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

University of Pennsylvania44 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Circulatory Shock Cardiovascular Shock

Interventions

Nitroglycerin Topical ProductDRUG

Topical nitroglycerin solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)

Locations (1)

Hospital of the University of the Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Perfused Vessel Density (PVD)

Estimate of functional capillary density.

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.

Secondary Outcomes

Mean Arterial Pressure

Mean arterial blood pressure

Time frame: 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 relative to patients body surface area

Time frame: 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

surrogate measure for right atrial pressure

Time frame: CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application

Data from ClinicalTrials.gov

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