Trial Outcomes & Findings for Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery (NCT NCT05330676)

NCT ID: NCT05330676

Last Updated: 2024-05-02

Results Overview

Perfused vessel density (PVD) was measured with incident darkfield microscopy (units mm/mm\^2)

• Recruitment status: COMPLETED
• Target enrollment: 142 participants
• Primary outcome timeframe: PVD was measured at baseline (immediately prior to surgery), at ICU admission, approximately 4 hours after surgery, then at 24 hours.
• Results posted on: 2024-05-02

Participant Flow

Participant milestones

Measure	Prolonged Organ Dysfunction Patients with 28 days or less of vasoactive and ventilator free days (VVFDs) at postoperative day 30 coronary artery bypass grafting, valve repair or replacement; cardiovascular surgery with cardiopulmonary bypass	No Prolonged Organ Dysfunction Patients with greater than 28 vasoactive and ventilator free days (VVFDs) at postoperative day 30. coronary artery bypass grafting, valve repair/replacement: cardiovascular surgery with cardiopulmonary bypass
Overall Study STARTED	38	104
Overall Study COMPLETED	36	95
Overall Study NOT COMPLETED	2	9

Reasons for withdrawal

Measure	Prolonged Organ Dysfunction Patients with 28 days or less of vasoactive and ventilator free days (VVFDs) at postoperative day 30 coronary artery bypass grafting, valve repair or replacement; cardiovascular surgery with cardiopulmonary bypass	No Prolonged Organ Dysfunction Patients with greater than 28 vasoactive and ventilator free days (VVFDs) at postoperative day 30. coronary artery bypass grafting, valve repair/replacement: cardiovascular surgery with cardiopulmonary bypass
Overall Study Inadequate imaging quality for final analysis	2	9

Baseline Characteristics

Evaluation of Microcirculatory Function and Mitochondrial Respiration After Cardiovascular Surgery

Baseline characteristics by cohort

Measure	Prolonged Organ Dysfunction n=36 Participants Patients with 28 days or less of vasoactive and ventilator free days (VVFDs) at postoperative day 30 coronary artery bypass grafting, valve repair or replacement; cardiovascular surgery with cardiopulmonary bypass	No Prolonged Organ Dysfunction n=95 Participants Patients with greater than 28 vasoactive and ventilator free days (VVFDs) at postoperative day 30. coronary artery bypass grafting, valve repair/replacement: cardiovascular surgery with cardiopulmonary bypass	Total n=131 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	37 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	58 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	31 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	64 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	87 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: PVD was measured at baseline (immediately prior to surgery), at ICU admission, approximately 4 hours after surgery, then at 24 hours.

Population: Patient met criteria for the primary outcome if they had 28 vasoactive and ventilator free days (VVFDs) or more at postoperative day 30.

Perfused vessel density (PVD) was measured with incident darkfield microscopy (units mm/mm^2)

Outcome measures

Measure	Prolonged Organ Dysfunction n=36 Participants Patients with 28 days or less of vasoactive and ventilator free days (VVFDs) at postoperative day 30 coronary artery bypass grafting, valve repair or replacement; cardiovascular surgery with cardiopulmonary bypass	No Prolonged Organ Dysfunction n=95 Participants Patients with greater than 28 vasoactive and ventilator free days (VVFDs) at postoperative day 30. coronary artery bypass grafting, valve repair/replacement: cardiovascular surgery with cardiopulmonary bypass
Perfused Vessel Denisty (PVD) ICU Admission	20.2 mm/mm^2 Standard Deviation 3.7	22.5 mm/mm^2 Standard Deviation 4.7
Perfused Vessel Denisty (PVD) 4-hours after surgery	21.1 mm/mm^2 Standard Deviation 3.9	22.8 mm/mm^2 Standard Deviation 4.9
Perfused Vessel Denisty (PVD) 24-hours	22.3 mm/mm^2 Standard Deviation 5.0	23.8 mm/mm^2 Standard Deviation 5.2
Perfused Vessel Denisty (PVD) Baseline	22.8 mm/mm^2 Standard Deviation 4.9	23.8 mm/mm^2 Standard Deviation 5.2

Adverse Events

Prolonged Organ Dysfunction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

No Prolonged Organ Dysfunction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

John C. Greenwood, MD, MS

University of Pennsylvania

Phone: 856-816-7172

Email: john.greenwood@pennmedicine.upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place