A Study Comparing Standard Treatment versus Accelerated Initiation of Renal Replacement Therapy for Acute Kidney Injury
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-002877
NCT ID: NCT02568722
Sponsor Protocol Number: STARRT-AKI
About this study
The purpose of this study is to determine if, in critically ill patients with severe acute kidney injury, an earlier start of renal replacement therapy compared to standard treatment will lead to improved survival and recovery of kidney function.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 acute kidney injury defined by at least 1 of 3 criteria
- ≥ 2-fold increase in serum creatinine from a known pre-morbid baseline or during the current hospitalization
- 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
- Urine output < 6.0 mL/kg over the preceding 12 hours
Exclusion Criteria
- Serum potassium > 5.5 mmol/L
- Serum bicarbonate < 15 mmol/L
- Presence of a drug overdose that necessitates initiation of renal replacement therapy
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available