Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG

NCT06378021 | Recruiting Phase 3 DMC

• 1 other identifier: Calcium chloride in CABG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Calcium chloride; On pump Coronary artery bypass graft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (2)

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.

Drug: Calcium Chloride

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

Drug: Sodium Chloride 0.9% Inj

Interventions

Calcium Chloride DRUG

5 % calcium chloride injection in cardiac ganglionic Plexus during On pump Coronary artery bypass graft

Also known as: 10% ampoules calcium chloride

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

Sodium Chloride 0.9% Inj DRUG

0.9% sodium chloride injection during on pump during Coronary artery bypass graft

Also known as: Normal saline

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

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients more than 18 years old 2 ) patients undergoing On pump CABG

You may not qualify if:

• patients \>75 years of age
• Patients with Pre operative Atrial fibrillation
• Patients with Significant valvular disease
• \. 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Ain shams university

Cairo, Abassia Cairo, 02, Egypt

RECRUITING

Related 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.

  PMID: 33413942 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Calcium Chloride; Sodium Chloride; Saline Solution

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Calcium Compounds; Inorganic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Abdelhameed I Ebid

  Prof

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine O Elgarhi, pharmacist

CONTACT

01144249948; nadinesadek2013@hotmail.com

Ahmed A Foad, Assoc prof

CONTACT

01114567874

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of pharmacy

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 22, 2024
• Study Start: March 14, 2024
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

EG (1)