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

NCT ID: NCT05102734

Last Updated: 2024-04-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Circulatory Shock Cardiovascular Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Topical nitroglycerin

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

Nitroglycerin Topical Product

Intervention Type DRUG

Topical nitroglycerin solution

Interventions

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Nitroglycerin Topical Product

Topical nitroglycerin solution

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John C. Greenwood, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Hospital of the University of the Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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843615

Identifier Type: -

Identifier Source: org_study_id

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