Mitochondrial Function in the Peri-operative Setting: an Observational Study

NCT05925998 | Not Yet Recruiting

• 1 other identifier: RHM CRI0430
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Complications after surgery are common and a burden for patients and health services. Therefore it is important that clinicians improve surgical outcomes. Mitochondria are the part of the body's cells that manage energy. Research has already shown that how our body's mitochondria behave can predict who survives in intensive care patients. The investigators think this could also predict who is more likely to develop complications after surgery. Therefore a study has been designed to find out if changes in mitochondria are related to postoperative complications. This will help doctors improve how they prepare patients for surgery and potentially how they manage their treatment, and result in improving outcomes for patients after surgery. This study will recruit patients scheduled for major abdominal surgery as part of their treatment. The investigators will take samples of breath, blood and muscle to measure changes in mitochondria from the day before surgery to 7 days postoperatively. The muscle samples will only be taken when the patient is asleep having their operation. These samples will be used to analyse mitochondria. This study will be in two phases. Phase 1 is a pilot of up to 10 patients focussed on feasibility. Following this there will be an interim data analysis. The results may allow further optimisation to reduce the patient burden, eg reduction in sampling frequency, or avoiding need for muscle biopsy. The second phase will be a full cohort study of up to 40 patients, focussed on association of mitochondrial markers with clinical outcomes, such as postoperative complications, oxygen levels, pain, confusion and length of intensive care stay. The results of this study could improve how doctors select and prepare patients for surgery. It may also affect how doctors manage their treatment during and after operations. This could result in reducing complications and illness burden for patients after surgery.

Conditions

Mitochondrial; Perioperative Complication; Surgery-Complications

Outcome Measures

Primary Outcomes (3)

• Number of eligible patients screened

  Number of eligible patients screened

  Through study completion, an average of 3 years

• Number of eligible patients consented

  Number of eligible patients consented

  Through study completion, an average of 3 years

• Postoperative Morbidity Survey (POMS) on day 7 postoperatively

  Postoperative Morbidity Survey (POMS) on day 7 postoperatively

  From start of surgery to day 7 postoperatively

Secondary Outcomes (6)

• Difference in mitochondrial activity in platelets as measured by high resolution respirometry from start of surgery to day 7 postoperatively

  From start of surgery to day 7 post-operatively

• Difference in mitochondrial function as measured by 13C-KICA breath test from day before surgery to day 7 postoperatively

  From day before surgery to day 7 post-operatively

• Difference in mitochondrial activity in skeletal muscle as measured by high resolution respirometry from start of surgery to day 1 postoperatively

  From start of surgery to day 1 post-operatively

• Length of stay in ICU/HDU environment prior to ward step-down

  From start of surgery to day 7 post-operatively

• Duration of postoperative invasive mechanical ventilation

  From start of surgery to day 7 post-operatively

Interventions

Observational study: no interventions OTHER

Not applicable as observational study with no intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults having major elective abdominal surgery

You may qualify if:

• Aged 18 years or above.
• Having elective major abdominal surgery under general anaesthesia requiring a CVC and arterial line.
• Planned for a Total Intravenous Anaesthesia (TIVA) technique +/- additional regional or neuraxial anaesthesia.
• Admitted \>6 hours prior to planned start of surgery as part of their normal care

You may not qualify if:

• Currently pregnant or up to 6 weeks post-partum
• Participating in an interventional research study concerning intra-operative management already
• Lacks capacity to give consent to participate in the study at time of recruitment
• Currently in custody
• Surgery in the past 28 days
• Existing primary mitochondrial disease as defined by previous genetic testing/ genome- or exome- sequencing results, or formal diagnosis by a medical professional

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• University of Southampton: collaborator
• University of Cambridge: collaborator

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skeletal muscle, blood plasma/serum, red blood cells, exhaled breath

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: July 3, 2023
• Study Start: July 5, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

GB (1)