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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201703002071249 Date of Registration: 03/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Role of Base Deficit in Resuscitation of Polytraumatized Patients Presented by Hypovolemic Shock
Official scientific title Role of Base Deficit in Resuscitation of Polytraumatized Patients Presented by Hypovolemic Shock
Brief summary describing the background and objectives of the trial The current ATLS system was designed for the initial management of severely injured trauma patients and has become the unofficial gold standard worldwide. Delayed treatment of hypovolemic shock leads to adverse outcomes, such as organ dysfunction and increased mortality Thus, for each class of shock (class I to IV), ATLS recommends a specific requirement (crystalloid ± blood) to manage the presumed level of hemorrhage. However, The ATLS classification system may not accurately reflect the degree of hemorrhage. These findings suggested that the current system may overestimate the degree of tachycardia in relation to hypotension and underestimate mental status changes thus enhances us to develop new method for classification of hemorrhagic shock as regard metabolic markers as base deficit. Aim of the present study: To know the prognostic significance of post trauma base deficit and to validate base deficit based classification in polytraumatised patients presented by hypovolemic shock.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied management of severely injured trauma patients with hypovolemic shock,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/03/2015
Actual trial start date 01/04/2015
Anticipated date of last follow up 01/10/2015
Actual Last follow-up date 01/10/2015
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 160
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 Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group - Group ¿ On admission to emergency room (ER), complete history taking including: age, sex, previous medical disease, mechanism of injury (rode traffic accident, falling from height, stab wound or gunshot) were recorded. Rapid clinical examination including vital data, neurological, chest, heart, abdominal examination , abdominal sonography of trauma was done for hemodynamic unstable patients and computed t 50 Active-Treatment of Control Group
Experimental Group - Group ¿¿ On admission to emergency room (ER), complete history taking including: age, sex, previous medical disease, mechanism of injury (rode traffic accident, falling from height, stab wound or gunshot) were recorded. Rapid clinical examination including vital data, neurological, chest, heart, abdominal examination , abdominal sonography of trauma was done for hemodynamic unstable patients and computed t 42 Active-Treatment of Control Group
Experimental Group - Group ¿II On admission to emergency room (ER), complete history taking including: age, sex, previous medical disease, mechanism of injury (rode traffic accident, falling from height, stab wound or gunshot) were recorded. Rapid clinical examination including vital data, neurological, chest, heart, abdominal examination , abdominal sonography of trauma was done for hemodynamic unstable patients and computed t 36 Active-Treatment of Control Group
Experimental Group - Group IV On admission to emergency room (ER), complete history taking including: age, sex, previous medical disease, mechanism of injury (rode traffic accident, falling from height, stab wound or gunshot) were recorded. Rapid clinical examination including vital data, neurological, chest, heart, abdominal examination , abdominal sonography of trauma was done for hemodynamic unstable patients and computed t 32 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients age more than 16 years, patents suffering from multiple trauma, abbreviated injury score ¿ 3, Glasgow coma scale > 8, and patients presented with hemorrhagic shock, who were suspected to be shocked if they had visible source of major bleeding; altered mental status; cold, clammy, pale, skin; tachycardia; capillary refill time > 3 seconds; systolic blood pressure < 90mm Hg : patients referred from other hospital, Patients were died during resuscitation or within first 24 hours, Patients presented with flail chest, and Patients had history of diabetes mellitus, renal, liver or heart disease. 16 Year(s) 70 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 25/02/2015 Tanta university faculty of medicine research ethics comittee quality assurance unit - Tanta Elbahr St
Ethics Committee Address
Street address City Postal code Country
Elbahr St Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome rterial blood gasses (BD), Systolic and diastolic Blood pressure, Heart rate in the first 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta Univercity Hosital Elbahr St Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta university hospital Elbahr St Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta Univercity Hospital Elbahr St Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Mohamed Mogahed Elmoatasem St Tanta Egypt
Islam Gamal Hassna Elbahr St Tanta Egypt
Dr. Yasser Amr Elmahalla St Elmahalla Egypt
Dr. Ahmed Sobhi Hassan Radwan St Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Sobhi Sob_ahmed@yahoo.cm 020403416621 Hassan Radwan
City Postal code Country Position/Affiliation
Tanta Egypt Professor of Anesthesiology and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Mona Mogahed monamogahedfr@hotmail.com 020403292202 Elmoatasem St
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of Anesthesiology and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Islam Hassona Igher86@gmail.com 0200403320644 Elbahr St
City Postal code Country Position/Affiliation
Tanta Egypt Intesivest
Role Name Email Phone Street address
Scientific Enquiries Yasser Amr yasser.amr@gmail.com 0200403360300 Elmahalla St
City Postal code Country Position/Affiliation
Tanta Egypt Professor of Anesthesiology and surgical intensive care
REPORTING
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