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.: PACTR202102891279505 Date of Approval: 25/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title An echo guided protocol for fluid resuscitation of sepsis patients in emergency department: clinical trial
Official scientific title An echo guided protocol for fluid resuscitation of sepsis patients in emergency department: clinical trial
Brief summary describing the background and objectives of the trial The use of bedside echo in the emergency department , noninvasive and rapid method to provide relevant diagnostic information on patients” hemodynamic status . it is suggested to be more accurate than the standardized strategy proposed by the Surviving Sepsis Campaign guidelines for the detection of features of the failing circulation. The use of bedside echo assessment to guide fluid therapy in septic shock patients is recommended . The objective of the study is to find if the suggested protocol will make a difference in the outcome of the patient as fluid boluses , early introduction of vasopressors , morbidity (end organ dysfunction) and secondary outcomes as ventilator free days , ICU free days and mortality. Also, to validate ECHO as a monitoring tool to guide fluid resuscitation in severe sepsis and septic shock (defined though QSOFA and SOFA score).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations,Severe Sepsis
Sub-Disease(s) or condition(s) being studied Septic shock
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2019
Actual trial start date 01/01/2020
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Echo guided protcol for fluid resuscitation During the emergency room (ER) stay Assessing for signs of overt hypovolemia and following up VTI variability to assess need for further boluses 30
Control Group Standard Care During the Emergency Room (ER) stay The use of ABCDE approach and NEWS score to clinically assess the patients for the need of fluid challenge and further boluses Repeated assessment of physiological clinical parameters and lactate to determine the need for further boluses. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Evidence of sepsis or septic shock according to new sepsis criteria. The presence of 2 or more qSOFA points near associated with source of infection: - Low blood pressure (SBP<100 or = mmhg) - High respiratory rate (RR = or 22 breaths /min ) - Altered mentation (GCS = or < 15) Known pregnancy Requirement for immediate surgery Hypotension attributed to alternative cause Extreme instability (periarrest, impending respiratory failure, need for intubation). Significant pathology of the chest or abdominal wall that would make transthoracic echocardiography impossible (burns, chest trauma, etc.). Patients resuscitated outside hospital. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 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 31/12/2018 Ethics Committee Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome amount of fluid boluses for resuscitation During Emergency Room Stay
Primary Outcome time for introduction of vasopressor During Emergency Room Stay
Primary Outcome SOFA score assessment Initial and after 48 hours
Secondary Outcome mortality Anytime
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Emergency Medicine Alexandria university hospital Champollion Street El-Khartoum Square El Azareeta Medical Campus Alexandria 21131 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sara Mohamed Basha Block 49 Street number 5 flat 50 Smouha Alexandria 21646 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine University of Alexandria Faculty of Medicine Champollion Street, ElKhartoum Square ElAzareeta Medical Campus Alexandria 21131 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Assem Abdeelrazik 542 Al Horreya avenue Gleem Alexandria 21624 Egypt
Tamer Abdallah Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
Ahmed Elamrawy Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
Mina Montasser Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
Sara Mohamed Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
Role Name Email Phone Street address
Principal Investigator Assem Abdrabu Assem.razek@gmail.com 00201222154828 542 Al Horreya avenue Gleem
City Postal code Country Position/Affiliation
Alexandria 21624 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Tamer Helmy tamer270103@hotmail.com 00201001986657 Faculty of Medicine, Champollion Street, El-Khartoum Square, El Azareeta Medical Campus
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Professor of Critical Care Faculty of Medicine University of Alexandria
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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