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

University of Pennsylvania

Status and phase: Completed; Early Phase 1

Conditions: Cardiovascular Shock; Circulatory Shock

Treatments: Drug: Nitroglycerin Topical Product

Study type: Observational

Funder types: Other

Identifiers

NCT05102734

843615

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

44 participants in 1 patient group

Topical nitroglycerin

Description:

A topical nitroglycerin solution will be applied to the area of interest

Treatment:

Drug: Nitroglycerin Topical Product