Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG

Helwan University

Status and phase: Enrolling; Phase 3

Conditions: Atrial Fibrillation

Treatments: Drug: Sodium Chloride 0.9% Inj; Drug: Calcium Chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06378021

Calcium chloride in CABG

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

4. 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Calcium chloride injection in ganglionated plexis for Atrial Fibrillation alleviation post CABG

Experimental group

Description:

The Patients in the intervention arm will be injected with Calcium chloride in the 4 major atrial ganglionated plexis after the by pass is completed.

Treatment:

Drug: Calcium Chloride

patients who will receive their regular standard of care without calcium chloride injection

Placebo Comparator group

Description:

A group of patients who will undergo Coronary artery bypass graft surgery will be injected with normal saline in the ganglionic Plexus during Coronary artery bypass graft to act as a comparator to determine if calcium chloride injection alleviate Atrial fibrillation post surgery

Treatment:

Drug: Sodium Chloride 0.9% Inj