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

Trial of a Topical Nitroglycerin Challenge to Detect Reversible Microcirculatory Dysfunction in Patients With Circulatory Shock.

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 Overview

• Status: Completed
• Conditions: Cardiovascular Shock; Circulatory Shock
• Intervention / Treatment: Drug: Nitroglycerin Topical Product

• Study Type: Observational
• Enrollment (Actual): 44

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of the Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective cardiovascular surgery

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Topical nitroglycerin; A topical nitroglycerin solution will be applied to the area of interest	Drug: Nitroglycerin Topical Product; Topical nitroglycerin solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfused Vessel Density (PVD)	Estimate of functional capillary density.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure	Mean arterial blood 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 relative to patients body surface area	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	CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: John C. Greenwood, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: October 21, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Shock; Shock, Cardiogenic; Vasodilator Agents; Nitroglycerin
• Other Study ID Numbers: 843615

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication of demographics, study drug effects, changes in hemodynamics and microcirculation. Limited, de-identified data can be made available upon request.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No