CompletedNot Applicable

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

United States44 participantsStarted 2021-09-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Perfused Vessel Density (PVD)

Timeframe: 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.

Trial details

NCT IDNCT05102734

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-02-01

Results submitted2022-10-31

View on ClinicalTrials.gov More Circulatory Shock trials