Post-Intensive Care Syndrome Recovery issues after Intensive Care admission
Conditions
Interventions
None listed
Sponsors
Ziekenhuis Gelderse Vallei
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) >=18 years of age 2) Medical research council (MRC) sum score of at least 24 and less than 48 3) Serum haemoglobin of at least 5.0 mmol/L 4) Admitted to an intensive care unit for at least 48 hours 5) exptected to be discharged from the ICU within 48 hours 7) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Known mitochondrial disease 2) Pre-existent muscle disease 3) Diabetes Mellitus 4) Life expectancy less than 6 months 5) Visibly high melanin content in the skin 6) Subcutaneous fat layer > 3cm covering the GA muscle (measured by ultrasound) 7) Coagulopathy (i.e. platelet count; 2.0 or recent treatment with therapeutic dosage of low molecular weight heparin) 8) Recent lower extremity surgery 9) Delirium (defined as a delirium observation screening scale (DOS) of at least three) 10) Deemed incompetent to provide well-considered informed consent by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study endpoint is the feasibility of 3 mm Bergstro*m biopsies of the vastus lateralis muscle and NIRS measurements of the gastrocnemius muscle in post-ICU patients. In order to determine this the following main parameters will be collected: - The acceptability for participation in the study, which is expressed as the number of eligible patients approached for participation in the study and the proportion of included patients as collected in a pre-screenings log. - Results from the questionnaire following NIRS measurements and the muscle biopsy, including pain rate, burden and willingness to undergo a secondary NIRS and/or muscle biopsy at hospital discharge. - The practical feasibility of NIRS measurement and biopsies of skeletal muscles in the post-ICU patient. - Reliability of NIRS assessment of mitochondrial capacity of the GA muscle in post-ICU patients as shown by reliable post-exercise mVO2 recovery curves (R2 > 0.90 by mono-exponential curve fitting). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include: - Amount of muscle tissue retrieved from a single 3 mm Bergström vastus lateralis muscle biopsy. - Muscle fibre type distribution and size of the vastus lateralis muscle sample of post ICU patients. - (Serious) adverse effects (SAE) following muscle biopsy and NIRS of skeletal muscles. - Quality of the muscle biopsy, as determined by a successful whole genome transcriptome analyses (RNA sequencing) - Re-oxygenation rate measured using NIRS after the release of the occlusion - Variation in NIRS-derived parameters between included subjects | — |
Countries
Netherlands
Contacts
Public ContactARH Van Zanten
Ziekenhuis Gelderse Vallei
Outcome results
None listed