None listed
Conditions
Brief summary
The primary objective of this trial is to determine the feasibility of a pivotal clinical trial of intravenous iron and erythropoietin in adult survivors of critical illness requiring treatment in the intensive care unit. The hypothesis of the pilot phase of the trial is that a clinical trial of intravenous iron and erythropoietin is feasible based on the capacity of the study investigators to enrol sufficient eligible participants and deliver the study medications and follow up the patients appropriately. Demonstrating this would provide evidence that a trial with a much larger number of patients should be undertaken to assess safety and efficacy. The primary objective of the clinical phase of this trial is to determine the safety and efficacy of intravenous iron and erythropoietin in adult survivors of critical illness requiring treatment in the intensive care unit. In both phases the trial is parallel group, placebo-controlled, blinded, randomised trial that will allocate patients who are recovering in an ICU after an episode of critical illness and who are anaemic, in a 1:1 ratio, to intravenous iron and intravenous erythropoietin alfa in addition to standard care, or placebo in addition to standard care. The pilot phase was conducted at a single centre, the larger clinical trial is planned to be multicentre.
Interventions
The intervention group will receive a single dose of 1g intravenous ferric carboxymaltose infusion over two hours in 100ml of 0.9% saline, and a single dose of intravenous Epoetin alfa 40,000 IU (Eprex Janssen-Cilag Pty Ltd, Titusville, NJ, USA). Adherence to the intervention will be checked by observing the co-signed medical record of administration
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patient who has required ICU-level care for more than 48 hours 2. The treating clinician has determined that ICU discharge is appropriate or is likely to be appropriate in the next 24 hours 3. Haemoglobin <100g/L on the most recent usual care measurement within the last 24 hours
Exclusion criteria
1. Received IV iron therapy or ESA therapy in the last three months 2. Active cancer+ 3. The treating clinician believes that trial participation is not in the best interests of the patient 4. The treating clinician believes death during this hospital admission is inevitable 5. Any history of adverse reaction to IV iron or ESA therapy, or therapies derived from mammalian cells 6. Blood products are contraindicated 7. Receiving antibiotic therapy with a planned total therapy duration >10 days^ 8. Thromboembolism chemoprophylaxis is contraindicated 9. Resident in a nursing home or high-level chronic care facility 10. Pregnancy or breast feeding 11. Weight less than 50 kg 12. Porphyria 13. Previously enrolled in ITHRIVE
Outcome results
None listed