Trial Outcomes & Findings for Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock. (NCT NCT05102734)

NCT ID: NCT05102734

Last Updated: 2024-04-01

Results Overview

Estimate of functional capillary density.

• Recruitment status: COMPLETED
• Target enrollment: 44 participants
• Primary outcome timeframe: 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.
• Results posted on: 2024-04-01

Participant Flow

Patient recruitment completed between August 1 and October 30, 2021.

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.

Participant milestones

Measure	Topical Nitroglycerin A topical nitroglycerin solution will be applied to the area of interest Nitroglycerin Topical Product: Topical nitroglycerin solution	Preoperative Control Group Subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.
Overall Study STARTED	24	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	4	0

Reasons for withdrawal

Measure	Topical Nitroglycerin A topical nitroglycerin solution will be applied to the area of interest Nitroglycerin Topical Product: Topical nitroglycerin solution	Preoperative Control Group Subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.
Overall Study Did not require vasopressors	1	0
Overall Study Did not have functioning PA catheter	1	0
Overall Study Inadequate video quality	2	0

Baseline Characteristics

Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.

Baseline characteristics by cohort

Measure	Topical Nitroglycerin n=20 Participants A topical nitroglycerin solution will be applied to the area of interest Nitroglycerin Topical Product: Topical nitroglycerin solution	Preoperative Control Group n=20 Participants 20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.	Total n=40 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	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 9 • n=5 Participants	67 years STANDARD_DEVIATION 11 • n=7 Participants	65 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	18 Participants n=5 Participants	20 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 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	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	18 Participants n=7 Participants	36 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: 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.

Population: 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.

Estimate of functional capillary density.

Outcome measures

Measure	Preoperative Control Group n=20 Participants 20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.	Topical Nitroglycerin Group Postop Baseline n=20 Participants Postop baseline measurement of PVD. A topical nitroglycerin solution will then be applied to the sublingual space.	Topical Nitroglycerin Group 3-minutes Post-NTG n=20 Participants PVD response 3 minutes after topical NTG solution application.	Topical Nitroglycerin Group 30-minutes Post-NTG n=20 Participants PVD measured 30 minutes after topical NTG solution application.
Perfused Vessel Density (PVD)	24.81 mm/mm^2 Standard Deviation 3.51	20.44 mm/mm^2 Standard Deviation 3.38	26.41 mm/mm^2 Standard Deviation 3.50	21.88 mm/mm^2 Standard Deviation 3.84

SECONDARY outcome

Timeframe: MAP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes and 30-minutes after topical NTG application.

Population: Same groups as the primary outcome.

Mean arterial blood pressure

Outcome measures

Measure	Preoperative Control Group n=20 Participants 20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.	Topical Nitroglycerin Group Postop Baseline n=20 Participants Postop baseline measurement of PVD. A topical nitroglycerin solution will then be applied to the sublingual space.	Topical Nitroglycerin Group 3-minutes Post-NTG n=20 Participants PVD response 3 minutes after topical NTG solution application.	Topical Nitroglycerin Group 30-minutes Post-NTG n=20 Participants PVD measured 30 minutes after topical NTG solution application.
Mean Arterial Pressure	95.85 mmHg Standard Deviation 11.67	71.05 mmHg Standard Deviation 5.92	70.35 mmHg Standard Deviation 6.8	74.4 mmHg Standard Deviation 7.19

SECONDARY outcome

Timeframe: 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

Population: Same groups as the primary outcome

Cardiac output relative to patients body surface area

Outcome measures

Measure	Preoperative Control Group n=20 Participants 20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.	Topical Nitroglycerin Group Postop Baseline n=20 Participants Postop baseline measurement of PVD. A topical nitroglycerin solution will then be applied to the sublingual space.	Topical Nitroglycerin Group 3-minutes Post-NTG n=20 Participants PVD response 3 minutes after topical NTG solution application.	Topical Nitroglycerin Group 30-minutes Post-NTG n=20 Participants PVD measured 30 minutes after topical NTG solution application.
Cardiac Index	2.54 L/min/m^2 Standard Deviation 0.79	2.85 L/min/m^2 Standard Deviation 0.81	2.88 L/min/m^2 Standard Deviation 0.9	2.83 L/min/m^2 Standard Deviation 0.76

SECONDARY outcome

Timeframe: CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application

Population: Same as the primary outcome

surrogate measure for right atrial pressure

Outcome measures

Measure	Preoperative Control Group n=20 Participants 20 subjects planned for elective cardiovascular surgery were enrolled to measure baseline microvascular function by sublingual incident darkfield microscopy imaging.	Topical Nitroglycerin Group Postop Baseline n=20 Participants Postop baseline measurement of PVD. A topical nitroglycerin solution will then be applied to the sublingual space.	Topical Nitroglycerin Group 3-minutes Post-NTG n=20 Participants PVD response 3 minutes after topical NTG solution application.	Topical Nitroglycerin Group 30-minutes Post-NTG n=20 Participants PVD measured 30 minutes after topical NTG solution application.
Central Venous Pressure	16.7 mmHg Standard Deviation 5.24	9.35 mmHg Standard Deviation 3.79	9.15 mmHg Standard Deviation 3.25	9.16 mmHg Standard Deviation 3.11

Adverse Events

Topical Nitroglycerin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Preoperative Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Post-NTG Challenge

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John C. Greenwood

Perelman School of Medicine at the University of Pennsylvania

Phone: 18568167172

Email: john.greenwood@pennmedicine.upenn.edu

Results disclosure agreements

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