Circulatory Shock Clinical Trial
Official title:
Trial of a Topical Nitroglycerin Challenge to Detect Reversible Microcirculatory Dysfunction in Patients With Circulatory Shock.
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 |
Verified date | March 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | Hospital of the University of the Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania |
United States,
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 |
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