Recombinant human erythropoietin therapy in critically ill patients: a dose-response study [ISRCTN48523317].
BACKGROUND
The aim of this study was to assess the efficacy of two dosing schedules of recombinant human erythropoietin (rHuEPO) in increasing haematocrit (Hct) and haemoglobin (Hb) and reducing exposure to allogeneic red blood cell (RBC) transfusion in critically ill patients.


METHODS
This was a prospective, randomized, multicentre trial. A total of 13 intensive care units participated, and a total of 148 patients who met eligibility criteria were enrolled. Patients were randomly assigned to receive intravenous iron saccharate alone (control group), intravenous iron saccharate and subcutaneous rHuEPO 40,000 units once per week (group A), or intravenous iron saccharate and subcutaneous rHuEPO 40,000 units three times per week (group B). rHuEPO was given for a minimum of 2 weeks or until discharge from the intensive care unit or death. The maximum duration of therapy was 3 weeks.


RESULTS
The cumulative number of RBC units transfused, the average numbers of RBC units transfused per patient and per transfused patient, the average volume of RBCs transfused per day, and the percentage of transfused patients were significantly higher in the control group than in groups A and B. No significant difference was observed between group A and B. The mean increases in Hct and Hb from baseline to final measurement were significantly greater in group B than in the control group. The mean increase in Hct was significantly greater in group B than in group A. The mean increase in Hct in group A was significantly greater than that in control individuals, whereas the mean increase in Hb did not differ significantly between the control group and group A.


CONCLUSIONS
Administration of rHuEPO to critically ill patients significantly reduced the need for RBC transfusion. The magnitude of the reduction did not differ between the two dosing schedules, although there was a dose response for Hct and Hb to rHuEPO in these patients.
Georgopoulos
Dimitris
D
Department of Intensive Care Medicine, University Hospital of Heraklion, University of Crete, Heraklion, Crete, Greece. georgop@med.uoc.gr
Matamis
Dimitris
D
Routsi
Christina
C
Michalopoulos
Argiris
A
Maggina
Nina
N
Dimopoulos
George
G
Zakynthinos
Epaminondas
E
Nakos
George
G
Thomopoulos
George
G
Mandragos
Kostas
K
Maniatis
Alice
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001803:Blood Transfusion / Q000706:statistics & numerical data*; D004305:Dose-Response Relationship, Drug; D004812:Epidemiologic Methods; D004912:Erythrocytes / Q000187:drug effects*; D004921:Erythropoietin / Q000008:administration & dosage*; D005260:Female; D006454:Hemoglobins / Q000187:drug effects*; D006801:Humans; D007501:Iron / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D013997:Time Factors
D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin; D007501:Iron