Prophylaxis Against Postoperative Atrial Fibrillation in Patients Undergoing On-pump CABG

NCT03905759 | Unknown Phase 2

• 1 other identifier: FMBSURECS/31032019/Mohammed
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation in the postoperative period of myocardial revascularization surgery (AF-POMR) occurs in 10% to 65% of patients, increasing morbidity and mortality after surgery. is associated with an increase in hospital length of stay, and, thus, in costs,and can cause serious clinical complications, such as hypotension, heart failure, stroke and other thromboembolic disorders.Although not completely understood, the electrophysiological mechanism of AF-POMR is believed to be reentry.

Conditions

Postoperative Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• AF

  incidence of AF

  change from baseline rhythm at 6 days

Study Arms (3)

colchicine

ACTIVE COMPARATOR

Colchicine will be used at the dose of 1 mg orally, twice daily, preoperatively (1 days), and of 0.5 mg, twice daily, until hospital discharge

Drug: Colchicine

Dronedarone

ACTIVE COMPARATOR

Dronedarone (200 mg twice daily starting from day before operation till 5 days after)

Drug: Dronedarone

amiodarone

ACTIVE COMPARATOR

amiodarone (200 mg three times per day)21 administered 6 days prior to surgery through 6 days after surgery

Drug: Amiodarone

Interventions

Dronedarone DRUG

Dronedarone (200 mg twice daily starting from day before operation till 5 days after)

Also known as: amiodarone,colchicine

Dronedarone

Amiodarone DRUG

Group A:-amiodarone (200 mg three times per day)21 administered 6 days prior to surgery through 6 days after surgery

Also known as: colchicine ,dronedarone

amiodarone

Colchicine DRUG

Colchicine will be used at the dose of 1 mg orally, twice daily, preoperatively (1 days), and of 0.5 mg, twice daily, until hospital discharge

Also known as: amiodarone, dorendarone

colchicine

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The study population will include inpatients of the cardiothoracic department scheduled for CABG surgery, both sex, selected randomly according to American Society of Anesthesiologists(ASA) grade II and III

You may not qualify if:

• \- Liver dysfunction, pregnancy.
• History of allergic reaction to any drug used in this study.
• Emergency procedure
• Preoperative dialysis
• A.F.
• Patients on antiarrhythmic medications

Sponsors & Collaborators

• doaa rashwan: lead

Study Sites (1)

Faculty Of Medicine, Beni-Suef University

Banī Suwayf, 11391, Egypt

RECRUITING

MeSH Terms

Interventions

Dronedarone; Amiodarone; Colchicine

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Alkaloids

Study Officials

• belal Y Mohammed, Msc

  Faculty of Medicine Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doaa A Rashwan, MD

CONTACT

00201011270763; doaa_rashwan@hotmail.com

Belal Y Mohammed, Msc

CONTACT

0020124138153; byahia37@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant profesor Doaa Rashwan

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 5, 2019
• Study Start: April 3, 2019
• Primary Completion: April 10, 2020
• Study Completion: April 10, 2020
• Last Updated: April 5, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: after registration for ever
• Access Criteria: on the web page

Locations

EG (1)