POM-MP: PeriOp Metabolic & Mitochondrial Phenotype

Withdrawn

• Conditions: Surgical Complications From Bowel Surgery; Surgical Complications From Bladder Surgery; Surgical Complications From Surgery

• Registration Number: NCT04866199
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-27
• Study First Posted: 2021-04-29
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03
• Study Start: 2023-10
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mitochondrial oxygen consumption as measured by blood analysis	Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days)	The change between baseline and maximal oxygen consumption when maximum induced by additon of chemicals in vivo
Number of participants with post-operative complications as measured by Postoperative Morbidity Survey (POMS)	Up to 30 days post-op	Nine-domain tool used to assess the presence (or absence) of clinically significant changes using specified criteria. Confirmation of yes in any domain represents post-operative morbidity.
Change in the highest oxygen consumption (VO2 peak) as measured by wearable face mask	Baseline (preop) and Post-op (up to 30 days)	Measured in milliliters of oxygen per min
Change in MuscleSound %iMAT as measured by portable ultrasound	Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days)	The parameter is derived using a proprietary algorithm applied to the ultrasound image to estimate the amount of intramuscular adipose tissue, presented as percentage