Randomised Pilot Study of Epoetin Beta - in critically ill patients

• Research type

  Research Study

• Full title

  A randomised pilot study to assess the effects of Epoetin beta on blood transfusion requirement and renal function in patients with critical illness/sepsis

• IRAS ID

  11932

• Contact name

  A Mikhail

• Sponsor organisation

  Abertawe Bro Morgannwg University NHS Trust

• Eudract number

  2008-003733-24

• ISRCTN Number

  0000000000000

• Clinicaltrials.gov Identifier

  0000000000000

• Research summary

  EPO has been used for several years to treat anaemia associated with renal failure. It has also been shown to be effective in treating anaemia in a number of other conditions (rheumatological disorders, trauma and surgery).An early pilot study in 2007/8 included two groups; one group (20 patients) undergoing CABG (received EPO as a single dose of 15,000 Units x 10 patients and 30,0000 units x 10 between 3-6 hours pre surgery). The other group were patients with critical illness and AKI (in ICU) who received EPO 2000 units x 3 daily for 7 days. This study also sought to assess safety and tolerability of EPO at the doses used.Cardiac patients were recruited according to the ??Cleveland Scoring system,CSS? for risk assessment of patients having open heart surgery. All patients entered into the study scored 7 or more (maximum score 12). Of the 20 patients recruited, 2 patients developed AKI requiring dialysis (due to pericardial effusion), they recovered renal function within 3 days.All patients showed a good response in respect of reticulocyte response and increased urine output.Of the 10 patients with critical illness and AKI due to sepsis/inflammatory response, 8 patients recovered renal function and became dialysis independent (5 of these patients recovered renal function within 5 days post initiation of EPO therapy, 3 patients recovered within 8 days. All patients showed good response in terms of haematopoietic response in terms of reticulocytosis and had increased urine output and recovery of renal function between day 5 ?? 10.Two of these 10 patients died of their presenting illness (sepsis and multi organ failure. In this group the results suggested a trend that renal function was improved within 24 hours of receiving EPO 2000 units three times a day. Patients in both arms tolerated the drug well.

• REC name

  Wales REC 3

• REC reference

  09/MRE09/5

• Date of REC Opinion

  29 May 2009

• REC opinion

  Further Information Favourable Opinion