Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201680255620 Date of Approval: 28/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of intraoperative low dose intravenous amiodarone in pharmacologic cardioversion in patients with preoperative atrial fibrillation presenting for mitral valve replacement surgery Randomized control trial
Official scientific title Efficacy of intraoperative low dose intravenous amiodarone in pharmacologic cardioversion in patients with preoperative atrial fibrillation presenting for mitral valve replacement surgery Randomized control trial
Brief summary describing the background and objectives of the trial Patients presented for mitral valve replacement and preoperative atrial fibrillation will recieve low dose of intravenous amiodarone and we will follow its efficacy to convert patients rhythm to sinus or not and we will compare it with control
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 07/01/2022
Actual trial start date 08/01/2022
Anticipated date of last follow up 07/04/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://journal.hsforum.com/index.php/HSF/article/view/4901
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Low dose amiodarone 1 mg/kg once Once will receive 1mg/kg amiodarone diluted in 50 ml dextrose 5% over 10 minutes shortly after induction of anesthesia. 45
Control Group Control Placebo dextrose 5% once Once patients will have the same volume of 50 ml of dextrose 5% over 10 minutes after induction of general anesthesia. 45 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
·       All elective isolated cases undergoing mitral valve replacement with a preoperative atrial fibrillation rhythm > 100/min as evidenced by ECG. ·       ASA physical status 2-5 ·       Sex (males and females) ·       Age 18-70 years. ·       Patients are refusing to participate in the study. ·       Below 18 or above 60 years. ·       Emergency and urgent patients. ·       Patients are undergoing combined valve or CABG surgery. ·       Patients with previous PCI. ·       Patients with rhythm defects evidenced by ECG. ·       Patient on amiodarone or other rhythm modifying drugs, e.g., Digoxin, Beta Blockers, CCBs, etc. ·       Patients with preoperative lung conditions or O2 saturation below 90%. ·       Patients with preoperative abnormal hepatic profiles identified by double average values of ALT/AST or bilirubin or hypoalbuminemia ·       Patients with preoperative renal impairment identified by serum creatinine more than 1.7 mg/dL ·       Abnormal thyroid profile or any history suggestive of thyroid diseases. ·       Diabetic patients, as the study, include Dextrose 5% based medication. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/01/2022 Ain shams university faculty of medicine research ethics committee FWA 000017585
Ethics Committee Address
Street address City Postal code Country
38 abbassyia square cairo cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Observe persistence of AF at the end of surgery and document rhythm before transfer to ICU. End of operation
Secondary Outcome Initial repercussion rhythm shortly after declamping will be recorded, whether ventricular fibrillation, normal sinus rhythm, or AF After declamping
Secondary Outcome §  Heart rate and rhythm 10, 30, 60 minutes after de-clamping. 60 minutes after declamping
Secondary Outcome §  Recurrence of AF during the hospital stay. Throughout hospital stays
Secondary Outcome Need for epicardial pacing. Throughout hospital stays
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cardiothoracic academy faculty of medicine ain shams university 392 ramses Street Abassyia cairo Egypt Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
self funded 137 mamdouh salem st nasr city cairo 11599 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor faculty of medicine ain shams unversity 38 abbassyia square cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammed Gamal 392 Ramses Street, Abbassya cairo 11355 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Mohammed Nabil mohammed_abdaljawad@med.asu.edu.eg +201111219461 392 Ramses Street, Abbassya
City Postal code Country Position/Affiliation
cairo 11355 Egypt assisstant professor cardiothothoracic surgery Ain Shams university
Role Name Email Phone Street address
Principal Investigator Mohammed Gamal mogamal19@gmail.com +201016844568 392 Ramses Street, Abbassya
City Postal code Country Position/Affiliation
cairo 11355 Egypt lectrurer of cardiothoracic surgery faculty of medicine ain shams university
Role Name Email Phone Street address
Public Enquiries Farouk Kamal dr.faroukkamal@med.asu.edu.eg +201066241179 137 mamdouh salem nasr city
City Postal code Country Position/Affiliation
cairo 11511 Egypt lecture of anesthesia faculty of medicine ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes I will give all IPD that underly the results of publication Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol one year controlled per request
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information