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NCT05330676 Clinical Trial

Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery

Cardiovascular Diseases Clinical Trial

— MicroRESUS  

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05330676
Other study ID # 843614
Secondary ID KL2TR001879
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date April 1, 2023

Study information
Verified date May 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 142
Est. completion date April 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Adult patients (>18 years old) - Receiving elective coronary artery bypass graft (CABG) - Receiving valvular surgery requiring cardiopulmonary bypass Exclusion Criteria: - 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 - receiving surgery requiring deep hypothermic circulatory arrest.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• coronary artery bypass grafting, valve repair/replacement
cardiovascular surgery with cardiopulmonary bypass

Locations
Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
University of Pennsylvania National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Perfused Vessel Denisty (PVD) Perfused vessel density (PVD) was measured with incident darkfield microscopy (units mm/mm^2) PVD was measured at baseline (immediately prior to surgery), at ICU admission, approximately 4 hours after surgery, then at 24 hours.
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