Cardiovascular Diseases, Critical Illness, Shock
Conditions
Keywords
microcirculation, mitochondrial respiration, circulatory shock, cardiovascular surgery, resuscitation
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.
Interventions
PROCEDUREcoronary artery bypass grafting, valve repair/replacement
cardiovascular surgery with cardiopulmonary bypass
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 36 |
| 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 | 95 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inadequate imaging quality for final analysis | 2 | 9 |
Baseline characteristics
| Characteristic | Prolonged Organ Dysfunction | No Prolonged Organ Dysfunction | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 58 Participants | 79 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 37 Participants | 52 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 87 Participants | 117 Participants |
| Sex: Female, Male Female | 11 Participants | 31 Participants | 42 Participants |
| Sex: Female, Male Male | 25 Participants | 64 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 36 | 5 / 95 |
| other Total, other adverse events | 0 / 36 | 0 / 95 |
| serious Total, serious adverse events | 0 / 36 | 0 / 95 |
Outcome results
Primary
Perfused Vessel Denisty (PVD)
Perfused vessel density (PVD) was measured with incident darkfield microscopy (units mm/mm\^2)
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Prolonged Organ Dysfunction | Perfused Vessel Denisty (PVD) | Baseline | 22.8 mm/mm^2 | Standard Deviation 4.9 |
| Prolonged Organ Dysfunction | Perfused Vessel Denisty (PVD) | ICU Admission | 20.2 mm/mm^2 | Standard Deviation 3.7 |
| Prolonged Organ Dysfunction | Perfused Vessel Denisty (PVD) | 4-hours after surgery | 21.1 mm/mm^2 | Standard Deviation 3.9 |
| Prolonged Organ Dysfunction | Perfused Vessel Denisty (PVD) | 24-hours | 22.3 mm/mm^2 | Standard Deviation 5 |
| No Prolonged Organ Dysfunction | Perfused Vessel Denisty (PVD) | 24-hours | 23.8 mm/mm^2 | Standard Deviation 5.2 |
| No Prolonged Organ Dysfunction | Perfused Vessel Denisty (PVD) | Baseline | 23.8 mm/mm^2 | Standard Deviation 5.2 |
| No Prolonged Organ Dysfunction | Perfused Vessel Denisty (PVD) | 4-hours after surgery | 22.8 mm/mm^2 | Standard Deviation 4.9 |
| No Prolonged Organ Dysfunction | Perfused Vessel Denisty (PVD) | ICU Admission | 22.5 mm/mm^2 | Standard Deviation 4.7 |