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

NCT05102734 | Completed Results FDA Drug

• 1 other identifier: 843615
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Circulatory Shock; Cardiovascular Shock

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mean Arterial 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 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

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

Study Arms (1)

Topical nitroglycerin

A topical nitroglycerin solution will be applied to the area of interest

Drug: Nitroglycerin Topical Product

Interventions

Nitroglycerin Topical Product DRUG

Topical nitroglycerin solution

Topical nitroglycerin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective cardiovascular surgery

You may qualify if:

• 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

You may not qualify if:

• Surgical hemorrhage
• Unable to tolerate sublingual microcirculatory flow imaging
• Known intolerance or allergy to nitroglycerin
• Inadequate microcirculation imaging (based on Massey Score)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of the Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Shock; Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Necrosis

Results Point of Contact

• Title: Dr. John C. Greenwood
• Organization: Perelman School of Medicine at the University of Pennsylvania

john.greenwood@pennmedicine.upenn.edu

18568167172

Study Officials

• John C. Greenwood, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 1, 2021
• Study Start: September 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: March 1, 2022
• Last Updated: April 1, 2024
• Results First Posted: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (1)