POM-MP: PeriOp Metabolic & Mitochondrial Phenotype

NCT ID: NCT04866199

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-31
• Study Completion Date: 2024-08-31

Brief Summary

Patients scheduled for bladder or bowel resection will receive assessments at three time points:

1. Preoperatively up to 30 days prior to scheduled surgery

2. Postoperatively in hospital up to 5 days

3. Postoperatively up to 30 days following scheduled surgery

At all time points the subjects will have blood samples drawn for mitochonrial function analysis and a muscle ultrasound (MuscleSound) performed. In addition, a cardiopulmonary exercise test (CPET or 'VO2 max') will be performed at the 30 day pre/post evaluation time points.

Detailed Description

Cardiorespiratory fitness (CRF) is a measure of the efficiency to use oxygen. One method used to measure CRF is the cardiopulmonary exercise test (CPET), otherwise known as 'VO2 max'. Previous studies have shown that individuals assessed with CPET-derived parameters, such as VO2 max or anaerobic threshold (AT), below specific thresholds are at greater risk of post-operative complications, which can occur in up to 40% of surgical patients.

This study wants to determine if other methods of fitness or well-being, such as mitochondrial oxygen consumption and muscle ultrasound to determine muscle characteristics, can be combined with CPET assessment to improve the ability to identify surgical patients who develop postoperative complications, as measured by the validated tool, POMS.

The objective of the study is to create a method to identify the metabolic and mitochondrial phenotype of the perioperative patient, termed the POM-MP.

Conditions

Surgical Complications From Surgery; Surgical Complications From Bladder Surgery; Surgical Complications From Bowel Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

High-risk colon or bladder surgical patients

Patients who are diagnosed with colon or bladder cancer requiring surgical resection.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adults aged >18 undergoing bladder or bowel resection
• Able to speak English
• Ambulatory (assistive devices OK)
• Able to consent
• Willing to perform Cardiopulmonary Exercise Testing

Exclusion Criteria

• Unable to perform CPET
• Pregnant
• Prisoner
• Patients with diagnosed Dementia
• Unable to ambulate independently

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David B MacLeod, FRCA

Role: PRINCIPAL_INVESTIGATOR

Duke University

Other Identifiers

Pro00108362

Identifier Type: -

Identifier Source: org_study_id