Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Alere San Diego | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Accelerated RRT initiation | Experimental | A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated RRT initiation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of enrollment | >50% of eligible patients are successfully enrolled in the trial | 14 days |
| Feasibility of 90-day follow-up | Vital status and need for RRT at 90 days are successfully captured in >95% of participants |
Not provided
Inclusion Criteria (all of these need to be present):
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
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):
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ron Wald, MDCM MPH | Unity Health Toronto | Principal Investigator |
| Sean M Bagshaw, MD MSc | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada | ||
| St. Joseph's Healthcare |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39625781 | Derived | 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. | |
| 36416787 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard RRT initiation | Other | 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: 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:
|
|
| 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. | 14 days |
| Hamilton |
| Ontario |
| L8N 4A6 |
| Canada |
| London Health Sciences Centre - Victoria Hospital | London | Ontario | N6A 4G5 | Canada |
| London Health Sciences Centre - University Hospital | London | Ontario | N6C 6B5 | Canada |
| The Ottawa Hospital, General Campus | Ottawa | Ontario | K1H8L6 | Canada |
| The Ottawa Hospital, Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G1X5 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Centre hopitalier universitaire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Fayad AI, Buamscha DG, Ciapponi A. Timing of kidney replacement therapy initiation for acute kidney injury. Cochrane Database Syst Rev. 2022 Nov 23;11(11):CD010612. doi: 10.1002/14651858.CD010612.pub3. |
| 24093950 | Derived | Smith 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. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |