NCT02706275已完成不适用
Pilot Randomized Trial of External Warming in Critically Ill Adult Septic Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Monocyte human leukocyte antigen (mHLA-DR) expression
研究概览
简要总结
The purpose of this study is to determine whether externally warming critically ill afebrile adult septic patients will improve indices of immune function and/or clinical outcomes.
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
- Single (Outcomes Assessor)
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
- •Admitted to a surgical or medical intensive care unit
- •Age greater than 18 years
- •Diagnosis of sepsis within 24 hours of enrollment
- •Requirement for mechanical ventilation with expected duration of mechanical ventilation > 48 hours
- •Goal Richmond Agitation Sedation Scale (RASS) < 0
- •Maximum baseline temperature (within previous 24 hours) < 38.3°C
排除标准
- •Treatment with chemotherapy within 6 months of enrollment
- •Treatment with corticosteroids at a dose > 300 mg/day hydrocortisone (or equivalent)
- •History of solid organ transplant on any immunosuppression medication
- •History of immunological disease
- •History of chronic infection with hepatitis B or C virus
- •History of acute stroke, acute coronary syndrome, or severe head injury requiring osmotic therapy within 7 days prior to enrollment
- •History of multiple sclerosis
- •Contraindications to both bladder or esophageal core temperature monitors or to forced air warming blankets
- •Moribund status
- •Sepsis without source control
研究组 & 干预措施
Warming Group
Experimental
External warming via forced air warming
干预措施: External warming (Other)
Control Group
No Intervention
Standard of care body temperature management
结局指标
主要结局
Monocyte human leukocyte antigen (mHLA-DR) expression
时间窗: 48 hours hours following the start of the intervention period
次要结局
- Number of patients who acquire nosocomial infections(30 days after diagnosis of sepsis)
- Number of patients in whom the intervention is stopped early secondary to hemodynamic changes related to the intervention(Through study completion, 2 years)
- Interferon (IFN)-gamma production(48 hours following the start of the intervention period)
- Mortality(28 days)
研究者
研究点 (1)
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