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Clinical trial

Post Operative Atrial Fibrillation: Alleviation by Calcium Chloride Injection Into Cardiac Ganglionic Plexus During Coronary Artery Bypass Grafting.

ID
Name
Calcium chloride in CABG
Description
This study hypothesize that injecting calcium chloride (CaCl2) into the major atrial ganglionated plexus (GPs) during on pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation in the first 7 days after surgery.The study is designed to be prospective interventional study two armed RCT for on pump CABG patient. The intervention arm will be injected with Calcium chloride in the four major atrial ganglionic plexus The control arm will be injected with sodium chloride to determine the effect of Calcium chloride on Post CABG Atrial fibrillation
Trial arms
Trial start
2024-03-14
Estimated PCD
2025-03-01
Trial end
2025-04-01
Status
Recruiting
Phase
Early phase I
Treatment
Calcium Chloride
5 % calcium chloride injection in cardiac ganglionic Plexus during On pump Coronary artery bypass graft
Arms:
Calcium chloride injection in ganglionated plexis for Atrial Fibrillation alleviation post CABG
Other names:
10% ampoules calcium chloride
Sodium Chloride 0.9% Inj
0.9% sodium chloride injection during on pump during Coronary artery bypass graft
Arms:
patients who will receive their regular standard of care without calcium chloride injection
Other names:
Normal saline
Size
100
Primary endpoint
Change in number of patients who developed Atrial fibrillation
Up to one week from the time of surgery determined by serial ECGs per day
Eligibility criteria
Inclusion Criteria: 1) Patients more than 18 years old 2 ) patients undergoing On pump CABG Exclusion Criteria: 1. patients \>75 years of age 2. Patients with Pre operative Atrial fibrillation 3. Patients with Significant valvular disease 5. Ejection fraction \<30% 6. Combined surgery of any kind 7. Congenital heart disease 8. Abnormal severe liver or kidney dysfunction. 9. Patients undergoing Off-pump CABG 10. Poorly controlled hyperthyroidism 11. Refusal to enrollment.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2024-04-22

1 organization

2 products

1 indication

Organization
Helwan University
Product
Calcium Chloride
Indication
Atrial Fibrillation
Product
Sodium Chloride 0.9% Inj