IRCT20180430039488N1
Recruiting
Phase 3
Evaluation of the efficacy of high dose corticosteroid regimen for treatment of postoperative high degree Atrioventricular block after valvular cardiac surgery ; A single blind randomized clinical trial
Tehran Heart Center0 sites150 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Advanced atrioventricular block following heart valve surgery.
- Sponsor
- Tehran Heart Center
- Enrollment
- 150
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Presence of advanced atrioventricular block following heart valve surgery including valve replacement or repair with or without CABG
- •Written documented informed consent
Exclusion Criteria
- •Exclusion of patients having cardiac pacemakers or intracardiac defibrilator\-cardiovertor or CRT
- •Exclusion of subjects having prior advanced AV block with underlying congenital or acquired etiologies or known brady\-arrhythmia
- •Exclusion of patients with acute or recent myocardial infarction or CPR during last week (or survivors of aborted sudden cardiac death)
- •Exclusion of diabetics with uncontrolled hyperglycemia ( BS\>200 in 2 or more measurements out of 4 samples during last 24 hours or HbA1C\>9, ketoacidosis or hyperglycemic hyperosmolar state)
- •Exclusion of patients with active infections
- •Exclusion of patients with immune deficiency disorders including malignancies and HIV\-AIDS,....
- •Exclusion of patients with prior history of hypersensitivity reactions to steroids
- •Exclusion of patients with persistent or permanent atrial fibrillation (AF for more than 24 hours except transient or paroxysmal cases)
Outcomes
Primary Outcomes
Not specified
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