blood poisoning sepsis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Adult patients, aged between 18 and 85 years - Clinical suspicion of a pulmonary or urinary tract infection
Exclusion criteria
Exclusion criteria: - Congenital mitochondrial diseases - Renal transplant recipients - Patients on renal replacement therapy - Hepatic failure (Child Pugh C) - Hepatorenal syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In order to answer the primary objective, the following parameters will be measured in the group *hospitalized with infection*: Estimation of renal an systemic mitochondrial damage - Biomarkers for mitochondrial damage in plasma, urinary exosomes and urine - MtDNA copy number in plasma and urine - Oxidation of mtDNA in urinary exosomes and urine - MtDNA damage in urinary exosomes and urine Estimation of renal function - Serum creatinine level - Albumin/creatinine-ratio in urine - Estimated glomerular filtration rate (eGFR, MDRD-4 (44, 45)) - CKD (classified according to the KDIGO criteria (44, 45)) Mortality - In-hospital mortality - Long-term mortality Estimation of delirium (only in aged individuals) - Confusion assessment method (CAM) score within 24 hours and at day 4 Peripheral immune cells (functional status assessed by surface markers; only in aged individuals) - monocyte functional status and number (CD14/CD16) - NK-cell functional status and number (CD56) - T-cell functional status and number (CD3/CD45RO/CCR-7/CD27) - B-cell functional status and number (CD19) The following parameters will be measured in the group *matched control subjects*: Estimation of renal an systemic mitochondrial damage: - Biomarkers for mitochondrial damage in plasma, urinary exosomes and urine - MtDNA copy number in plasma and urine - Oxidation of mtDNA in urinary exosomes and urine - MtDNA damage in urinary exosomes and urine Estimation of renal function: - Serum creatinine level - Albumin/creatinine-ratio in urine - Estimated glomerular filtration rate (eGFR, MDRD-4 (44, 45)) - CKD (classified according to the KDIGO criteria (44, 45)) In addition to these parameters that will be collected to answer the primary study objectives, the following parameters will be collected in all subjects, from both groups: - Demographic characteristics (i.e. age, sex) - Smoking - Known pregnancy - Medication use - Cardiovascular and renal risk factors: hype | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the parameters that will be already collected to answer the primary study objectives, the following will be collected in the group *hospitalized with infection*: Measurement of serum cytokine levels (only in aged individuals) - The following cytokine levels will be measured: IL-1β, IL-6, TNF-a, IL-8, IL-10, IFN-a, IFN-β, IL-1RA, granzyme B, myeloperoxidase (MPO), IP-10 (CXCL10), PAI-1, IL12p40, tPA, paraoxonase-1, glycA and E-selectin. Measurement of cardiovascular events, co-morbidity, quality of life and functional status - Co-morbidity: Charlson comorbidity index - Functional status: Barthel Index, Lawton's Instrumental Activities of Daily Living (IADL), Short Physical Performance Battery and WHO-performance score - Quality of Life: EuroQol 5D 3L (EQ-5D-3L) Measurement of disease severity - Biomarkers of disease severity - Presumed source of infection - Treatment parameters - Vital signs at presentation, and after 3 hours - Clinical impression score at presentation, and after 3 hours - MEDS score at presentation, and after 3 hours - SOFA score at presentation, and after 3 hours - APACHE-II score at presentation, and after 3 hours - PIRO score at presentation, and after 3 hours - Vital signs at presentation, and after 3 hours - In-hospital mortality - Admittance to the ICU - Length of stay at ICU - Length of hospital stay - Progression to septic shock (i.e. persistent hypotension despite adequate fluid resuscitation) | — |
Countries
Netherlands
Outcome results
None listed