Role of Calcium Chloride Injection in Alleviating Atrial Fibrillation Post CABG

April 19, 2024 updated by: Nadine Osama Elgarhi, Helwan University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmed A Foad, Assoc prof
  • Phone Number: 02 01114567874

Study Locations

  • Egypt
    • Abassia Cairo
      • Cairo, Abassia Cairo, Egypt, 02
        • Recruiting
        • Ain Shams University
        • Contact:
          • Mohamed A Gamal, Ass prof
          • Phone Number: 02 010080827060
        • Principal Investigator:
          • Abdelhameed I Ebid, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium chloride injection in ganglionated plexis for Atrial Fibrillation alleviation post CABG
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
5 % calcium chloride injection in cardiac ganglionic Plexus during On pump Coronary artery bypass graft
Other Names:
  • 10% ampoules calcium chloride
Placebo Comparator: patients who will receive their regular standard of care without calcium chloride injection
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
0.9% sodium chloride injection during on pump during Coronary artery bypass graft
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in number of patients who developed Atrial fibrillation
Time Frame: 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
Up to one week from the time of surgery determined by serial ECGs per day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in length of hospital stay
Time Frame: 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
Up to the time of patient discharge from the hospital (from the time of post Coronary artery bypass graft surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helwan University

Investigators

  • Principal Investigator: Abdelhameed I Ebid, Prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

March 22, 2024

First Submitted That Met QC Criteria

April 19, 2024

First Posted (Actual)

April 22, 2024

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Calcium chloride in CABG

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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