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N/A N=44

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

Circulatory Shock · Cardiovascular Shock

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

OutcomeResultp-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)
View full record on ClinicalTrials.gov →

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.

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