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This is an open-label, single center, trial that will enroll up to 25 participants with circulatory shock after cardiac surgery. Participants will be administered a topical sublingual nitroglycerin solution and assessed for changes microcirculatory blood flow using incident dark field microscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical nitroglycerin | A topical nitroglycerin solution will be applied to the area of interest |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitroglycerin Topical Product | Drug | Topical nitroglycerin solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perfused Vessel Density (PVD) | Estimate of functional capillary density. | Preoperative Control Group: assessed once preoperatively. For the topical nitroglycerin group, PVD measurements were obtained after surgery (baseline), then 3-minutes and 30-minutes after topical nitroglycerin administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure | Mean arterial blood pressure | MAP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes and 30-minutes after topical NTG application. |
| Cardiac Index |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective cardiovascular surgery
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| Name | Affiliation | Role |
|---|---|---|
| John C. Greenwood, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of the Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Publication of demographics, study drug effects, changes in hemodynamics and microcirculation. Limited, de-identified data can be made available upon request.
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20 patients were enrolled to obtain preoperative control microcirculation measurements only. 20 additional patients would be needed for the NTG challenge. NTG patients were enrolled prior to surgery, but not included if they did not meet postop inclusion criteria.
Patient recruitment completed between August 1 and October 30, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Topical Nitroglycerin | A topical nitroglycerin solution will be applied to the area of interest Nitroglycerin Topical Product: Topical nitroglycerin solution |
| FG001 | Preoperative Control Group | Subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topical Nitroglycerin | A topical nitroglycerin solution will be applied to the area of interest Nitroglycerin Topical Product: Topical nitroglycerin solution |
| BG001 | Preoperative Control Group |
| 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 Density (PVD) | Estimate of functional capillary density. | Sublingual microcirculation measurements were obtained in a preoperative control group to serve as a "healthy" control measurement to compare against measurements in patients with shock. The preoperative control group only had one PVD measurement taken. Sublingual microcirculation measurements in the topical nitroglycerin group were measured after surgery (baseline), then 3-minutes and 30-minutes after NTG solution application. | Posted | Mean | Standard Deviation | mm/mm^2 | Preoperative Control Group: assessed once preoperatively. For the topical nitroglycerin group, PVD measurements were obtained after surgery (baseline), then 3-minutes and 30-minutes after topical nitroglycerin administration. |
|
Preoperative Control Group: During pre-operative imaging Topical Nitroglycerin Group: At postoperative baseline imaging through 30-minutes after topical nitroglycerin application
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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 | Topical Nitroglycerin | A topical nitroglycerin solution will be applied to the area of interest Nitroglycerin Topical Product: Topical nitroglycerin solution |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John C. Greenwood | Perelman School of Medicine at the University of Pennsylvania | 18568167172 | 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, 2021 | Sep 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012769 | Shock |
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
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Cardiac output relative to patients body surface area
| Cardiac output was measured for the control group, then for the NTG group at postoperative baseline, 3-minuts, and 30-minutes after topical NTG application |
| Central Venous Pressure | surrogate measure for right atrial pressure | CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application |
| Inadequate video quality |
|
20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Topical Nitroglycerin Group Postop Baseline | Postop baseline measurement of PVD. A topical nitroglycerin solution will then be applied to the sublingual space. |
| OG002 | Topical Nitroglycerin Group 3-minutes Post-NTG | PVD response 3 minutes after topical NTG solution application. |
| OG003 | Topical Nitroglycerin Group 30-minutes Post-NTG | PVD measured 30 minutes after topical NTG solution application. |
|
|
| Secondary | Mean Arterial Pressure | Mean arterial blood pressure | Same groups as the primary outcome. | Posted | Mean | Standard Deviation | mmHg | MAP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes and 30-minutes after topical NTG application. |
|
|
|
| Secondary | Cardiac Index | Cardiac output relative to patients body surface area | Same groups as the primary outcome | Posted | Mean | Standard Deviation | L/min/m^2 | Cardiac output was measured for the control group, then for the NTG group at postoperative baseline, 3-minuts, and 30-minutes after topical NTG application |
|
|
|
| Secondary | Central Venous Pressure | surrogate measure for right atrial pressure | Same as the primary outcome | Posted | Mean | Standard Deviation | mmHg | CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application |
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|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Preoperative Control Group | 20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Post-NTG Challenge | PVD response after NTG challenge | 0 | 20 | 0 | 20 | 0 | 20 |
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| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D009336 | Necrosis |