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.: PACTR202108851027312 Date of Approval: 02/08/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title B-Natriueretic Peptide as an early diagnostic factor for sepsis-induced myocardial dysfunction in comparison with Cardiac troponins I & T
Official scientific title B-Natriueretic Peptide as an early diagnostic factor for sepsis-induced myocardial dysfunction in comparison with Cardiac troponins I & T
Brief summary describing the background and objectives of the trial Septic shock is a severe syndrome characterized by hemodynamic changes and dysfunction of one or several organs. Approximately 50% of patients admitted to an intensive care unit with hypotension due to sepsis survive, whereas the remaining 50% die of refractory hypotension or multiple organ dysfunction syndrome. In 10% to 20% of these patients with refractory hypotension, there is a clinical picture of low cardiac output due to severe myocardial dysfunction. The Challenging issue is to early detect the sepsis induced cardiomyopathy using B-natriueretic peptide in comparison with already known biomarkers like cardiac troponins T & I.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Early detection /Screening
Anticipated trial start date 25/01/2019
Actual trial start date 25/08/2019
Anticipated date of last follow up 25/08/2020
Actual Last follow-up date 24/08/2020
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Blood Sampling 21 days sampling for comparison between Troponins and B-NP 25 Uncontrolled
Experimental Group Blood Sampling 21 days sampling for comparison between Troponins and B-NP 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Age group: adult patients aged from 21 – 60 years old o Sex : males and females o Admitted to ICU and Fulfilling sepsis criteria (Surviving Sepsis Campaign 2012) ▪ Temp >38°C or < 36°C ▪ Heart rate > 90 bpm ▪ Respiratory rate > 20 or PaCO2 < 32 mm Hg ▪ WBC > 12,000/mm3, < 4,000/mm3, or > 10% bands ▪ Present source of infection. ▪ Lactate > 2 mmol/L ▪ SBP < 90 or SBP drop ≥ 40 mm Hg of normal o Patients with comorbid cardiac disease. ▪ Congenital Heart Disease. ▪ Ischaemic heart disease with impaired cardiac function. ▪ Valvular heart disease. ▪ Infective endo-carditis. o Patients with comorbid renal impairment. o Patients with advanced Malignancy. o Post arrest patients. o Septic shock patients 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 25/08/2019 Research Ethical Committee of Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Abbassia Square Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome early detection of sepsis induced myocardial dysfunction 1 year
Secondary Outcome Discharge 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams University Hospitals Abbasia square Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmad Salama Sayed Radwan 18 kirkstone crescent carlisle United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Abbasia Square Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Bahaa Eweis Hassan Nasr City Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Ahmad Salama Sayed Radwan ahmad.salama36@gmail.com 0047535352796 18 kirkstone cresent
City Postal code Country Position/Affiliation
Carlisle United Kingdom Assistant Lecturer
Role Name Email Phone Street address
Public Enquiries Ahmad Salama Sayed Radwan Ahmad.salama36@gmail.com 0047535352796 18 kirkstone crescent
City Postal code Country Position/Affiliation
Carlisle CA2 5QW United Kingdom Assistant Lecturer
Role Name Email Phone Street address
Principal Investigator Ahmad Salama Sayed Radwan Ahmad.salama36@gmail.com 004535352796 18 Kirkstone Crescent
City Postal code Country Position/Affiliation
Carlisle CA2 5QW United Kingdom Assistant Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data that will underlie the results reported in this protocol after deidentification Study Protocol 9 months starting from July 2021 Investigators whose proposed use of the data has been approved by an independent review committee
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