Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia (NCT06355882) | Clinical Trial Compass
UnknownNot Applicable
Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia
Brazil29 participantsStarted 2023-08-08
Plain-language summary
Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with advanced heart failure, in INTERMACS III using dobutamine at 5 to 20 µg/kg/minute due to low cardiac output syndrome
* Presence of periodontal disease, in the 4th or 6th sextant with indication of supragingival and/or subgingival periodontal scaling;
* Residual root or teeth with periodontal disease in the jaw, with simple extraction indicated.
Exclusion Criteria:
* Patients with a ventricular assist device such as an intra-aortic balloon implanted less than 24 hours after the dental procedure or with extracorporeal membrane oxygenation (ECMO);
* Using other inotropes;
* On mechanical ventilation;
* Continuously using a non-invasive ventilation mask;
* In septic shock;
* Presence of acute myocardial infarction \<30 days;
* Patients with terminal non-cardiac disease, cyanotic congenital heart disease or cardiomyopathies with arrhythmogenic potential (arrhythmogenic dysplasia, hypertrophic cardiomyopathy, non-compacted myocardium);
* Pregnant women;
* History of sudden death recovered \< 1 month ago;
* In the recent postoperative period of cardiac surgery (5 days);
* Allergic to sodium bisulfite and methylparaben, preservatives of epinephrine and the anesthetic cartridge, respectively.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Amount ventricular and supraventricular arrhythmia