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.: PACTR201909691980023 Date of Approval: 25/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Hypertonic Saline 3% Nebulizer versus intravenous hypertonic saline 3% in ARDS
Official scientific title Evaluation of the Use of Hypertonic Saline 3% Nebulizer versus intravenous hypertonic saline 3% to attenuate the Manifestations of Acute Respiratory Distress Syndrome
Brief summary describing the background and objectives of the trial Acute respiratory distress syndrome (ARDS) is well known disease represents big challenge to medical staff with unfortunately high mortality rates at the end, Initiation of hypertonic saline nebulization therapy for patients with early ARDS appears to be tolerable and may be beneficial with significant improving in oxygenation with trend to decrease mortality, ICU stay, and mechanical ventilation days and so may be added to protective lung strategy But using nebulizer is cumbersome and there are chances of carrying the infection from unsterile chambers or tubing's into the lungs, especially with long term use and a lot of drug is wasted The purpose of this study is to assess the effectiveness of using Hypertonic Saline 3% nebulizer versus intravenous to attenuate the Manifestations of ARDS
Type of trial RCT
Acronym (If the trial has an acronym then please provide) hyper tonic saline ARDS
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 13/08/2019
Actual trial start date 09/09/2019
Anticipated date of last follow up 19/12/2019
Actual Last follow-up date 30/12/2019
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 104
Recruitment status Withdrawn
Publication URL https://scholar.google.com/citations?user=vcn8u0sAAAAJ&hl=en
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization 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
Control Group intravenous normal saline 0.9 500 ml 2-3 days Received the standard pharmacotherapy of ARDS and 500 ml normal saline 0.9% intravenous over 24 26 Placebo
Control Group nebulizer 5 ml normal saline 0.9% (5ml) nebulizer /8hr 2-3 days : Received the standard pharmacotherapy normal saline 0.9% (5ml) nebulizer /8hr 26 Placebo
Experimental Group neublizer hypertonic saline 3% (5ml) nebulizer /8hr 2-3 DAYS : Received the standard pharmacotherapy for ARDS and hypertonic saline 3% (5ml) nebulizer /8hr 26
Experimental Group intravenous 500 ml hypertonic saline 3 % over 24 h 2-3 DAYS Received the standard pharmacotherapy of ARDS and 500 ml hypertonic saline 3 % over 24 h 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
both sexes age of 18-60 years fulfilling Berlin definition of ARDS as follows: Presence of heart failure or evidence of fluid overload renal failure hyperventilate patient refuse to anticipate Adolescent: 13 Year-18 Year,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 01/09/2019 Faculty of Medicine Ain Shams University Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine-abassia-Cairo-Egypt cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome decrease in Lung injury score which was calculated every 24 hours every 24 hours
Secondary Outcome Incidence of the need for mechanical ventilation within 14 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams university hospital albassia- faculty of medicine -ain shams university -Cairo-Egypt cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor amr sobhy abdelkway elmakollen elarab-elnozha cairo 11843 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
mohammed kamal naser city -rabaa cairo 11759 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator AMR SOBHY dr.amrsobhy2013@gmail.com 0020163394383 elmokwleen elarab
City Postal code Country Position/Affiliation
cairo 11843 Egypt lecturer ain shams university
Role Name Email Phone Street address
Public Enquiries mohammed kamal dr_medo2000@hotmail.com 00201009998643 rabeaa
City Postal code Country Position/Affiliation
cairo 11765 Egypt lecturer Ain shams university faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries AMR SOBHY dr.amrsobhy2013@gmail.com 00201063394383 elmokwleen
City Postal code Country Position/Affiliation
cairo 11843 Egypt lecturer Ain shams university faculty of medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes results and comment will be added after finishing Study Protocol within 6 month hpertonic saline in ARDS
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