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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR001879 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This study will examine the differences in microcirculatory function and mitochondrial respiration in patients with shock after cardiovascular surgery.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No shock | Patients who have no evidence of clinical malperfusion or require vasoactive agents after cardiac surgery. |
| |
| Shock | Patients who have evidence of clinical malperfusion or require vasoactive agents after cardiac surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| coronary artery bypass grafting, valve repair/replacement | Procedure | cardiovascular surgery with cardiopulmonary bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Patients with cardiovascular disease
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| Name | Affiliation | Role |
|---|---|---|
| John C. Greenwood | Perelman School of Medicine at the University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38578158 | Derived | Greenwood JC, Talebi FM, Jang DH, Spelde AE, Gordon EK, Horak J, Acker MA, Kilbaugh TJ, Shofer FS, Augoustides JGT, Brenner JS, Muzykantov VR, Bakker J, Abella BS. Anaerobic Lactate Production Is Associated With Decreased Microcirculatory Blood Flow and Decreased Mitochondrial Respiration Following Cardiovascular Surgery With Cardiopulmonary Bypass. Crit Care Med. 2024 Aug 1;52(8):1239-1250. doi: 10.1097/CCM.0000000000006289. Epub 2024 Apr 5. |
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The protocol for this trial will be published in a peer reviewed journal. The anonymized dataset supporting the results of this report will be available via the Zenodo research data repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | No Prolonged Organ Dysfunction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Perfused Vessel Denisty (PVD) | Perfused vessel density (PVD) was measured with incident darkfield microscopy (units mm/mm^2) | Patient met criteria for the primary outcome if they had 28 vasoactive and ventilator free days (VVFDs) or more at postoperative day 30. | Posted | Mean | Standard Deviation | mm/mm^2 | PVD was measured at baseline (immediately prior to surgery), at ICU admission, approximately 4 hours after surgery, then at 24 hours. |
|
Duration of in-hospital stay, an average of 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John C. Greenwood, MD, MS | University of Pennsylvania | 856-816-7172 | john.greenwood@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2020 | May 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012769 | Shock |
| D002318 | Cardiovascular Diseases |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| D012092 | Replantation |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Peripheral blood mononuclear cells, plasma
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | 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 |
|
|
| 3 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | 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 | 5 | 95 | 0 | 95 | 0 | 95 |
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| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D014180 | Transplantation |