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ProMICstudy

The impact of high versus standard enteral protein provision on PGE2 levels, autophagy flux and mitochondrial function following Intensive Care admission: combined sub-studies of the PRECISe trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28381
Enrollment
60
Registered
2021-06-30
Start date
2021-08-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Conditions required ventilator support in the Intensive Care Unit

Interventions

Blood sampling

Sponsors

Ziekenhuis Gelderse Vallei, Wageningen University, Karolinska Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in the PRECISe study, a potential subject must meet all of the following criteria: 1. Adult = 18 years-old admitted to the ICU 2. Unplanned ICU admission 3. Invasive mechanical ventilation initiated <24 hours of ICU admission 4. Expected ICU stay on ventilator support of = 3 days There are no additional inclusion criteria for this substudy.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in the PRECISe study: 1. Contraindication for enteral nutrition 2. Moribund or expected withholding of treatment 3. Kidney failure with “no dialysis”-code on admission 4. Hepatic encephalopathy 5. Body-mass index <18 kg/m² Additional exclusion criteria for this set of sub-studies: 1. Current NSAID use 2. Use of chronic corticosteroid or other immunosuppressive medication prior to current hospital admission. 3. Current use of fish oil supplements 4. Haemoglobin level lower than 5,5 mmol/lL 5. Patients referred from another ICU 6. 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 7. Patients who experienced a significant medical or surgical event prior to current hospital admission leading to hospitalization within the previous 6 months 8. A disease process (e.g., end-stage cancer) with a projected survival of less than 6 months (pre-ICU admission) 9. Received treatment with chemotherapy, immunotherapy or radiotherapy within the past 12 months 10. Family history of mitochondrial disease(s) or genetic autophagy diseases. 11. COPD Gold-Stadium III or IV or other severe respiratory disorders (FEV1 <30% and FEV1/FVC < 0.7) (pre-ICU admission) (15) 12. Any stage of chronic or acute renal failure (pre-ICU admission, pre-existent SOFA 0 for this SOFA element) 13. Any stage of chronic or acute liver failure (pre-ICU admission, pre-existent SOFA 0 for this SOFA element) 14. Patients supported with haemodialysis or continuous hemofiltration 15. Diabetes Mellitus type I and II (pre ICU-admission) 16. Patients not able to understand the Dutch language 17. Treated with any investigational agent within 12 months prior to study treatment administration. 18. Patients who are = 6 months postpartum pregnancy testing to the discretion of the attending physician 19. (History of) drug abuse

Design outcomes

Primary

MeasureTime frame
•To investigate the effect of high vs standard enteral protein provision on the regulation of intramuscular autophagy flux in ICU patients •To investigate the effect of high vs standard enteral protein provision on the evolution of mitochondrial dysfunction and hypermetabolic inflammatory status in ICU patients •To uncover a possible association between PGE2, protein intake and the course of disease in ICU patients

Secondary

MeasureTime frame
• To investigate the localization of the autophagy block and relation of autophagy changes to nutrient levels in the serum • To investigate if and how parameters of the hypermetabolic inflammatory state are related to the progression of mitochondrial function in ICU patients • To investigate if and how the progression of mitochondrial function is related to physical performance and clinical outcomes in ICU patients • To investigate how mitochondrial dynamics progress over time and how this is associated with mitochondrial function in ICU patients • To investigate the oxylipins profile measured by LCMSMS and lipopolysaccharide (LPS) levels • To investigate how the prostaglandin levels are related to the inflammatory levels of cytokines. • To investigate how oxylipin levels associate with changes in autophagy and mitochondrial function and vise versa.

Contacts

Public ContactJonathan Huising

Ziekenhuis Gelderse Vallei

jhuising@zgv.nl0318434343

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)