NCT05102734CompletedNot Applicable
Trial of a Topical Nitroglycerin Challenge to Detect Reversible Microcirculatory Dysfunction in Patients With Circulatory Shock.
University of Pennsylvania1 site in 1 country44 target enrollmentStarted: September 1, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Perfused Vessel Density (PVD)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Topical nitroglycerin
A topical nitroglycerin solution will be applied to the area of interest
Intervention: Nitroglycerin Topical Product (Drug)
Outcomes
Primary Outcomes
Perfused Vessel Density (PVD)
Time Frame: 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 Outcomes
- 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.)
- 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)
- 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)
Investigators
Study Sites (1)
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