Abstract: INFO21
Erythropoietin in Acute Kidney Injury (EAKI): a Pragmatic Clinical Trial
Session Information
- Informational Posters
October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category:
- No subcategory defined
Authors
- Aoun, Mabel Habib, Saint-Georges Hospital Ajaltoun, Beirut, Lebanon
- Finianos, Serge S., Hotel-Dieu de France Hospital, Beyrouth, Lebanon
- Azar, Hiba, Saint-Joseph University, Beirut, Lebanon
- El boueri, Celine, Saint-Georges Hospital Ajaltoun , Beirut, Lebanon
- Beaini, Chadia H., Bellevue Medical Center, Mansourieh, Lebanon
- Maroun, Therese Y., Hospital St. Joseph, Beirut, Lebanon
- Sleilaty, Ghassan, Saint-Joseph University, Beirut, Lebanon
- Chelala, Dania, Saint-Joseph University, Beirut, Lebanon
Description
The role of rHuEPO for anemia in acute kidney injury (AKI) is not well studied.
The primary objective of this trial is to compare the number of red blood cell transfusions in patients with AKI and anemia whether receiving or not rHuEPO. The secondary objectives are a) to compare the renal survival between the 2 groups, b) to compare the patient survival between the 2 groups.
This is a randomized, controlled, multicenter, pragmatic clinical trial. Patients will be randomized to 1 of 2 arms: group 1 will receive rHuEPO and group 2 the usual treatment.
All patients > 18 years old hospitalized with AKI (creatinine rise of >0.3 mg/dl from baseline) and anemia (Hemoglobin<11 g/dl) will be included.
Exclusion criteria: pregnant women, terminally ill patients, active bleeding, chronic dialysis and those receiving erythropoiesis-stimulating agent before admission.
Patients will be randomly assigned to: Group 1 will receive rHuEPO at least 150 UI/Kg/week subcutaneously divided into 3 doses per week until Hb reaches 12 g/dl. Group 2 will receive the usual treatment.
Primary endpoint: Number of red blood cell transfusions during the hospitalisation.
Secondary endpoints: Renal recovery. All-cause mortality.
Every patient will be followed from first day of acute kidney injury till discharge or transfer or death.
The total sample size needed would be 198 patients, 99 patients in each arm.
Data collection: Demographics, medical history and admission blood test mainly serum creatinine, hemoglobin, MCV, ferritin, TSAT, LDH, vitamin B12, folic acid, CRP, reticulocyte count.
Statistical analysis will be performed. A P-value of ≤0.05 is considered statistically significant.
Follow-up: Hemoglobin and creatinine will be measured. Medications administered during the hospitalization will be collected. Transfusions will be noted. Clinical follow-up: blood pressure, average hospital length of stay (LOS), oligo-anuria at any stage of the AKI, need for dialysis and number of days till serum creatinine starts to decrease will be collected. Adverse events will be also reported such as any thrombotic event.
The study got the approval from ethics committee of Saint-Joseph University HDF1115 and is in agreement with the Helsinki Declaration of 1975. This trial is registered on ClinicalTrials.gov.NCT03401710.