Atrial Fibrillation
Conditions
Keywords
Atrial fibrillation, Calcium chloride, On pump Coronary artery bypass graft
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.
Interventions
DRUGCalcium Chloride
5 % calcium chloride injection in cardiac ganglionic Plexus during On pump Coronary artery bypass graft
0.9% sodium chloride injection during on pump during Coronary artery bypass graft
Sponsors
Helwan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 74 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of patients who developed Atrial fibrillation | Up to one week from the time of surgery determined by serial ECGs per day | Compare if calcium chloride injection decrease the percentage of patients who developed Atrial fibrillation in intervention group with those in placebo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in length of hospital stay | Up to the time of patient discharge from the hospital (from the time of post Coronary artery bypass graft surgery) | investigate if calcium chloride will decrease duration of hospital stay compared with those in the placebo group who are injected with normal saline |
Countries
Egypt
Contacts
Primary ContactNadine O Elgarhi, pharmacist
Backup ContactAhmed A Foad, Assoc prof
Outcome results
None listed