NCT05944458已完成4 期
Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients: A Double-Blind Randomized Placebo-Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- difference in incidence of LIT between patients who received NAC and patients who didn't.
研究概览
简要总结
- Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients.
- Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets.
详细描述
Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't.
- Primary outcome definition: Defined as platelets < 150000 OR decrease > 50% of baseline platelets.
- Secondary outcome: difference in Time to onset of LIT and time to recovery between the 2 groups. Blood products transfusion, bleeding, length of stay, and in-hospital mortality incidence between 2 groups.
- Secondary outcome definitions: after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts > 70% of baseline values.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 18 years)
- •Admitted to the Intensive Care Unit (ICU)
- •Candidates for intravenous linezolid therapy for ≥ 48 hours
排除标准
- •Baseline platelet count < 50 × 10⁹/L
- •Diagnosis of malignancy
- •Receipt of any chemotherapeutic agent within the past 6 months
- •Positive COVID-19 RT-PCR test at admission
- •Diagnosis of immune thrombocytopenia
- •Presence of splenomegaly
- •Presence of liver cirrhosis
- •Presence of hepatitis C
- •Refusal to provide informed consent
研究组 & 干预措施
N-acetylcysteine group
Active Comparator
Generic name: N-acetylcysteine.
- Trade name: Fluimucil.
- Company: Zambon.
- Dosage form: ampoules for intravenous administration.
- Dose: 600mg taken every 12 hours daily with a fixed dose as there is no need for renal or hepatic adjustment, starting with the inception of linezolid therapy.
- Duration: for 14 days post linezolid discontinuation or until ICU discharge, whichever came first.
干预措施: N acetyl cysteine (Drug)
Standard of care
Placebo Comparator
They will receive standard of care (Platelets monitoring daily, linezolid discontinuation if platelet count less than 50000 or clinically appropriate and platelet transfusion according to the institutional protocol) plus placebo (20 ml normal saline twice daily)
干预措施: Placebo (Drug)
结局指标
主要结局
difference in incidence of LIT between patients who received NAC and patients who didn't.
时间窗: From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.
Defined as platelets \< 150000 OR decrease \> or = 50% of baseline platelets.
次要结局
- Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups.(From start linezolid until ICU discharge)
- Difference in time to thrombocytopenia onset between the 2 groups(From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first)
- Difference in time to platelet recovery between the 2 groups(From thrombocytopenia onset to recovery, assesed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first)
研究者
Mohamed Abdeltawab
Clinical pharmacist
Helwan University
研究点 (1)
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