Clock Genes in Patients With Refractory Septic Shock (SeptiClock) - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of circadian regulation
研究概览
简要总结
Despite large efforts trying to improve diagnostic and therapy of sepsis have been made over the last decade (e.g. initiation of the Surviving Sepsis Campaign, defining evidence based sepsis therapy bundles) the mortality of septic shock remains high and causes high socioeconomical burden of disease.
The purpose of this pilot study is to evaluate the design and conduct of a projected full scale clinical trial.
详细描述
A functional clock is required for induction of several proinflammatory genes, not shown in septic patient settings, yet.
Clock genes are involved in modulating the activity of several transcription factors that are important regulators of immune functions (e.g. HIF1-α, STAT1, STAT3, and NF-κB) (Bellet MM et al., 2013).
Furthermore, polymorphisms such as rs7221412, a common polymorphism near period homolog 1 (PER1), was associated with the timing of activity rhythms and also showed a suggestive time-dependent relationship with both cerebral cortex and monocytes PER1 expression and an association with time of death (Lim ASP et al., 2012).
This explorative project is a pilot study. First data are generated for the assessment of the circadian system in patients with septic shock.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male and female patients with age 18 years and above,
- •Patient at intensive care units (8i, 9i and 1i at Charité - University Medicine Berlin , Campus Virchow- Klinikum),
- •Septic shock (ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) consensus definitions) AND Norepinephrine dosage of >0.3 μg/kg/min for at least 2 hours
排除标准
- •Pregnant or lactating female patient,
- •Participation in another interventional study (30 days before study inclusion and during study participation),
- •Acute leucemia,
- •Severe leukocytosis (>50,000/nl),
- •Severe thrombocytopenia (<5,000/nl),
- •Autoimmune disease with systemic medication of ≥10 mg prednisolone equivalent or previous transplantation,
- •Patients receiving interferon therapy (last 14 days),
- •Patients with known hypersensitivity GM-CSF or known antibodies against GM-CSF, yeast-derived products or any component of the study medication,
- •Ongoing (concomitant) chemotherapy or radiotherapy for malignancy,
- •Acute pulmonary embolism or acute myocardial infarction within last 72 hours,
- •Cardiopulmonary resuscitation within last 7 days,
- •Moribund patient (life expectancy <72 hrs.),
- •Presence of a do-not-resuscitate or do-not-intubate order,
- •Known human immunodeficiency virus (HIV) infection or chronic viral hepatitis
- •Lacking willingness to save and hand out data within the study
- •Accommodation in an institution due to an official or judicial order
- •The informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time
- •Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
结局指标
主要结局
Assessment of circadian regulation
时间窗: These parameters are measured during intensive care unit stay, for a maximum of 3 days
Circadian regulation by expression of clock genes
次要结局
- Sequential Organ Failure Assessment (SOFA)(They are measured until the end of intensive care unit stay - or, for a maximum of 28 days.)
- Time on mechanical ventilation(They are followed up until the end of intensive care unit stay - or, for a maximum of 28 days)
- Hospital length of stay(Participants will be followed for the duration of intensive care stay, an expected average of 5 weeks)
- Simplified Acute Physiology Score (SOFA II)(They are measured until the end of intensive care unit stay - or, for a maximum of 28 days.)
- Therapeutic Intervention Scoring System (TISS-28)(They are measured until the end of intensive care unit stay - or, for a maximum of 28 days.)
- Light levels (lux)(Light levels are measured until the end of intensive care unit stay - or, for a maximum of 28 days)
- Cortisol(This parameter is measured in ng/ml during intensive care unit stay, for a maximum of 3 days)
- Intensive care unit length of stay(Participants will be followed for the duration of intensive care stay, an expected average of 4 weeks)
- Melatonin(This parameter is measured in pg/ml during intensive care unit stay, for a maximum of 3 days)
- Cognitive function(Up to 3 and 6 months)
- Mortality(6 months after intensive care unit discharge)
- Light frequencies(Light frequencies are measured until the end of intensive care unit stay - or, for a maximum of 28 days)
- Quality of life(Up to 3 and 6 months)
- Multiplex-Genexpression analysis(These parameters are measured during intensive care unit stay, for a maximum of 3 days)
研究者
Claudia Spies
Department of Anesthesiology and Intensive Care Medicine, CVK/CCM, Charité - University Medicine Berlin
Charite University, Berlin, Germany