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

Completed

• Conditions: Circulatory Shock; Cardiovascular Shock
• Interventions: Drug: Nitroglycerin Topical Product

• Registration Number: NCT05102734
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Study First Posted: 2021-11-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-03-01
• Results First Submitted: 2022-10-31
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-29
• Last Update Submitted: 2024-03-29
• Results First Posted: 2024-04-01
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Adult patients receiving elective CABG or valvular surgery requiring cardiopulmonary bypass
• Receiving postoperative catecholamine therapy to maintain a MAP > 65mmHg, cardiac index > 2 despite initial fluid resuscitation
• Invasive hemodynamic monitoring

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Exclusion Criteria

• Surgical hemorrhage
• Unable to tolerate sublingual microcirculatory flow imaging
• Known intolerance or allergy to nitroglycerin
• Inadequate microcirculation imaging (based on Massey Score)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Topical nitroglycerin	Nitroglycerin Topical Product	A topical nitroglycerin solution will be applied to the area of interest

Primary Outcome Measures

Name	Time	Method
Perfused Vessel Density (PVD)	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.	Estimate of functional capillary density.

Secondary Outcome Measures

Name	Time	Method
Mean Arterial 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.	Mean arterial blood pressure
Cardiac Index	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	Cardiac output relative to patients body surface area
Central Venous 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	surrogate measure for right atrial pressure

Trial Locations

Locations (1)

Hospital of the University of the Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States