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

Completed

• Conditions: blood poisoning; Sepsis; 10019815

• Registration Number: NL-OMON48792
• Lead Sponsor: Wageningen Universiteit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

*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 <30% and FEV1/FVC < 0.7)
• Patients with any stage of chronic or acute renal failure (pre-ICU admission,
pre-existent SOFA 0 for this SOFA element)
• Patients with any stage of chronic or acute liver failure (pre-ICU admission,
pre-existent SOFA 0 for this SOFA element)
• Patients supported with hemodialysis or continuous hemofiltration
• Patients diagnosed with diabetes Mellitus type I and II (pre ICU-admission)
• Patients not able to understand the Dutch language
• Patients currently participating in intervention research.
• Patients treated with any investigational agent within 12 months prior to
study treatment administration.
• Pregnant patients
• Patients who are <= 6 months postpartum pregnancy testing to the discretion of
the attending physician
• Patients whom consume more than 25 grams of ethanol daily (>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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is mitochondrial function in PBMCs.</p><br>

Secondary Outcome Measures

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