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

The dynamics of epigenetic, metabolic and endocrine alterations during critical illness: a prospective cross-sectional study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN17621057
Enrollment
900
Registered
2015-12-09
Start date
2017-01-11
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical illness Other

Interventions

Biological samples will be collected from patients and controls after informed consent in order to perform the detailed studies as described. This includes the sampling of blood, mouth mucosa, hair, u

Sponsors

KU Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To study in detail, in preset time windows of ICU stay, the time course of the epigenetic, metabolic and endocrine alterations that develop in response to critical illness and to unravel potential underlying processes involved in these changes

Secondary

MeasureTime frame
1. Reanalysis of the time course of the alterations described in the primary objective 2. Within-subjects longitudinal analysis of changes for those patients who participate multiple times

Countries

Belgium

Contacts

Public ContactGreet Van den Berghe

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026