Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock: a Phase 0 Trial.

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is an open-label, single center, Phase 0 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Nitroglycerin

Criteria

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