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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcium chloride injection in ganglionated plexis for Atrial Fibrillation alleviation post CABG | Experimental | 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. |
|
| patients who will receive their regular standard of care without calcium chloride injection | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Chloride | Drug | 5 % calcium chloride injection in cardiac ganglionic Plexus during On pump Coronary artery bypass graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
1) Patients more than 18 years old 2 ) patients undergoing On pump CABG
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nadine O Elgarhi, pharmacist | Contact | 01144249948 | 02 | nadinesadek2013@hotmail.com |
| Ahmed A Foad, Assoc prof | Contact | 01114567874 | 02 |
| Name | Affiliation | Role |
|---|---|---|
| Abdelhameed I Ebid | Prof | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Recruiting | Cairo | Abassia Cairo | 02 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33413942 | Background | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D002122 | Calcium Chloride |
| D012965 | Sodium Chloride |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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|
| Sodium Chloride 0.9% Inj | Drug | 0.9% sodium chloride injection during on pump during Coronary artery bypass graft |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017606 |
| Chlorine Compounds |
| D017670 | Sodium Compounds |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |