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

Circulatory Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05102734
• Other study ID #: 843615
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Shock
• Circulatory Shock
• Shock
• Shock, Cardiogenic

Intervention

Drug:
• Nitroglycerin Topical Product
Topical nitroglycerin solution

Locations

Country	Name	City	State
United States	Hospital of the University of the Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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