Erythropoietin Role in Acute Kidney Injury (EAKI): a Pragmatic Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 134
- Locations
- 1
- Primary Endpoint
- Transfusion
Study Overview
Brief Summary
The use of erythropoietin to treat anemia in acute kidney injury (AKI) is controversial. No previous clinical trial has assessed the possible reduction of transfusions when erythropoietin is started very early in a setting of in-hospital acute kidney injury.
This randomised multicenter pragmatic clinical trial will compare the need for transfusion in acute kidney injury between two groups: group 1 will receive erythopoietin 4000 UI every other day and group 2 the usual treatment.
Detailed Description
Introduction
Background and rationale
Since the release of the recombinant human erythropoietin (rhuEPO) at the beginning of the 90s, transfusions are less needed to treat anemia in chronic kidney disease patients. This has been a major revolution in the management of renal anemia in chronic kidney disease and led to a tremendous decrease in hepatitis B and C transmissions in dialysis patients.
However the use of rHuEPO to treat anemia in acute kidney injury (AKI) is controversial. AKI is a common disease with a worldwide incidence estimated at 21% and a trend to be higher in the critical care setting.
The Kidney Disease Improving Global Outcomes (KDIGO) work group combined the RIFLE and AKIN classifications of AKI. Therefore, AKI has been defined as an increase in serum creatinine (SCr) ≥0.3 mg/dL (≥26.5 μmol/L) within 48 h or an increase in SCr to ≥1.5 times baseline within the last 7 days or a urine volume of <0.5 mL/kg/h for 6 hours.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All adult patients > 18 years old hospitalized with acute kidney injury and anemia
Exclusion Criteria
- •pregnant women, terminally ill patients, patients with major or minor thalassemia, patients with stable chronic kidney disease or patients on dialysis and patients who were receiving rHuEPO or any erythropoiesis-stimulating agent (ESA) before admission.
Arms & Interventions
Group 1
Recombinant human erythropoietin 4000 UI will be administered subcutaneously every other day
Intervention: Erythropoietin (Drug)
Outcomes
Primary Outcomes
Transfusion
Time Frame: Admission- One month
Number of red blood cell transfusions
Secondary Outcomes
- Renal survival(Admission - One month)
- Mortality(Admission - One month)
Investigators
Mabel Aoun
MD, instructor, nephrology department
Saint-Joseph University