Circulatory ShockNCT05102734
Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.
An observational study of Circulatory Shock and Cardiovascular Shock, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Circulatory Shock, Cardiovascular Shock
- What is being tested?
- Nitroglycerin Topical Product
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 1 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective cardiovascular surgery
Who may be able to join
- 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
Who cannot join
- Surgical hemorrhage
- Unable to tolerate sublingual microcirculatory flow imaging
- Known intolerance or allergy to nitroglycerin
- Inadequate microcirculation imaging (based on Massey Score)
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of the Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Trial of a Topical Nitroglycerin Challenge to Detect Reversible Microcirculatory Dysfunction 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.
- Conditions
- Circulatory Shock, Cardiovascular Shock
- Being tested
- Nitroglycerin Topical Product
- Medical subject headings
- Shock, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitroglycerin Topical ProductDrug
Topical nitroglycerin solution
| Study group | Role | What they receive |
|---|---|---|
| Topical nitroglycerin | A topical nitroglycerin solution will be applied to the area of interest Receives: Drug: Nitroglycerin Topical Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfused Vessel Density (PVD)
Estimate of functional capillary density.
Measured: 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 outcomes (3)
Mean Arterial Pressure
Mean arterial blood pressure
Measured: MAP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes and 30-minutes after topical NTG application.
Cardiac Index
Cardiac output relative to patients body surface area
Measured: 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
Central Venous Pressure
surrogate measure for right atrial pressure
Measured: CVP was recorded for the control group, then for the NTG group at postoperative baseline, 3-minutes, and 30-minutes after topical NTG application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Sep 2021
- Primary completion1 Feb 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Circulatory ShockStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John C. Greenwood, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102734
- Sponsor's protocol ID
- 843615
- Status last verified
- Mar 2024
- First submitted
- 21 Oct 2021
- Last updated
- 1 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of demographics, study drug effects, changes in hemodynamics and microcirculation. Limited, de-identified data can be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of a Topical Nitroglycerin Challenge to Detect Reversible Microcirculatory Dysfunction in Patients With Circulatory Shock.
- ClinicalTrials.gov ID
- NCT05102734
- Acronym / sponsor ID
- 843615
- Conditions
- Circulatory Shock, Cardiovascular Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Posted 1 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical nitroglycerin | – | Drug: Nitroglycerin Topical ProductA topical nitroglycerin solution will be applied to the area of interest |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective cardiovascular surgery
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Surgical hemorrhage
- Unable to tolerate sublingual microcirculatory flow imaging
- Known intolerance or allergy to nitroglycerin
- Inadequate microcirculation imaging (based on Massey Score)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitroglycerin Topical ProductTopical nitroglycerin solution | Drug | Topical nitroglycerin |
Primary outcome
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.
3 secondary outcomes
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.
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Publication of demographics, study drug effects, changes in hemodynamics and microcirculation. Limited, de-identified data can be made available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John C. Greenwood, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory Shock and Cardiovascular Shock, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.