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.: PACTR202308864962981 Date of Approval: 10/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Brain natriuretic peptide as an early predictor of toxic myocarditis after burn: A prospective observational study
Official scientific title Brain natriuretic peptide as an early predictor of toxic myocarditis after burn: A prospective observational study
Brief summary describing the background and objectives of the trial Thermal injury is a serious medical, social and economic problem. It is related to the complexity and duration of treatment of the patients, frequent disability and high mortality. Thermal trauma is accompanied by a number of disorders all over the body as a whole and, in particular, cardiac disorders. Burn toxins initiate a systemic inflammatory cascade that causes inflammation in cardiac myocytes, which in turn will cause transient cardiac contractile dysfunction In this study we hypothesis that the measurement of the plasma concentration of Brain Natriuretic peptide (BNP)– a hormone released from cardiac cells in case of cardiac distension – may predict early occurrence of toxic myocarditis.
Type of trial Observational
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Injury, Occupational Diseases, Poisoning
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/12/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
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
Single Group Non-randomised 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 Blood samples for the measurement of BNP and troponin level will be obtained from the central line sample of 4 ml blood on day 1, day 4 , day 7 for two weeks from admission ❖ Blood samples for troponins will be obtained simultaneously on the same days of BNP sampling to detect which test will rise first. ❖ Daily follow up of total leucocytic count and body temperature to detect early signs of sepsis. ❖ Daily measurement of vital signs( Heart rate , Systolic and diastolic blood pressure , Peripheral O2 saturation, Central venous pressure ) will be recorded every hour all through the day then consider the mean of each sign. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Age: eligible ≥ 21 - ≤ 60 yrs. 2- Sex: eligible both sexes. 3- Patients with American Society of Anesthesiologists (ASA) physical status I-II. 4- Patients with Total Burn Surface area (TSBA) ≥ 20% up to ≤ 50% 5- Patients with 2nd degree burn or more. 1- < 21 or > 60 years old. 2- Declining to give written informed consent. 3- Patients with preexisting cardiac or pulmonary diseases e.g., hypertension, congenital heart disease, ischemic heart disease with impaired cardiac function, valvular heart disease, heart failure, infective endocarditis. 4- Patients with severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2). 5- Patients with renal dysfunction (GFR < 50ml/min). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 02/09/2022 Research Ethics Committee at the faculty of medicine Ain shams university
Ethics Committee Address
Street address City Postal code Country
38 Abbasyia square , next to elnour mosque cairo 11812 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome ❖ The primary outcome will be the sensitivity and specificity of the BNP plasma level as an early predictor of the incidence of toxic myocarditis day 1 , day 4 , day 7
Secondary Outcome the secondary outcomes will be the incidence of other complications such as sepsis and other organ failure as well as ICU stay and total hospital stay. Icu and total hospital stay
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine ain shams university 38 Abbasiya square , next to El nour mosque , Cairo , Egypt cairo 11812 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
the principle investigator 374 gardenia city cairo 11756 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine Ain Shams University 38 Abbasyia square , next to el nour mosque cairo 11812 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Israa Tarek Mohamed 374 Gardenia city zahraa nasr city cairo 11756 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Israa Tarek israat93@yahoo.com 201068511575 374 gardenia city Zahraa nasr city
City Postal code Country Position/Affiliation
cairo 11756 Egypt Assistant lecturer at department of Anasethsia faculty of medicine Ain shams university
Role Name Email Phone Street address
Public Enquiries Marwa Khairy mar_khairy@yahoo.com +201006518802 47 elhegaz street , heiloples
City Postal code Country Position/Affiliation
cairo 11923 Egypt Assistant Professor at department of anasethsia faculty of medicine ain shams university
Role Name Email Phone Street address
Scientific Enquiries Hanan Farag faraghanan@yahoo.com +201221004795 155 moustafa elnahas street , nasr city
City Postal code Country Position/Affiliation
cairo 11756 Egypt Professor of anasethsia faculty of medicine Ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article , after deidentification Study Protocol Immediately following Publication No end date Anyone who wishes to access the data for any purpose Data will be available indefinitely at http://asja.springeropen.com/
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http://asja.springeropen.com/ 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