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.: PACTR201801003026226 Date of Approval: 28/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Cardiac recovery after single, low esmolol dose in patients undergoing valve replacement surgery. A randomized controlled double-blind study
Official scientific title Cardiac recovery after single, low esmolol dose in patients undergoing valve replacement surgery. A randomized controlled double-blind study
Brief summary describing the background and objectives of the trial Background: Beta-blockers have a negative inotropic effect, so they better avoided in open heart surgery. Objectives: To evaluate the effect of low dose esmolol on cardiac recovery and rhythm in valve replacement surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,effect of esmolol on cardiac recovery during CPB surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2017
Actual trial start date 07/01/2017
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date 14/12/2017
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 70
Recruitment status Completed
Publication URL
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group esmolol 0.5 microgram/kg single injection iv 35
Control Group normal saline 0.5 microgram/kg single injection IV adminstration 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
includes all patients with rheumatic heart disease undergoing valve replacement therapy Patients with pericarditis were excluded 18 Year(s) 70 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 24/12/2017 anesthesia department,faculty of medicine,menoufiya university
Ethics Committee Address
Street address City Postal code Country
3, yassin abd elghafar street shibin elkoom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The recovery time (time from reperfusion to steady heart rate). time from reperfusion to steady heart rate
Secondary Outcome Ventricular fibrillation after primary re-beat time from reperfusion to steady heart rate
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menoufiya faculty of medicine hospital 3, yassin abd elghafar street shibin elkoom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufiya faculty of medicine 3, yassin abd elghafar street shibin elkoom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor menoufiya faculty of medicine 3, yassin abd elghafar street shibin elkoom Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ashraf Eskandr 3, yassin abd elghafar street shibin elkoom 12345 Egypt
khaled Gaballah 3, yassin abd elghafar street shibin elkoom 12345 Egypt
Asmaa Hamza 3, yassin abd elghafar street shibin elkoom 12345 Egypt
sadik abd-elmaseeh sadik 3, yassin abd elghafar street shibin elkoom 12345 Egypt
Mohammed El-Hag-Aly 3, yassin abd elghafar street shibin elkoom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ashraf eskandr ameskandr@yahoo.com 00201001960697 3, yassin abdelghafar
City Postal code Country Position/Affiliation
shibin elkoom 12334 Egypt associate professor of anesthesia, menoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries khaled gaballah ameskandr@yahoo.com 00201016009073 3, yassin abd elghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12334 Egypt lecturer of anesthesia,menoufiya university
Role Name Email Phone Street address
Scientific Enquiries asmaa hamza asmaa_6october@yahoo.com 00201004461611 3, yassin abd elghafar street
City Postal code Country Position/Affiliation
shibin elkoom 12334 Egypt lecturer of anesthesia,menoufiya university
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information