N/A
N=44
Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.
Circulatory Shock · Cardiovascular Shock
Bottom Line
View on ClinicalTrials.gov: NCT05102734 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Perfused Vessel Density (PVD) — 24.81; 20.44; 26.41; 21.88 mm/mm^2
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Nitroglycerin Topical Product (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perfused Vessel Density (PVD) |
24.81; 20.44; 26.41; 21.88 | — |
| SECONDARY Mean Arterial Pressure |
95.85; 71.05; 70.35; 74.4 | — |
| SECONDARY Cardiac Index |
2.54; 2.85; 2.88; 2.83 | — |
| SECONDARY Central Venous Pressure |
16.7; 9.35; 9.15; 9.16 | — |
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.
Eligibility 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
- Inadequate microcirculation imaging (based on Massey Score)
Data sourced from ClinicalTrials.gov (NCT05102734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.