Temperature Optimization in Afebrile Septic PatienTs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Proteomics
研究概览
简要总结
The goal of this interventional study is to learn if external warming works to treat patients with a serious systemic infection (i.e. sepsis) that do not have fever. These patients have a higher risk of dying than patients with fever. It is possible that these patients might benefit from artificial external warming with the means to increase body temperature. It is unknown what the mechanism is, but it might be related to the immune system and how the body manages blood pressure and perfusion.
The main questions to answer are:
- Does external warming of the body influence certain inflammatory proteins in the blood?
- Does external warming of the body influence prognosis and/or clinical condition? Researchers will compare external warming to standard clinical practice to see if external warming works to treat sepsis without fever.
Participants will:
- receive treatment with external warming or treatment according to clinical practice
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
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
- •Sepsis according to the SEPSIS-3 definition
- •Sedated and intubated
- •Highest temperature < 38,3 degrees Celsius
排除标准
- •A potential participant who meets any of the following criteria will be excluded from participation in this study:
- •Patients with immunologic diseases:
- •human immunodeficiency virus
- •neutropenia
- •history of chronic infection with hepatitis B or C virus
- •Patients using immune suppressing medications:
- •treatment with corticosteroids at a dose of > 300 mg/day hydrocortisone or equivalent at the time of enrollment;
- •Tacrolimus
- •Mycophenolate mofetil
- •Ciclofosfamide
- •Patients with a contraindication for therapeutic hyperthermia:
- •cardiac arrest
- •acute ischemic stroke
- •acute coronary syndrome
- •traumatic brain injury
- •spinal cord injury
- •sickle cell disease
- •multiple sclerosis
- •Pregnancy
- •Moribund patients (expected death within 48 hours)
- •Contraindications to forced air warming devices per manufacture instructions (i.e. ischemic limbs)
研究组 & 干预措施
External Warming
Intervention with External Warming
干预措施: External Warming (Other)
Control
Control group according to standard clinical practice
结局指标
主要结局
Proteomics
时间窗: From enrollment until 48 hours after enrollment
Delta proteomics pathway analysis between baseline and after 48 hours of enrollment.
次要结局
- Mortality(30 days)
- Organ failure(until end of ICU stay, approximately 30 days)
- Length of ICU stay(until end of ICU stay, approximately 30 days)
- Nosocomial infections(until end of ICU stay, approximately 30 days)
- Length of hospital stay(until discharge, approximately 30 days until 3 months)
- Microcirculation(From enrollment until 48 hours after enrollment)
- Hemodynamics(From enrollment until 48 hours after enrollment)
- Mitochondrial oxygen tension(From enrollment until 48 hours after enrollment)
研究者
Matt Harmon
Principal Investigator
Erasmus Medical Center