N/A
N=3,019
Standard vs. Accelerated Initiation of RRT in Acute Kidney Injury (STARRT-AKI: Principal Trial)
Acute Kidney Injury
Bottom Line
View on ClinicalTrials.gov: NCT02568722 ↗Enrolled (actual)
3,019
Serious AEs
0.8%
Results posted
Oct 2024
Primary outcome: Primary: All-cause Mortality. — 639; 643 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Standard RRT initiation (Other); Accelerated RRT initiation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Unity Health Toronto
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality. |
639; 643 | — |
| SECONDARY RRT Dependence |
— | — |
| SECONDARY Composite of Death or RRT Dependence. |
— | — |
| SECONDARY Measurement of Estimated Glomerular Filtration Rate. |
— | — |
| SECONDARY Measurement of Albuminuria. |
— | — |
| SECONDARY Major Adverse Kidney Outcomes. |
— | — |
| SECONDARY Mechanical Ventilation-free Days. |
— | — |
| SECONDARY Vasoactive Therapy-free Days |
— | — |
| SECONDARY ICU-free Days |
— | — |
| SECONDARY Hospitalization-free Days |
— | — |
| SECONDARY Death in ICU |
— | — |
| SECONDARY EuroQoL EQ-5D-5L. |
— | — |
| SECONDARY Health Care Costs. |
— | — |
| SECONDARY Composite of Death or RRT Dependence. |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT02568722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.