DRKS00003579招募中不适用
ong-term Immunological Sequelae in Sepsis-Survivors - LOSS
niversitätsklinikum JenaFriedrich-Schiller-UniversitätCenter for Sepsis Control and Care (CSCC)0 个研究点目标入组 59 人开始时间: 2012年2月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 59
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
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Key Inclusion Criteria Patient:
- •1.Sepsis, Severe sepsis, or septic shock based on the definitions by the ACCP/SCCM Consensus Conference:
- •- Sepsis: SIRS with documented infection
- •-->SIRS: presence of at least two criteria:
- •1) body temperature <36°C or >38°C),
- •2) tachycardia (>90 beats/min),
- •3) tachypnea (>20 breaths/min or PaCO2< 4.3kPa [32 mmHg], or need for mechanical ventilation),
- •4) white blood count <4000 cells/µl or >12,000 cells/µl.
- •--> Infection: defined by the International Sepsis Forum Consensus Conference on Definitions of Infection in the Intensive Care Unit.
- •-Severe sepsis: sepsis with at least one manifestation of inadequate organ perfusion or function:
- •1) hypoxemia (PaO2<10kPa),
- •2) metabolic acidosis (ph<7.30),
- •3) oliguria (<30 ml/hr),
- •4) lactic acidosis (serum lactate >2mmol/l),
- •5) acute alteration in mental status without sedation.
- •-Septic shock: sepsis with sustained decrease in systolic blood pressure (<90mmHg, or drop of 40 mmHg from baseline) despite fluid resuscitation and need for vasoactive amines to maintain adequate blood pressure.
- •2. Male or female persons, age =/> 18 years
- •3. Obtained oral and written consent
- •Key Inclusion Criteria Healthy Control:
- •1. Male or female persons, age =/> 18 years
- •2. Obtained oral and written consent
- •Key Inclusion Criteria SIRS Control:
- •1. SIRS based on the definitions by the ACCP/SCCM Consensus Conference:
- •-->SIRS: presence of at least two criteria:
- •1) body temperature <36°C or >38°C),
- •2) tachycardia (>90 beats/min),
- •3) tachypnea (>20 breaths/min or PaCO2< 4.3kPa [32 mmHg], or need for mechanical ventilation),
- •4) white blood count <4000 cells/µl or >12,000 cells/µl.
- •2. Male or female persons, age =/> 18 years
- •3. Obtained oral and written consent
排除标准
- •Key Exclusion Criteria Patient:
- •1. Systemic autoimmune disease, malignant hemopathy, HIV infection, transplantation, immunosuppressive medication (corticosteroids with >10mg prednisolone equivalent/day)
- •2. Chemo- or radiotherapy due to malignancy
- •3. End-stage chronic liver disease (Child-Pugh C)
- •4. End-stage chronic kidney disease (requiring renal replacement therapy)
- •5. Extracorporeal circulation and/or membrane oxygenation
- •6. Ischemic stroke or intracranial bleeding within last three months
- •7. Pregnancy and nursing
- •8. Participation in interventional study
- •Key Exclusion Criteria Healthy Control:
- •1.Sepsis, Severe sepsis, or septic shock based on the definitions by the ACCP/SCCM Consensus Conference at the time of screening or in medical history
- •2. Systemic autoimmune disease, malignant hemopathy, HIV infection, transplantation, immunosuppressive medication (corticosteroids with >10mg prednisolone equivalent/day)
- •3. Chemo- or radiotherapy due to malignancy
- •4. End-stage chronic liver disease (Child-Pugh C)
- •5. End-stage chronic kidney disease (requiring renal replacement therapy)
- •6. Extracorporeal circulation and/or membrane oxygenation
- •7. Ischemic stroke or intracranial bleeding within last three months
- •8. Pregnancy and nursing
- •9. Participation in interventional study
- •Key Exclusion Criteria SIRS Control:
- •1.Sepsis, Severe sepsis, or septic shock based on the definitions by the ACCP/SCCM Consensus Conference at the time of screening or in medical history
- •2. Systemic autoimmune disease, malignant hemopathy, HIV infection, transplantation, immunosuppressive medication (corticosteroids with >10mg prednisolone equivalent/day)
- •3. Chemo- or radiotherapy due to malignancy
- •4. End-stage chronic liver disease (Child-Pugh C)
- •5. End-stage chronic kidney disease (requiring renal replacement therapy)
- •6. Ischemic stroke or intracranial bleeding within last three months
- •7. Pregnancy and nursing
- •8. Participation in interventional study
研究者
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