医学
促红细胞生成素
安慰剂
临床终点
临床试验
随机对照试验
贫血
内科学
病理
替代医学
作者
Maxime Léger,Johann Auchabie,Martine Ferrandière,Elsa Parot‐Schinkel,Maëva Campfort,Emmanuel Rineau,Sigismond Lasocki
出处
期刊:Anaesthesia
[Wiley]
日期:2023-05-15
卷期号:78 (8): 979-987
被引量:4
摘要
Anaemia is common and associated with poor outcomes during and after critical illness. The use of erythropoietin to treat such anaemia is controversial with older studies showing mixed results. In this study, we aimed to evaluate the feasibility of performing a large multicentre randomised controlled trial of erythropoietin in this setting. We randomly allocated patients staying in the ICU for ≥ 72 h with haemoglobin ≤ 120 g.l-1 to either a weekly injection of erythropoietin (40,000 iu, maximum of five injections) or placebo (saline). The primary endpoint was feasibility (as measured by recruitment, randomisation and follow-up rates, and protocol compliance). Secondary endpoints included biological efficacy and clinical outcomes. Forty-two participants were recruited and randomly allocated, all participants received the allocated intervention, but one withdrew their consent and refused the use of their data, leaving 20 in the erythropoietin group and 21 in placebo group. Follow-up was completed for all patients who survived. The overall recruitment rate was 73.7% with 8.4 participants recruited on average per month. The last haemoglobin measured before hospital discharge (or death) was similar between the groups with a mean (SD) haemoglobin of 107 (21) vs. 95 (25) g.l-1 , mean difference (95%CI) 11 (-4-26), g.l-1 , p = 0.154. A large, multicentre randomised controlled trial of erythropoietin to treat anaemia in ICU patients is feasible and necessary to determine effects of erythropoietin on mortality in ICU anaemic patients.
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