ISRCTN17621057进行中（未招募）未知
The dynamics of epigenetic, metabolic and endocrine alterations during critical illness: a prospective cross-sectional study
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- KU Leuven
- 入组人数
- 374
研究概览
简要总结
2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35584557/ (added 17/08/2023)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Patients:
- •All adult/senior patients at the surgical and medical intensive care units are eligible
- •2. Controls:
- •A control group of volunteers who have not been critically ill, but have similar comorbidities as the critically ill patients will be recruited to match demographically with the patient group
排除标准
- •1. Patients:
- •1.1. General:
- •1.1.1. Age younger than 18 years
- •1.1.2. Readmission to ICU (unless within 48 hrs)
- •1.1.3. Declined participation
- •1.1.4. DNR code
- •1.1.5. Patients with HIV
- •1.1.6. Chronic systemic treatment with glucocorticoids prior to ICU admission (added 12/09/2018: patients who did receive chronic systemic treatment with glucocorticoids prior to ICU admission will be recruited separately to allow investigation of the impact of prior chronic systemic glucocorticoid treatment)
- •1.2. Blood sampling: absence of arterial line
- •1.3. Mouth mucosa sampling: normal mouth mucosa not accessible (e.g. post-tumor resection)
- •1.4. Neuromuscular evaluation:
- •1.4.1. General:
- •1.4.1.1. Patients with neuromuscular disorders identified prior to ICU admission / unable to walk without assistance (wheelchair, walking stick, arm support) prior to ICU admission
- •1.4.1.2. Patients with a neuromuscular disorder as reason for ICU admission
- •1.4.2. Muscle biopsy: increased bleeding risk
- •1.4.2.1. Platelet count below 50000/mm3 and/or PT below 40%
- •1.4.2.2. Known coagulation disorders
- •1.4.2.3. Use of anti-coagulation or thrombolytic agents
- •1.4.3. Muscle force by MRC sum score:
- •1.4.3.1. No muscle biopsy
- •1.4.3.2. Patient not awake/cooperative (*)
- •1.4.4. Hand grip strength
- •1.4.4.1. No muscle biopsy
- •1.4.4.2. Patients not awake/cooperative (*)
- •1.4.4.4. Medical Research Council (MRC) score for forearm flexion or wrist extension below 3
- •1.4.5. Electromyography / nerve conduction studies / direct muscle stimulation
- •1.4.5.1. No muscle biopsy
- •(*) patients who give a biopsy but are not awake/cooperative at the time of sampling will be screened for awakening/cooperation up until two days later for MRC sum scoring and hand grip strength
- •1.5. Fat biopsy: increased bleeding risk:
- •1.5.1. Platelet count below 50000/mm3 and/or PT below 40%
- •1.5.2. Known coagulation disorders
- •1.5.3. Use of anti-coagulation or thrombolytic agents
- •2. Controls:
- •2.1. General
- •2.1.1. Age younger than 18 years
- •2.1.2. Previous ICU stay (except coronary care unit stay)
- •2.2. Blood sampling: known severe coagulation disorders (e.g. hemophilia)
- •2.3. Mouth mucosa sampling: normal mouth mucosa not accessible (e.g. post-tumor resection)
- •2.4. Muscle and fat biopsy:
- •2.4.1. Controls with acute or chronic neuromuscular disorders or unable to walk without assistance (wheelchair, walking stick, arm support) will be excluded for muscle biopsy
- •2.4.2. Increased risk of bleeding:
- •2.4.2.1. Known coagulation disorders
- •2.4.2.2. Use of anti-coagulation
- •2.5. Muscle force / electrophysiology / direct muscle stimulation: no muscle biopsy
研究者
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