NCT07273071尚未招募4 期
Individualized Multiplex Pathophysiological Treatment of Severe Acute Infections (IMPACT): A Randomized, Open-Label Clinical Trial to Assess Whether an Individualized Treatment Strategy Aimed at Preventing Organ Dysfunction Can Reduce Mortality and Decrease Hospital Length of Stay in Patients With Severe Acute Infections
Theis S. Itenov2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 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 goal of the IMPACT trial is to determine whether an individualized treatment strategy, initiated at admission to the Emergency Department, can reduce hospitalizations and improve survival among patients with sepsis. To address this question, we will enroll 300 participants in a randomized controlled trial.
All participants will undergo an extended clinical assessment. Those randomized to the individualized treatment arm may receive up to five targeted interventions, depending on the findings of this assessment.
The targeted interventions are:
- Continuous positive airway pressure (CPAP) to support breathing and help prevent respiratory problems in participants who show signs of breathing difficulties on ultrasound.
- Ketone ester, a nutritional supplement, to help support heart function in participants who show signs of heart strain on ultrasound.
- N-acetylcysteine, an antioxidant treatment, to help protect the liver in participants with early signs of liver stress.
- Intravenous iron to help prevent or treat anemia in participants who show signs of low iron levels.
- Hydrocortisone, a steroid, to help stabilize the immune system in participants with signs of immune overactivation.
Participants randomized to the control group will receive standard-of-care according to local clinical guidelines.
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
- None
盲法说明
The person performing the EQ-5D-5L questionnaire is masked to treatment allocation. The DSMB is masked to treatment allocation.
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
- •Suspected acute infection within 72 hours of admission, defined as (1) having samples collected for bacterial isolation and/or (2) being initiated on antibiotic therapy
- •Documented clinical suspicion of infection
- •Admitted to the hospital with an expected duration greater than 24 hours
- •Sequential organ failure assessment (SOFA) score ≥2
排除标准
- •Informed consent following inclusion expected to be unobtainable
- •Inability to read and understand Danish to a degree that allows valid informed consent and completion of trial assessments
- •Pregnant or breastfeeding patients
- •Involuntary admission under the psychiatric law
- •Admitted to hospital or undergone surgery during the 14 days prior to admission
- •Expected initiation of palliative care within 48 hours of randomization
- •Previous randomization into the current trial
- •Admitted to ICU or expected transfer to ICU within 2 hours
- •Previous severe anaphylaxis
- •Any other condition deemed by the investigator to compromise patient safety or trial integrity (e.g., severe coagulopathy, uncontrolled bleeding, diabetic ketoacidosis)
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
- 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
研究点 (2)
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