A randomised study to assess the effects of Epoetin Beta on renal function in patients with critical illness(with or without multi-organ failure)

Phase 1

• Conditions: Sepsis/Acute renal failure; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2008-003733-24-GB
• Lead Sponsor: Abertawe Bro Morgannwg University NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-03
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Aged >18 years
ITU stay > 12 hours – expected to stay for at least 3 days
Hb less than 11.5 gm/dl
Acute renal failure /and or requiring any form of inotrope support
Defined as;
Urine output <0.5ml /kg/hr for more than 1 hour despite adequate fluid replacement
Need for renal replacement therapy for persistent acidosis/ fluid overload/hyperkalaemia
Andraised creatinine >160mmol/L or doubling of baseline serum creatinine

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

Patients with haematological malignancies
Haemolytic anaemia
Haemorrhage (post operative/GI bleeding/multiple trauma)
Hypertensive emergencies
Known active solid tumour malignancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: This will be achieved by the cessation of the need for haemodialysis, increased urine output and improvement in serum creatinine levels;Main Objective: To assess the efficacy of Epo to decrease blood transfusion requirements in patients with critical illness;Secondary Objective: To assess the possible effect(s) of Epo on renal function in critically ill patients with and without multi-organ failure.;<br> Primary end point(s): 1. Demonstrate shorter time to achieve normal renal function compared with placebo.<br> <br> 2. An attenuated renal injury as assessed by urinary markers to critical illness compared with placebo.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess the efficacy of Epo to decrease blood transfusion requirements in patients with critical illness.;Timepoint(s) of evaluation of this end point: This will be achieved by monitoring haemoglobin levels and routine consultant evaluation in respect to cardiovascular status.