Skip to main content
OpenTrials
Completed

NCT Number: NCT05102734

Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of the Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nitroglycerin Topical Product

Drug

Topical nitroglycerin solution

Primary outcomes

  1. Perfused Vessel Density (PVD)

    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.

    Estimate of functional capillary density.

Secondary outcomes

  1. Mean Arterial 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.

    Mean arterial blood pressure

  2. Cardiac Index

    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

    Cardiac output relative to patients body surface area

  3. Central Venous 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

    surrogate measure for right atrial pressure

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2021
Registry last updated
Apr 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.