Acylcarnitine Profile After Intensive Care

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Care; Carnitine Metabolism Disturbances
• Intervention / Treatment: Diagnostic test: Serum acylcarnitine profiling

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: François Boemer, PhD; Email: f.boemer@chuliege.be
• Study Contact Backup: Name: Anne-Françoise Rousseau, MD, PhD; Phone Number: +3243667495; Email: afrousseau@chuliege.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • University Hospital of Liege
    • Contact: Anne-Françoise Rousseau, PhD; Phone Number: +3243667495; Email: afrousseau@chuliege.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

• Group short stayers: Critically ill patients with ICU length of stay of 2 days: patients admitted in ICU after a scheduled cardiac surgery with sternotomy
• Group long stayers: Critically ill patients with ICU length of stay of at least 7 days, whatever the critically illness

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Short stayers; Determination of the acylcarnitine profile during the 5 days following discharge of a short stay in ICU (maximum 2 days)	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).
Long stayers; Determination of the acylcarnitine profile during the year following discharge of a prolonged stay in ICU (7 days or more)	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acylcarnitine profile	Serum acylcarnitine profile	During the 5 first days following ICU discharge
Acylcarnitine profile	Serum acylcarnitine profile in long stayers	1 month following ICU discharge
Acylcarnitine profile	Serum acylcarnitine profile in long stayers	3 month following ICU discharge
Acylcarnitine profile	Serum acylcarnitine profile in long stayers	12 month following ICU discharge

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 30, 2021
• First Submitted That Met QC Criteria: October 30, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 25, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CARNUSI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No