Iron and erythropoietin to heal and recover after intensive care (ITHRIVE): A pilot randomised clinical trial.

Litton, Edward; French, Craig; Herschtal, Alan; Stanworth, Simon; Pellicano, Susan; Palermo, Anne Marie; Bates, Samantha; Van Der Laan, Sarah; Eroglu, Ege; Griffith, David; Shah, Akshay

Litton, Edward; French, Craig; Herschtal, Alan; Stanworth, Simon; Pellicano, Susan; Palermo, Anne Marie; Bates, Samantha; Van Der Laan, Sarah; Eroglu, Ege; Griffith, David; Shah, Akshay.

Afiliación

Litton E; Intensive Care Unit, Fiona Stanley Hospital, Perth 6150, WA, Australia.
French C; School of Medicine, University of Western Australia, 6009, WA, Australia.
Herschtal A; Intensive Care Unit, Western Health, Melbourne, 3021, VIC, Australia.
Stanworth S; School of Public Health and Preventative Medicine, Monash University, 4/553 St Kilda Road, Melbourne, VIC, Australia.
Pellicano S; Haematology & Transfusion Medicine, John Radcliffe Hospital, Oxford UK.
Palermo AM; Intensive Care Unit, Fiona Stanley Hospital, Perth 6150, WA, Australia.
Bates S; Intensive Care Unit, Fiona Stanley Hospital, Perth 6150, WA, Australia.
Van Der Laan S; Intensive Care Unit, Western Health, Melbourne, 3021, VIC, Australia.
Eroglu E; Intensive Care Unit, Fiona Stanley Hospital, Perth 6150, WA, Australia.
Griffith D; Intensive Care Unit, Fiona Stanley Hospital, Perth 6150, WA, Australia.
Shah A; Critical Care and Anaesthesia, Usher Institute, Edinburgh Medical School, Molecular, Genetic, and Population Health Sciences, The University of Edinburgh, UK.

Crit Care Resusc ; 25(4): 201-206, 2023 Dec.

Article en En | MEDLINE | ID: mdl-38236513

ABSTRACT

ABSTRACT

Objective:

To determine the feasibility of a pivotal randomised clinical trial of intravenous (IV) iron and erythropoietin in adult survivors of critical illness with anaemia requiring treatment in the intensive care unit.

Design:

An investigator-initiated, parallel group, placebo-controlled, randomised feasibility trial.

Setting:

A tertiary intensive care unit (ICU) in Perth, Western Australia.

Participants:

Adults with anaemia (haemoglobin <100 g/L), requiring ICU-level care for more than 48 h, and likely to be ready for ICU discharge within 24 h.

Interventions:

A single dose of IV ferric carboxymaltose and Epoetin alfa (active group) or an equal volume of 0.9% saline (placebo group). Main outcome

measures:

Study feasibility was considered met if the pilot achieved a recruitment rate of ≥2 participants per site per month, ≥90% of participants received their allocated study treatment, and≥ 90% of participants were followed up for the proposed pivotal trial primary outcome - days alive and at home to day 90 (DAH90).

Results:

The 40-participant planned sample size included twenty in each group and was enrolled between 1/9/2021 and 2/3/2022. Participants spent a median of 3.4 days (interquartile range 2.8-5.1) in the ICU prior to enrolment and had a mean baseline haemoglobin of 83.7 g/L (standard deviation 6.7). The recruitment rate was 6.7 participants per month [95% confidence interval (CI) 4.8-9.0], DAH90 follow-up was 100% (95% CI 91.2%-100%), and 39 (97.5%, 95% CI 86.8%-99.9%) participants received the allocated study intervention. No serious adverse events were reported.

Conclusion:

The iron and erythropoietin to heal and recover after intensive care (ITHRIVE) pilot demonstrated feasibility based on predefined participant recruitment, study drug administration, and follow-up thresholds.

Palabras clave

Anaemia; Critical care; Intensive care unit

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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials Idioma: En Revista: Crit Care Resusc Asunto de la revista: TERAPIA INTENSIVA Año: 2023 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Países Bajos

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