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Evolution of mitochondrial dysfunction and hypermetabolic inflammatory status in septic Intensive Care Unit patients

Evolution of mitochondrial dysfunction and hypermetabolic inflammatory status in septic Intensive Care Unit patients - Mitochondria Intensive Care (MIC)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48792
Enrollment
60
Registered
2017-12-22
Start date
2018-02-23
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

blood poisoning Sepsis

Interventions

None listed

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Septic ICU patients: - 18+ years of age - Diagnosed with sepsis, not origniated from the urinary system Control patients: - Short-stay hospitalised patients (e.g. admission for one day), or patients admitted to the outpatient clinic of Gelderse Vallei Hospital - Free of sepsis - Metabolically healthy - Age (+/- 2 years) and gender-matched

Exclusion criteria

Exclusion criteria: *Only applicable for septic ICU patients **Comprehensively described in appendix of the protocol (All pre-ICU admission notes are not applicable to control patients), • Patients referred from another ICU • Patients with a haemoglobin level lower than 5,5 mmol/lL* • Patients with a history of solid organ or bone marrow transplant • Patients with active autoimmune disease involving the lung, heart, liver, small or large intestine, or neuromuscular system (e.g., myasthenia gravis, multiple sclerosis) AND currently requiring systemic immunosuppressive therapy • Patients whom experienced a significant medical or surgical event leading to hospitalization within the previous 6 months • Patients with a disease process (e.g., end-stage cancer) with a projected survival of less than 6 months (pre-ICU admission) • Patients whom received treatment with chemotherapy, immunotherapy or radiotherapy within the past 12 months • Patients with a family history of mitochondrial disease(s) ** • Patients with COPD Gold-Stadium III or IV or other severe respiratory disorders (FEV1 2.5 alcoholic beverages/day) • Patients with a history of drug abuse • Patients whom received treatment with corticosteroids or other immunosuppressive medications for active autoimmune disease involving the lung, heart, liver, small or large intestine, or neuromuscular system within 3 months prior to ICU-stay NOTE: Topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption) are permitted

Design outcomes

Primary

MeasureTime frame
The main study parameter is mitochondrial function in PBMCs.

Secondary

MeasureTime frame
The secondary study parameters are (a) parameters of hypermetabolic inflammatory status (concentrations of catabolic hormones, nutrients in serum/plasma, catabolic/pro-inflammatory cytokines and anabolic hormones), (b) mitochondrial dynamics and autophagy and (c) data from medical records.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)