Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05102734
Other study ID # 843615
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04357275 - The RIsk Stratification in COVID-19 Patients in the ICU Registry
Withdrawn NCT03483753 - Vasopressin or Norepinephrine in Vasoplegic Shock After Non-cardiac Surgery Phase 2/Phase 3
Active, not recruiting NCT06376318 - Shock and Acute Conditions OutcOmes Platform
Recruiting NCT06265259 - Efficacy of the Use of Vasopressin as a Primary Vasoconstrictor in Critically Ill Patients Phase 4