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.: PACTR201508001233590 Date of Approval: 11/08/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of sodium bicarbonate on the lower respiratory tract pathogens
Official scientific title Effect of bronchoalveolar lavage with sodium bicarbonate 8.4 % on the retrieved lower respiratory tract pathogens
Brief summary describing the background and objectives of the trial All microbes grow within a particular range of external pH. pH had played many key roles in the development of microbiology. Change in local media can occur with infection as local acidosis, the abnormally acidic pH partially inhibited bacterial killing by ASL. In addition, gram-negative bacteria have increased resistance to antimicrobial peptides when grown at low pH The aim of this work is to evaluate the effect of bronchoalveolar lavage (BAL) with sodium bicarbonate 8.4% versus BAL with saline 0.9% on the retrieved lower respiratory tract pathogens.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied lower respiratory tract infections,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 12/03/2014
Actual trial start date 12/03/2014
Anticipated date of last follow up 30/05/2015
Actual Last follow-up date 30/05/2015
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 93
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 Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group BAL saline 0.9% followed by BAL withSB 8.4% 50 ml of each once 66
Experimental Group BAL with only 10 ml of saline (sample A) followed by BAL with 50 ml SB 8.4% (sample B) followed by B 10 ml saline, followed by 50 ml SB, then 50 ml saline once 13
Experimental Group BAL with saline 50 ml saline, then the retrieved BAL was divided into two containers with equal volume. Sample A was diluted with the same volume of saline 0.9% and the sample B was diluted with equal volume of SB 8. once 14
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with clinical and radiological pictures suggestive of lower respiratory tract infections (LRTI) age more than 18 years fit for fiberoptic bronchoscopy (FOB) Patients with no radiological signs of LRTI those unfit for FOB 18 Year(s) 75 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 08/06/2015 MMREC
Ethics Committee Address
Street address City Postal code Country
Elgomhoria Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean pH for saline versus bicarbonate samples immediately after BAL
Primary Outcome microorganisms retrieved from BAL samples of the studied groups according to the type of pathogen retrieved
Primary Outcome CFU for bacteria and fungi retrieved from BAL samples according to pathogen retrieved
Primary Outcome Ziehl¿Neelsen stain and tuberculosis culture within 4-8 weeks
Secondary Outcome Safety of the procedure: Immediately after instillation of SB and for the next 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
chest department Elgomhoria Mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
no funding source
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Chest medicine department- Mansoura faculty of medicine Elgomhoria Mansoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohammad Khairy El Badrawy Haielgamaa Mansoura 35511 Egypt
Mohammad Ahmad Abou Elela Salah Salem Talkha-Mansoura 35511 Egypt
Noha Tharwat Abou El-khier Qanatelswis Mansoura 35511 Egypt
Taha Taha Abdelgawad Haielgamaa Mansoura 35511 Egypt
Amro Abdelhamid Moawad Haielgamaa Mansoura 35511 Egypt
Aida Mahmoud Yousef Qanatelswis Mansoura 35511 Egypt
Dina Abouelkheir AbdAlla Toril Mansoura 35511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad Khairy El Badrawy profkhairy2008@yahoo.com +2 01114725911 Haielgamaa
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Professor of Chest Medicine- Faculty of Medicine ¿ Mansoura University
Role Name Email Phone Street address
Public Enquiries Dina Abouelkheir AbdAlla dkhair@mans.edu.eg +2 01009976012 Toril
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of Chest Medicine- Faculty of Medicine ¿ Mansoura University
Role Name Email Phone Street address
Scientific Enquiries Dina Abouelkheir AbdAlla dkhair@mans.edu.eg +2 01009976012 Toril
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of Chest Medicine- Faculty of Medicine ¿ Mansoura University
REPORTING
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Result URL Hyperlinks
Changes to trial information