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Search / Trial NCT07018843

Mitochondrial Assessment in Critical Ill Patients in Intensive Care

Launched by UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST · Jun 4, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Mitochondria Critical Illness Respirometry Muscle Biopsy Breath Test Oroboros Myoton Pro Muscle Ultrasound

ClinConnect Summary

This clinical trial is focused on understanding how well mitochondria, the energy-producing parts of our cells, are working in critically ill patients who are on ventilators in the intensive care unit (ICU). When someone is very sick, their mitochondria may not function properly, which can lead to serious complications like organ failure and weakness. The study aims to evaluate mitochondrial function using three different methods: a breath test after consuming a special amino acid, blood tests, and muscle samples. This research could help identify the best ways to assess mitochondrial health and find out how to improve it through nutrition or other therapies.

To participate, patients must be adults aged 18 or older, currently on a ventilator, and considered critically ill by their doctors. They need to be recruited within 48 hours of being intubated and expected to remain on a ventilator for over 72 hours. Participants will undergo non-invasive tests and may have a muscle biopsy, which involves taking a small sample of muscle tissue. This trial is important because it could lead to better ways to monitor and treat mitochondrial problems in critically ill patients, potentially improving their recovery and quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adults ≥ 18 years
  • Mechanically ventilated at time of recruitment
  • Defined as critically ill by the responsible clinician
  • Recruited within 48-hours of intubation
  • Likely to remain intubated and ventilated for \> 72-hours
  • Exclusion Criteria:
  • Patients \< 18 years
  • Patient is being treated on an end-of-life pathway or active treatment is likely to be withdrawn within 24-hours
  • Patient has significant liver dysfunction (Child-Pugh ≥ class 3)
  • Patient is not absorbing enterally (defined as 2 x NG aspirates of \> 500ml)
  • Known pregnancy or positive urinary pregnancy test on testing
  • Specific exclusion criteria for the muscle biopsy component of the study: Patients taking treatment dose anticoagulation, antiplatelet agents or with severe coagulopathy (or disease process leading to increased risk of bleeding) will be excluded from having a muscle biopsy taken as part of data collection.

About University Hospital Southampton Nhs Foundation Trust

University Hospital Southampton NHS Foundation Trust is a leading academic medical center located in the UK, renowned for its commitment to innovative healthcare and research. As a prominent sponsor of clinical trials, the Trust integrates cutting-edge research with clinical practice to advance medical knowledge and improve patient outcomes. With a diverse range of specialties, including cardiology, oncology, and pediatrics, the Trust actively collaborates with academic institutions and industry partners to conduct high-quality trials that adhere to rigorous ethical standards and regulatory guidelines. Its multidisciplinary approach ensures comprehensive patient care while fostering an environment of scientific inquiry and discovery.

Locations

Southampton, Hampshire, United Kingdom

Patients applied

0 patients applied

Trial Officials

Ahilanandan Dushianthan, MBBS MRCP PhD

Principal Investigator

University of Southampton; University Hospital Southampton

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported