MicroRESUS: Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery

Sponsor

University of Pennsylvania (Other)

Overall Status

Recruiting

CT.gov ID

NCT05330676

Collaborator

National Center for Advancing Translational Science (NCATS) (NIH)

140

Enrollment

Location

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine the differences in microcirculatory function and mitochondrial respiration in patients with shock after cardiovascular surgery.

Condition or Disease	Intervention/Treatment	Phase
Shock Cardiovascular Diseases Critical Illness	Procedure: coronary artery bypass grafting, valve repair/replacement

Detailed Description

Post-cardiotomy shock (PCS) occurs in up to 5% of cardiovascular surgeries and has an in-hospital mortality rate as high as 75%. It is unclear if patients with PCS despite achieving standard resuscitation goals have impairments in oxygen delivery or oxygen utilization. This study will examine the difference in microcirculatory function and mitochondrial respiration in patients with shock to better understand the driving mechanism of bioenergetic failure in patients with PCS.

Study Design

Study Type:

Observational

Anticipated Enrollment :

140 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The MicroRESUS Study: An Observational Study to Examine the Effects of Circulatory Shock and Resuscitation on Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery.

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No shock Patients who have no evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.	Procedure: coronary artery bypass grafting, valve repair/replacement cardiovascular surgery with cardiopulmonary bypass
Shock Patients who have evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.	Procedure: coronary artery bypass grafting, valve repair/replacement cardiovascular surgery with cardiopulmonary bypass

Arm

Intervention/Treatment

No shock

Patients who have no evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.

Procedure: coronary artery bypass grafting, valve repair/replacement

cardiovascular surgery with cardiopulmonary bypass

Shock

Patients who have evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.

Procedure: coronary artery bypass grafting, valve repair/replacement

cardiovascular surgery with cardiopulmonary bypass

Outcome Measures

Primary Outcome Measures

vasopressor and ventilator free days [30 days]
Number of days patients are free of invasive or non-invasive mechanical ventilation or vasoactive medications.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria: Adult patients (>18 years old) receiving elective coronary artery bypass graft (CABG) or valvular surgery requiring cardiopulmonary bypass are eligible for enrollment.

Exclusion Criteria: Patients will be excluded if they are unable to tolerate sublingual microcirculatory flow imaging (e.g., non-intubated patients dependent upon oxygen by facemask, poor mouth opening), receiving an emergent procedure, have an actively treated malignancy, mitochondrial disorder, or are receiving surgery requiring deep hypothermic circulatory arrest.