ISRCTN11364482已完成未知
IMPACCT: IMmune Profiling of ICU pAtients to address Chronic Critical illness and ensure healThy ageing
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Age =18 years
- •2. Admitted to an ICU for =48 hours and <120 hours (5 days)
- •3. Being (or has been) treated for suspected sepsis during this ICU admission:
- •3.1. Intravenous antibiotics to treat a known / suspected infection
- •3.2. Acute organ dysfunction
- •4. Has received organ support (any of the following):
- •4.1. Respiratory – any form of mechanical ventilation, non-invasive ventilation or high-flow nasal oxygen for =24h, OR
- •4.2. Cardiovascular – any intravenous continuous infusion of vasopressor or inotrope for =24h, OR
- •4.3. Renal – any form of continuous renal replacement therapy for =24 or acute and new intermittent haemodialysis with at least two episodes
- •5. Is expected to require ongoing care in an environment capable of providing organ support (eg and ICU or HDU) for at least one more calendar day
排除标准
- •1. Severe neutropenia (neutrophil count <0.5 x 10(9)/L) due to an underlying disease / treatment (but not sepsis)
- •2. Corticosteroids (intravenously or oral) of more than an equivalent dose of prednisolone 0.1mg/kg for at least 7 days within the past 30 days (not as part of sepsis management)
- •3. Use of therapeutic antibodies during this admission
- •4. Onco-haematological disease (eg, lymphoma, leukaemia, myeloma) treated within the 5 years before inclusion
- •5. Allogenic hematopoietic stem cell transplantation (regardless of timing)
- •6. Chemotherapy or immunotherapy within the last 6 months prior to inclusion date
- •7. Innate immune deficiency (eg, severe combined immunodeficiency)
- •8. Acquired immune deficiency (eg HIV or AIDS, any stage)
- •9. Receiving any other immunosuppressive therapy (eg anti-TNF therapies)
- •10. Patients with a ‘withdrawal of life-sustaining treatment’ decision, at time of inclusion
- •11. Moribund and not expected to survive 24 hours
- •12. Participation in an interventional study of immunomodulating therapy or any other unlicensed therapy
- •13. Pregnant or breastfeeding women
- •14. No social security insurance (France only)
- •15. Patients with restricted liberty, prisoners or under legal protection
- •16. Previously enrolled in IMPACCT
研究者
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