment is largely supportive and no intervention has been found to restore kidney function or improve overall survival. Renal replacement therapy (RRT), usually in the form of hemodialysis, is frequently needed to manage patients with severe AKI. Such patients have an in-hospital mortality that consistently exceeds 50% with delays in RRT initiation implicated as a possible contributor. A recent meta-analysis suggested that earlier initiation of RRT may improve survival, but this is based on data derived overwhelmingly from observational studies. The investigators recently completed a multi-centre randomized controlled pilot trial that confirmed the feasibility of allocating patients to two different strategies of RRT initiation. Patient recruitment and follow-up, as well as patient safety, were successfully demonstrated during the pilot phase of this research program. The optimal timing of RRT initiation is an existing knowledge gap and a clear priority for investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard RRT initiation | Active comparator | Other: Standard RRT initiationRRT 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 | Experimental | Other: Accelerated RRT initiationA dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of the patient meeting the eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (11 listed)
- 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)
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 |
|---|---|---|
| Standard RRT initiationIn 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. | Other | Standard RRT initiation |
| Accelerated RRT initiationA 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. | Other | Accelerated RRT initiation |
Primary outcome
All-cause Mortality.
Time frame: 90 days following study randomization.
13 secondary outcomes
RRT Dependence
Time frame: 90 days following study randomization.
Composite of Death or RRT Dependence.
Time frame: 90 days following study randomization.
Measurement of Estimated Glomerular Filtration Rate.
Time frame: 90 days following study randomization.
Measurement of Albuminuria.
Time frame: 90 days following study randomization.
Major Adverse Kidney Outcomes.
Time frame: 90 days following study randomization.
Mechanical Ventilation-free Days.
Time frame: Measured from randomization through day 28.
Vasoactive Therapy-free Days
Time frame: Measured from randomization through day 28.
ICU-free Days
Time frame: Measured from randomization through day 28.
Hospitalization-free Days
Time frame: Measured from randomization through day 90.
Death in ICU
Time frame: Measured in-hospital and at day 28.
EuroQoL EQ-5D-5L.
Time frame: Measured at day 90 and at day 365.
Health Care Costs.
Time frame: Measured from baseline through day 365.
Composite of Death or RRT Dependence.
Time frame: Measured at day 365.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40232884McCoy 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.
- 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 38380940Vaara 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.
- Derived from this study: PubMed 36424662Wald 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.
- 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 32668114STARRT-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.
- Derived from this study: PubMed 31462203STARRT-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.
- Derived from this study: PubMed 31218013STARRT-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.
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Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Ron Wald, MDCM MPH principal investigator
Unity Health Toronto
Sean M Bagshaw, MD MSc principal investigator
University of Alberta
105 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard RRT initiation and Accelerated RRT initiation in people with Acute Kidney Injury, run by Unity Health Toronto at 105 sites in 15 countries.
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 5 inclusion and 11 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 105 sites in Canada, Australia, China, United Kingdom, United States and 10 more countries. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2024). 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?
All-cause Mortality. (time frame: 90 days following study randomization.). 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 NCT02568722, which also lists 8 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 18 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.