ProMICstudy

• Conditions: Conditions required ventilator support in the Intensive Care Unit

• Registration Number: NL-OMON28381
• Lead Sponsor: Ziekenhuis Gelderse Vallei, Wageningen University, Karolinska Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified