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.: PACTR201902680224481 Date of Approval: 11/02/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Echocardiography-guided management of hemodynamics in severe sepsis and septic shock in adults.
Official scientific title Echocardiography-guided management of hemodynamics in severe sepsis and septic shock in adults: effects on 30 and 60 days mortality, vasopressor requirements, total fluid requirements, duration in hours to reach normal parameters of tissue perfusion, mechanical ventilation days and length of ICU stay.
Brief summary describing the background and objectives of the trial A prospective randomized trial comparing two different strategies, Echocardiography-guided hemodynamic management versus the Early Goal-Directed Therapy management of severe sepsis and Septic Shock in Adult patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Infections and Infestations
Sub-Disease(s) or condition(s) being studied Septic Shock
Purpose of the trial Early detection /Screening
Anticipated trial start date 01/03/2015
Actual trial start date 28/04/2015
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date 31/08/2016
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 87
Recruitment status Completed
Publication URL http://ncwegypt.mans.edu.eg/eulc_v5/Libraries/Thesis/BrowseThesisPages.aspx?fn=PublicDrawThesis&BibID=12536280
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Echocardiography 1-2 hours for the first 6 hours then 6 hourly for the first 24 hours. 24 hours from Enrollment in the Study Transthoracic bedside focused echocardiographic assessment of the patient as a baseline, parasternal long access, parasternal short access mid-papillary, apical 4/5 chamber and subcostal views in Five Step-approach. Step One was to detect potential signs of pre-existing chronic cardiac dysfunction that needs a full echocardiography study and exclude the patient from this study. Step Two was to assess both left and Right Ventricles contractility assessment by eyeballing categorizing into a hyperdynamic, Normal and poor function. Step Three: Left Ventricular Outflow Tract Velocity Time Integral ( LVOT VTI ) assessment by Echo Doppler and categorize patients into one of three categories Low, Normal and High Cardiac output. Step Four was to check for Fluid responsiveness and classify patients into fluid responsive or not fluid rsponsive depending on LVOT VTI pre and post passive leg raise test (If Velocity time integral measured on the left venticle outflow tract increases by more than 15% on passive leg raise test indicates patient is a fluid responder otherwise not responder). Step Five is Vasodilation as a diagnosis of exclusion. 50
Control Group Early Goal Directed Therapy Every hour for 24 hours 24 hours from enrollment In which the surviving sepsis campaign dependent resuscitation protocol was applied, targeting all of the following as a part of a stepwise treatment protocol: 
 A. 500-ml bolus of crystalloid was given every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg. B. If the mean arterial pressure was less than 65 mmHg, vasopressors were given to maintain a mean arterial pressure of at least 65 mmHg. C. If the central venous oxygen saturation was less than 70 per cent, red cells were transfused to achieve a hematocrit of at least 30 per cent. D. After the central venous pressure, mean arterial pressure, and hematocrit were thus optimized, if the central venous oxygen saturation was less than 70 per cent, Dobutamine administration was started at a dose of 2.5 μg per kilogram of body weight per minute, a dose that was increased by 2.5 μg per kilogram per minute every 30 minutes until the central venous oxygen saturation was 70 per cent or higher or until a maximal dose of 20 μg per kilogram per minute was given. E. Dobutamine was decreased in dose or discontinued if the mean arterial pressure was less than 65 mmHg or if the heart rate was above 120 beats per minute. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients aged 18 - 60 years admitted or planned for admission to intensive care unit Episode of septic shock will be included in the study. Patient refusal known history of any cardiac disease, Acute coronary syndrome Severe obesity (body mass index > 35) Severe respiratory disorders or high PEEP requirements on mechanical ventilation Multi-organ system failure Acute pulmonary edema Status asthmaticus Cardiac dysrhythmias (as a primary diagnosis) Contraindication to central venous catheterization Active gastrointestinal hemorrhage Do-not-resuscitate status and patients who show signs of chronic cardiac diseases in first Echocardiography. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 31/12/2014 Tanta University Faculty of Medicine Research ethics committee Quality assurance unit.
Ethics Committee Address
Street address City Postal code Country
Elbahr st., Tanta, Gharbia Governorate, Egypt Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mortality 30 days
Secondary Outcome Mortality 60 Days
Secondary Outcome Mechanical Ventilation days 30 days
Secondary Outcome ICU stay 30 days
Secondary Outcome The total fluid volume used First 24 Hours
Secondary Outcome Vasopressors dose The first 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital Algeish Street Tanta 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 Tanta University Hospital Tanta University Hospital, ElBahr Street Tanta Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Walid Saad Alhabashy Aly wsh2976@hotmail.com 00353894402228 18 Park Gardens, Hansfield wood, Clonsilla
City Postal code Country Position/Affiliation
Dublin Ireland Medical doctorate research student
Role Name Email Phone Street address
Public Enquiries Walid Saad Alhabashy Aly wsh2976@hotmail.com 353894402228 18 Park gardens Hansfield wood clonsilla
City Postal code Country Position/Affiliation
Dublin Ireland MD research student
Role Name Email Phone Street address
Scientific Enquiries Ahmed Saeid Algebaly Elgebaly_13@hotmail.com 00201005121944 Elbahr Street, Tanta
City Postal code Country Position/Affiliation
Tanta Egypt MD research supervisor Assistant Professor Tanta University Hospital Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mohammed Abdelghafar mohamedghafar76@yahoo.com 00201005406231 Tanta
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of Anaesthesia
Role Name Email Phone Street address
Scientific Enquiries Osama Shalaby Om_shalaby@yahoo.com 00201000560074 Tanta
City Postal code Country Position/Affiliation
Tanta Egypt Professor of Anaesthesia Faculty of Medicine Tanta University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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