Clinical trial NCT04866199: POM-MP: PeriOp Metabolic & Mitochondrial Phenotype
Official title: Peri-Operative Metabolic & Mitochondrial Phenotype Study: Prediction From Three Preoperative Assessments
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Surgical Complications From Surgery
Surgical Complications From Bladder Surgery
Surgical Complications From Bowel Surgery
Keywords: Surgery
Complication
Preoperative
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical patients identified in surgical clinic as candidates for bladder or bowel resection.

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.

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

Primary outcomes:
measure: Number of participants with post-operative complications as measured by Postoperative Morbidity Survey (POMS)
timeFrame: Up to 30 days post-op
measure: Change in the highest oxygen consumption (VO2 peak) as measured by wearable face mask
timeFrame: Baseline (preop) and Post-op (up to 30 days)
measure: Change in MuscleSound %iMAT as measured by portable ultrasound
timeFrame: Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days)
measure: Change in mitochondrial oxygen consumption as measured by blood analysis
timeFrame: Baseline (preop), postop Days 0, 1, 3 & 5, and Post-op (up to 30 days)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: David B MacLeod, FRCA
role: PRINCIPAL_INVESTIGATOR
References: