Acylcarnitine Profile After Intensive Care

Critical Care Clinical Trial

Official title:

Acylcarnitine Profile After Intensive Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05115734
• Other study ID #: CARNUSI
• Status: Recruiting
• Start date: November 3, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2023
• Source: University of Liege
• Contact: Anne-Françoise Rousseau, MD, PhD
• Phone: +3243667495
• Email: afrousseau[@]chuliege.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to compare the acylcarnitine profile of critically ill survivors of a prolonged stay in ICU with the profile of survivors of short ICU length of stay. The second aim is to assess the evolution of the acylcarnitine profile over time in survivors of a prolonged ICU stay.

Description:

In a retrospective analysis focused on survivors of an ICU stay of 7 days or more, we showed that during the week following discharge, carnitine deficiency was rare, but acylcarnitine profile was altered, with an abnormal acylcarnitine/carnitine ratio in more than 25% of the population. Carnitine has a key role in cellular energy metabolism and is a a biomarker of the mitochondria function. Moreover, mitochondrial function is proven to be severely impaired in critically ill patients and mitochondrial dysfunction has been linked to post-ICU disorders. In this context, it is relevant to study the evolution over time of the acylcarnitine profile in ICU survivors of a prolonged ICU stay. It is also relevant to compare the same profile between survivors of a prolonged and a shorter ICU stay.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Group short stayers: ICU length of stay of 2 days
• Group long stayers: ICU length of stay of at least 7 days Exclusion criteria: patient refusal

Related Conditions & MeSH terms

• Critical Care

Intervention

Diagnostic Test:
• Serum acylcarnitine profiling
Blood samples are collected through a central or peripheral venous line placed for clinical use, or through venous punction. Blood will be drawn into a serum gel tube (BD Vacutainer, Becton, Dickinson and Company, Franklin Lakes, NJ, USA), before being centrifuged (3500 rpm, 15 min, 4°C). Supernatant will be frozen at -20°C and stored for later analysis. Serum ACs concentrations (free carnitine (C0), C2-, C3-, C3DC-, C4-, C4-OH-, C4-DC-, C5-, C5:1-, C5-OH-, C5DC-, C6-, C6-OH-, C6-DC-, C8-, C8:1-, C10-, C10:1-, C10:2-, C12-, C12:1-, C14-, C14:1-, C14:2-, C14-OH-, C16-, C16:1-, C16-OH-, C16-1-OH-, C17-, C18- ,C18:1-, C18:2-, C18-OH-, C18:1-OH-, C18:2-OH-carnitine) will be determined on a TQ5500 tandem mass spectrometer (Sciex, Framingham, MA, USA).

Locations

Country	Name	City	State
Belgium	University Hospital of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acylcarnitine profile	Serum acylcarnitine profile	During the 5 first days following ICU discharge
Primary	Acylcarnitine profile	Serum acylcarnitine profile in long stayers	1 month following ICU discharge
Primary	Acylcarnitine profile	Serum acylcarnitine profile in long stayers	3 month following ICU discharge
Primary	Acylcarnitine profile	Serum acylcarnitine profile in long stayers	12 month following ICU discharge