A Randomized, Placebo-controlled, Blinded, Parallel-group Clinical Trial to Assess the Efficacy of N-acetylcysteine in Adults With Acute Infections or Sepsis and Evidence of Liver Dysfunction: the IMPACT-NAC Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 3
- 主要终点
- Days alive and out of hospital at 14 days post-randomization (DAOH-14)
研究概览
简要总结
The primary objective of the IMPACT-NAC trial is to assess the effects of N-acetylcysteine on survival and hospital length of stay in adults admitted to the emergency department with acute infection or sepsis and evidence of liver dysfunction.
The main question it aims to answer is: does N-acetylcysteine increase the number of days alive and out of the hospital within the first 14 days after enrolment in the trial?
To answer this question, we will conduct a randomized, double-blinded controlled trial of 360 participants.
Participants will be randomized to either N-acetylcysteine or placebo (normal saline without active drugs). This will be administered as an infusion during four hours within the first day of hospital admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Data Safety and Monitoring Board.
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
- •Age ≥18 years
- •Documented clinical suspicion of infection
- •Model for end-stage liver disease (MELD) score ≥9
排除标准
- •Admitted to hospital >24 hours before randomization
- •Any previous severe anaphylaxis
- •Other known allergy to N-acetylcysteine
- •Ongoing treatment with N-acetylcysteine at randomization
- •Documented clinical suspicion of bile duct obstruction
- •Refractory circulatory shock
- •Informed consent not obtainable
- •Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments
- •Involuntary admission under the psychiatric law
- •Expected initiation of palliative care within 48 hours of randomization
- •Ongoing treatment with nitroglycerin
- •Any other condition deemed by the investigator to compromise patient safety or trial integrity (e.g., severe coagulopathy, uncontrolled bleeding, diabetic ketoacidosis)
研究组 & 干预措施
Placebo (normal saline)
N-acetylcysteine
干预措施: N-Acetylcysteine (NAC) Treatment (Drug)
结局指标
主要结局
Days alive and out of hospital at 14 days post-randomization (DAOH-14)
时间窗: Assessed 14 days post-randomization
次要结局
- Health-related quality of life (HRQoL) at day 180 using EQ-5D-5L(Assessed 180 days post-randomization)
- Admission to an intensive care unit (ICU) within 14 days of admission(Assessed at 14 days post-randomization)
- All-cause mortality at day 180(Assessed at 180 days post-randomization)
- Duration of antibiotic therapy from randomization to day 14(Assessed at 14 days post-randomization)
- Time to clinical stability(Assessed at 14 days post-randomization)
- Number of participants with one or more serious adverse event within 14 days of randomization(Assessed 14 days post-randomization)
- Days alive and out of hospital at 30 days post-randomization(Assessed 30 days post-randomization)
- All-cause mortality at 14, 30 and 180 days after inclusion(Assessed at 14, 30 and 180 days post-randomization)
- ICU admission within 14 and 30 days of randomization(Assessed at 14 and 30 days post-randomization)
- Hospital length of stay within 14 and 30 days of randomization(Assessed at 14 and 30 days post-randomization)
- Health related quality-of-life at 180 days post-randomization (EQ-5D-5L)(Assessed 180 days post-randomization)
- Duration of antibiotic therapy within 14 and 30 days of randomization(Assessed at 14 and 30 days post-randomization)
- Escalation of antibiotic therapy within 14 and 30 days of randomization(Assessed at 14 and 30 days post-randomization)
研究者
Theis S. Itenov
Clinical Associate Professor and Specialist Physician
University Hospital Bispebjerg and Frederiksberg