Acute Kidney InjuryPhase 2STARRT-AKINCT01557361
Standard Versus Accelerated Initiation of Dialysis in Acute Kidney Injury
A Phase 2 study testing Accelerated RRT initiation and Standard RRT initiation in people with Acute Kidney Injury, run by Unity Health Toronto at 11 sites in Canada.
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 with standard initiation, is: 1. 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?
- Accelerated RRT initiation and Standard RRT initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesCanada
- Study dates
- May 2012to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Evidence of kidney dysfunction (serum creatinine ≥ 100 µmol/L (women) or
- ≥ 130 µmol/L (men))
- Evidence of severe AKI defined by at least 2 of the following 3 criteria:
- i-A 2-fold increase in serum creatinine during hospitalization or from a known pre-hospitalization baseline ii-Oliguria as defined by total urine output < 6 mL/kg over the preceding 12 hours iii-Whole blood Neutrophil Gelatinase-Associated Lipocalin (NGAL) ≥ 400ng/mL
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- Likelihood that an absolute indication for RRT will not arise in the subsequent 24 hours based on the most recent bloodwork for the following parameters: i- Serum potassium ≤ 5.5 mmol/L and ii- Serum bicarbonate ≥ 15 mmol/L
- Central venous pressure ≥ 8 mmHg
- Exclusion Criteria (the presence of one of these would disqualify eligibility):
- Lack of commitment to ongoing life support
- Presence of a drug overdose that necessitates initiation of RRT
- Any RRT within the previous 2 months
- Presence or clinical suspicion of renal obstruction, rapidly progressive glomerulonephritis, vasculitis, or acute interstitial nephritis
- Advanced chronic kidney disease, defined by an estimated glomerular filtration rate < 30 mL/min/1.73 m2, based on pre-hospitalization blood work
- Kidney transplant within the past 365 days
- At the time of screening, doubling of serum creatinine has been present for > 48 hours
- Clinician(s) caring for patient believe(s) that immediate dialysis is absolutely mandated
- Clinician(s) caring for patient believe(s) that deferral of dialysis initiation is mandated
- Patient or substitute decision maker can not provide consent within 12 hours of study eligibility
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 4G5
London Health Sciences Centre - University Hospital
London, Ontario, N6C 6B5
The Ottawa Hospital, General Campus
Ottawa, Ontario, K1H8L6
The Ottawa Hospital, Civic Campus
Ottawa, Ontario, K1Y 4E9
Centre hopitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
University Health Network
Toronto, Ontario, M5G 2N2
Mount Sinai Hospital
Toronto, Ontario, M5G1X5
Sunnybrook Health Sciences Centre
Toronto, Ontario
About this study
Official title: STandard Versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury (STARRT-AKI)
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 with standard initiation, is:
- Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
- Safe, from the perspective of potential adverse events associated with earlier initiation of RRT
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%. Delay in the initiation of RRT has been implicated as a possible contributor to this poor outcome. A recent meta-analysis suggested that earlier initiation of RRT may improve survival. However, completed trials to date have been small, single centre, limited by study quality, and have shown considerable heterogeneity in terms of definitions used for "early" RRT initiation.
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 with standard initiation, is:
- Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
- Safe, from the perspective of potential adverse events associated with the earlier or later initiation of RRT
This pilot trial is intended to guide and inform the design of a phase III multicentre randomized trial of accelerated versus standard initiation of RRT in critically ill patients that will evaluate the impact of the intervention on 90-day all-cause mortality and recovery of kidney function.
- Conditions
- Acute Kidney Injury
- Being tested
- Accelerated RRT initiation, Standard RRT initiation
- Keywords
- renal replacement therapy, dialysis, acute kidney injury, 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.
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.
Standard RRT initiationOther
Patients will be carefully followed over a period of 7 days to identify potential indications for RRT. The trial team will ask that the clinical team consider RRT initiation if there are:
- Criteria for persistent AKI (serum creatinine has not declined by more than 50% from value recorded at time of eligibility) AND
II. At least one of the following indications for RRT initiation:
- Serum potassium ≥6.0 mmol/L, or
- Serum bicarbonate ≤ 10 mmol/L, or
- Evidence of severe respiratory failure, based on a PaO2/FiO2 <200 and bilateral infiltrates on the chest x-ray, or
- By 72 hours after randomization, creatinine has not declined by more than 50% from that recorded at the time of randomization
| Study group | Role | What they receive |
|---|---|---|
| Standard RRT initiation | Active comparator | RRT is initiated >12 hours after eligibility determination. Once a decision is made to start RRT, a dialysis catheter will be placed and RRT initiated as soon as possible. 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 eligibility. Receives: Other: Accelerated RRT initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of protocol adherence
>90% of participants in the accelerated initiation arm start RRT within 12 hours of eligibility AND >90% of participants randomized to the standard initiation arm who ultimately receive RRT, start RRT at least 12 hours following eligibility determination
Measured: 14 days
Secondary outcomes (3)
Feasibility of enrollment
>50% of eligible patients are successfully enrolled in the trial
Measured: 14 days
Feasibility of 90-day follow-up
Vital status and need for RRT at 90 days are successfully captured in >95% of participants
Measured: 90 days
Safety outcomes
Serious adverse effects, with a particular focus on those that are potentially attributable to the study treatment, vascular accesss complications (including hemorrhage, thrombosis and infection) and complications associated with the delivery of RRT (dialysis-associated hypotension, electrolyte abnormalities) will be examined.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alere San Diego
- 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
- NCT01557361
- Sponsor's protocol ID
- CIHR MOP 111116
- Acronym
- STARRT-AKI
- Status last verified
- Aug 2013
- First submitted
- 13 Mar 2012
- Last updated
- 12 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wing S, Neto AS, Bellomo R, Clark EG, Gallagher M, Liangos O, Prasad B, Silver SA, Tolwani A, Bagshaw S, Wald R. CKD Progression after Acute Kidney Injury: A Secondary Analysis of the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury Trial. Kidney360. 2025 Apr 1;6(4):636-644. doi: 10.34067/KID.0000000663. Epub 2024 Dec 3.
PubMed 39625781Fayad 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 36416787Smith OM, Wald R, Adhikari NK, Pope K, Weir MA, Bagshaw SM; Canadian Critical Care Trials Group. Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial. Trials. 2013 Oct 5;14:320. doi: 10.1186/1745-6215-14-320.
PubMed 24093950
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2014. 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)
- ClinicalTrials.gov ID
- NCT01557361
- Acronym / sponsor ID
- STARRT-AKI / CIHR MOP 111116
- Conditions
- Acute Kidney Injury
- Keywords
- renal replacement therapy, dialysis, acute kidney injury, hemodialysis, critical illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Alere San Diego
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Not posted in the source record
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 with standard initiation, is:
- Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
- Safe, from the perspective of potential adverse events associated with earlier initiation of RRT
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%. Delay in the initiation of RRT has been implicated as a possible contributor to this poor outcome. A recent meta-analysis suggested that earlier initiation of RRT may improve survival. However, completed trials to date have been small, single centre, limited by study quality, and have shown considerable heterogeneity in terms of definitions used for "early" RRT initiation.
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 with standard initiation, is:
- Feasible, in terms of adherence to the protocol (primary outcome), recruitment rates, and achievement of follow-up; and
- Safe, from the perspective of potential adverse events associated with the earlier or later initiation of RRT
This pilot trial is intended to guide and inform the design of a phase III multicentre randomized trial of accelerated versus standard initiation of RRT in critically ill patients that will evaluate the impact of the intervention on 90-day all-cause mortality and recovery of kidney function.
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 is initiated >12 hours after eligibility determination. Once a decision is made to start RRT, a dialysis catheter will be placed and RRT initiated as soon as possible. |
| 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 eligibility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age ≥ 18 years
- Admission to an intensive care unit
- Evidence of kidney dysfunction (serum creatinine ≥ 100 µmol/L (women) or
- ≥ 130 µmol/L (men))
- Evidence of severe AKI defined by at least 2 of the following 3 criteria:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 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 |
| Standard RRT initiationPatients will be carefully followed over a period of 7 days to identify potential indications for RRT. The trial team will ask that the clinical team consider RRT initiation if there are: I. Criteria for persistent AKI (serum creatinine has not declined by more than 50% from value recorded at time of eligibility) AND II. At least one of the following indications for RRT initiation: 1. Serum potassium ≥6.0 mmol/L, or 2. Serum bicarbonate ≤ 10 mmol/L, or 3. Evidence of severe respiratory failure, based on a PaO2/FiO2 <200 and bilateral infiltrates on the chest x-ray, or 4. By 72 hours after randomization, creatinine has not declined by more than 50% from that recorded at the time of randomization | Other | Standard RRT initiation |
Primary outcome
Feasibility of protocol adherence
Time frame: 14 days
>90% of participants in the accelerated initiation arm start RRT within 12 hours of eligibility AND >90% of participants randomized to the standard initiation arm who ultimately receive RRT, start RRT at least 12 hours following eligibility determination
3 secondary outcomes
Feasibility of enrollment
Time frame: 14 days
Feasibility of 90-day follow-up
Time frame: 90 days
Safety outcomes
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2014.
- Derived from this study: PubMed 39625781Wing S, Neto AS, Bellomo R, Clark EG, Gallagher M, Liangos O, Prasad B, Silver SA, Tolwani A, Bagshaw S, Wald R. CKD Progression after Acute Kidney Injury: A Secondary Analysis of the Standard versus Accelerated Initiation of Renal Replacement Therapy in Acute Kidney Injury Trial. Kidney360. 2025 Apr 1;6(4):636-644. doi: 10.34067/KID.0000000663. Epub 2024 Dec 3.
- 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 24093950Smith OM, Wald R, Adhikari NK, Pope K, Weir MA, Bagshaw SM; Canadian Critical Care Trials Group. Standard versus accelerated initiation of renal replacement therapy in acute kidney injury (STARRT-AKI): study protocol for a randomized controlled trial. Trials. 2013 Oct 5;14:320. doi: 10.1186/1745-6215-14-320.
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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.
Ron Wald, MDCM MPH principal investigator
Unity Health Toronto
Sean M Bagshaw, MD MSc principal investigator
University of Alberta
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Accelerated RRT initiation and Standard RRT initiation in people with Acute Kidney Injury, run by Unity Health Toronto at 11 sites in Canada.
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 19 inclusion and 0 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 12 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of protocol adherence (time frame: 14 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 NCT01557361, which also lists 3 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 12 Sep 2014.