Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06378021
• Other study ID #: Calcium chloride in CABG
• Status: Recruiting
• Phase: Phase 3
• Start date: March 14, 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Helwan University
• Contact: Nadine O Elgarhi, pharmacist
• Phone: 01144249948
• Email: nadinesadek2013[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Calcium Chloride
5 % calcium chloride injection in cardiac ganglionic Plexus during On pump Coronary artery bypass graft
• Sodium Chloride 0.9% Inj
0.9% sodium chloride injection during on pump during Coronary artery bypass graft

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo	Abassia Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Helwan University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in number of patients who developed Atrial fibrillation	Compare if calcium chloride injection decrease the percentage of patients who developed Atrial fibrillation in intervention group with those in placebo group	Up to one week from the time of surgery determined by serial ECGs per day
Secondary	Change in length of hospital stay	investigate if calcium chloride will decrease duration of hospital stay compared with those in the placebo group who are injected with normal saline	Up to the time of patient discharge from the hospital (from the time of post Coronary artery bypass graft surgery)