Ceftriaxone to PRevent pneumOnia and inflammatTion aftEr Cardiac arresT (PROTECT): a Randomized-controlled Trial and Microbiome Assessment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Clinically-diagnosed Early-onset Pneumonia
研究概览
简要总结
Randomized-controlled trial and microbiome assessment to understand the risk-to-benefit ratio of prophylactic antibiotics (Ceftriaxone) vs placebo in patients with pneumonia and inflammation after cardiac arrest outside the hospital.
详细描述
Pneumonia is an infection of the lungs resulting in alveolar inflammation and fluid or purulent material accumulation. It is the most common infection after cardiac arrest occurring in up to 65% of patients treated with targeted temperature management. Pneumonia may result from aspiration during cardiopulmonary resuscitation (CPR), or by introduction of oropharyngeal flora into the lungs during airway management. Preventing infection after OHCA may: 1) reduce exposure to broad-spectrum antibiotics and subsequent collateral damage, 2) prevent hemodynamic derangements due to local and systemic inflammation, and 3) prevent an association between infection and morbidity and mortality. These benefits must be balanced with the risk for altering bacterial resistomes in the absence clinical infection. Accordingly, further study is warranted to understand the risk-to-benefit ratio of prophylactic antibiotics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The clinical team responsible for the participant (physicians, nurses and others) and involved with direct patient care will be blinded. Investigators will be blinded and the placebo will match the study drug. Outcomes Assessors will be blinded to treatment assignment during assessments of pneumonia and functional outcome.
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
- •≥18 years of age
- •Comatose (do not follow simple verbal commands)
- •Have any initial heart rhythm (shockable or non-shockable)
- •OHCA including the emergency department
排除标准
- •Name on opt-out list
- •In-hospital cardiac arrest
- •Interval >6 hours from ICU admission to study drug receipt
- •Preexisting terminal disease making 180-day survival unlikely
- •Refused informed consent
- •Emergent coronary artery bypass grafting
- •Anaphylaxis or angioedema to beta-lactam antibiotics (i.e., cephalosporins or penicillins)
- •Under legal guardianship or prisoner
- •Known colonization with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococcus (VRE)
- •Clinical bacterial infection prior to hospital admission defined as any one of the following:
- •Infectious prodrome preceding OHCA
- •Active course of antibiotics for infection prior to admission
- •Active infection documented in the electronic medical record
- •Family or surrogate endorsement of an active infection
研究组 & 干预措施
Prophylaxis
Antibiotic prophylaxis for 3 days. Antibiotic prophylaxis with Ceftriaxone 2 gm IV q12h for 3 days.
干预措施: Antibiotic prophylaxis (Drug)
No prophylaxis (placebo)
Standard care without antibiotic prophylaxis and treatment of infection if clinically warranted.
Administer antibiotics in response to infection.
干预措施: Standard of care without prophylaxis (Drug)
结局指标
主要结局
Clinically-diagnosed Early-onset Pneumonia
时间窗: 4 days
Percentage of Participants with Clinically-diagnosed Early-onset Pneumonia occurring \<4 days after initiation of mechanical ventilation
次要结局
- Microbiologically-confirmed Early-onset Pneumonia(4 days)
- Microbiologically-confirmed Late-onset Pneumonia(≥ 4 days)
- Clinically-diagnosed Late-onset Pneumonia(≥ 4 days)
- Non-pulmonary Infections(During the intervention and immediately after the intervention until hospital discharge, up to 6 months)
- ICU-free Days During Admission(28 days)
- Mechanical Ventilator-free Days During Admission(28 days)
- Death in the Hospital(During the intervention (3 days) and immediately after the intervention until subject death or hospital discharge, an average of 30 days)
- Functional Outcome at 6 Months Post-hospital Discharge(6 months post-hospital discharge)
- Clostridioides Difficile-associated Diarrhea(During the intervention and immediately after the intervention until death or hospital discharge)
- Type One Hypersensitivity Reactions(Three days)
- Participants With Gallbladder Disease(During the intervention and immediately after the intervention until death or hospital discharge)
研究者
David J. Gagnon
Critical Care Clinical Pharmacist
MaineHealth