Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery

Completed

• Conditions: Shock; Cardiovascular Diseases; Critical Illness
• Interventions: Procedure: coronary artery bypass grafting, valve repair/replacement

• Registration Number: NCT05330676
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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 Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2022-04-09
• Study First Submitted QC: 2022-04-09
• Study First Posted: 2022-04-15
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01
• Results First Submitted: 2024-03-25
• Status Verified: 2024-05
• Results First Submitted QC: 2024-05-01
• Last Update Submitted: 2024-05-01
• Results First Posted: 2024-05-02
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No shock	coronary artery bypass grafting, valve repair/replacement	Patients who have no evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.
Shock	coronary artery bypass grafting, valve repair/replacement	Patients who have evidence of clinical malperfusion or require vasoactive agents after cardiac surgery.

Primary Outcome Measures

Name	Time	Method
Perfused Vessel Denisty (PVD)	PVD was measured at baseline (immediately prior to surgery), at ICU admission, approximately 4 hours after surgery, then at 24 hours.	Perfused vessel density (PVD) was measured with incident darkfield microscopy (units mm/mm\^2)

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States