Clinical trial NCT06378021: Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG
Official title: Post Operative Atrial Fibrillation: Alleviation by Calcium Chloride Injection Into Cardiac Ganglionic Plexus During Coronary Artery Bypass Grafting.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Calcium chloride
On pump Coronary artery bypass graft
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: This study hypothesize that injecting calcium chloride into the major atrial ganglionic plexus (GPs) during On pump Coronary artery bypass graft (CABG) can reduce the incidence of Post operative Atrial fibrillation by calcium-induced autonomic neurotoxicity, the incidence of Post operative Atrial fibrillation can be reduced by suppressing the function of the major atrial GPs and the surrounding neural network that play an important role in initiating Post operative Atrial fibrillation. The study is designed to be prospective interventional study two armed RCT for on pump CABG patient. The plan of work will include dividing the patients into 2 randomized control groups In the intervention group patients will be injected with 5% Calcium chloride in the 4 Major atrial ganglionic plexus The other arm will be Coronary artery bypass graft patients who will be injected with sodium chloride 0.9% to compare the two groups to evaluate to evaluate the effect of Calcium chloride in post CABG atrial fibrillation between the 2 arms of the study.

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.

Primary outcomes:
measure: Change in number of patients who developed Atrial fibrillation
timeFrame: Up to one week from the time of surgery determined by serial ECGs per day
Secondary outcomes:
measure: Change in length of hospital stay
timeFrame: Up to the time of patient discharge from the hospital (from the time of post Coronary artery bypass graft surgery)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
state: Abassia Cairo
Study officials:
affiliation: Prof
name: Abdelhameed I Ebid
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang H, Zhang Y, Xin F, Jiang H, Tao D, Jin Y, He Y, Wang Q, Po SS. Calcium-Induced Autonomic Denervation in Patients With Post-Operative Atrial Fibrillation. J Am Coll Cardiol. 2021 Jan 5;77(1):57-67. doi: 10.1016/j.jacc.2020.10.049.