Time course of epigenetic, metabolic and endocrine alterations during critical illness

Not Applicable

Active, not recruiting

• Conditions: Critical illness; Not Applicable

• Registration Number: ISRCTN17621057
• Lead Sponsor: KU Leuven

Brief Summary

2022 Interim results article in https://pubmed.ncbi.nlm.nih.gov/35584557/ (added 17/08/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-09
• Last Update Posted: 28 August 2023
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Observational
• Study Design: Not specified