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.: PACTR201802002998973 Date of Approval: 21/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Milrinone in status asthmaticus
Official scientific title The use of Milrinone versus conventional treatment for the management of life-threatening bronchial asthma
Brief summary describing the background and objectives of the trial most asthma can be controlled with medication an estimated 5-10% of the USA asthma and world population is considered to have the most severe persistent form of the disease that does not respond well to treatment. These people are likely to have more attacks and are more at risk of a fatal attack.In the past 25 years literature has hinted at the therapeutic potential of phosphodiesterase inhibitors in asthma. The purpose of this study is to assess the effectiveness of using milrinone as a rescue drug in life-threatening bronchial asthma
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied bronchial asthma,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/10/2017
Actual trial start date 11/11/2017
Anticipated date of last follow up 03/03/2018
Actual Last follow-up date 18/01/2018
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
nil known FWA000017585
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 Open-label(Masking Not Used) Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group milrinone 25 ¿g milrinone as an initial slow IV bolus diluted in 10 ml of normal saline. Within 10 minutes if this dose did not provide effective relief it was followed by another slow IV bolus dose of 25 ¿g mi bouls rescuer drug in treatment of status asthmaticus 25 Active-Treatment of Control Group
Control Group control group 10 ml saline without medication as aplacebo then another 10 ml after 10 minute 1 hour will be received conventional treatment for life-threatening asthma according to the latest British Guideline on the management of asthma 2008, revised October 2014.[5] Treatment consisted of: ¿ Supplementary O2 to all hypoxemic patients (SpO2 < 92%) to maintain SpO2 level 94-98%. ¿ High dose inhaled ¿2 agonist or nebulized ¿2 agonist (salbutamol). ¿ Nebulized ipratropium bromide (0.5 mg every 20 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients ranging age 18-50 years old arriving at the emergency room with life-threatening asthma according to the criteria of the British Guideline on the management of asthma 2008, revised October 2014. Life-threatening asthma is defined as any one or more of the following criteria: ¿ PEF <33% best or predicted ¿ SpO2 <92% ¿ PaO2 <8 kPa (60 mm Hg) ¿ Normal PaCO2 (4.6-6.0 kPa) (35-45 mm Hg) ¿ Silent chest ¿ Cyanosis ¿ Poor respiratory effort ¿ Arrhythmia ¿ Exhaustion, altered conscious level ¿ Hypotension ¿ patientes with pre-existing heart failure, hypotensive patients, stenotic or obstructive valvular disease or other outlet obstruction, and patients with pre-existing arrhythmia 18 Year(s) 50 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 01/11/2017 FMASU REC
Ethics Committee Address
Street address City Postal code Country
faculty of medicine -ain shams- university-abassia cairo 11539 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assess the effectiveness of using milrinone as a rescue drug in life-threatening bronchial asthma PaO2 1 after hour PaCO2 after 1 hour PEF expressed as % of the patients previous best value, measured by peak flowmeter.will be assessed at 10 min after and after 1 hour
Secondary Outcome reducing the number of patients requiring mechanical ventilation. after 1 hour
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ain shames university hospitals 56 Ramsis St., Abbasseya, Cairo Behind El Nour Mosque cairo 11539 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
myself my adress cairo 11511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor dramrsobhy 13 el makwleen elarab-heiolioplis cairo 11511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
hany zaki victor naser city cairo 117645 Egypt
doaa mohammed kamal ain shame
ahmed nabil hamdy nasr city cairo 117645 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator amr sobhy dr.amrsobhy2013@gmail.com 002001063394383 heiliuopilos
City Postal code Country Position/Affiliation
cairo 11511 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries sahar kandil saharkandil262@gmail.com 20201224898998 ramsis street,abassia square department of community and occupational medicine
City Postal code Country Position/Affiliation
cairo 11591 Egypt associate profossor
Role Name Email Phone Street address
Scientific Enquiries amr sobhy dr.amrsobhy2013@gmail.com 20201063394383 ramsis st ,abbassia square,department of anasthesia, Intensive care and pain mangament-ain shams university
City Postal code Country Position/Affiliation
cairo 11591 Egypt lecturer at faculty of medicine -ain shames university
REPORTING
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