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.: PACTR202007901764021 Date of Approval: 17/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Goal Directed Fluid Therapy Using Cardiometry Monitor in Patients Undergoing Major Spine Surgery in The Prone Position
Official scientific title Goal Directed Fluid Therapy Based on Stroke Volume Variation and Oxygen Delivery Index in Patients Undergoing Major Spine Surgery in the Prone Position
Brief summary describing the background and objectives of the trial The primary outcome is to evaluate whether a Goal Directed Fluid Therapy (GDFT) protocol will be effective in reducing perioperative red blood cells transfusions. The secondary outcome is to compare the effects of Goal Directed Fluid Therapy with conventional fluid therapy as regards total amount of fluids transfused, perioperative complications and postoperative length of ICU stay.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Devices
Anticipated trial start date 01/06/2020
Actual trial start date 15/05/2020
Anticipated date of last follow up 01/09/2020
Actual Last follow-up date 15/09/2020
Anticipated target sample size (number of participants) 48
Actual target sample size (number of participants) 48
Recruitment status Active, not 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 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
Control Group Liberal fluid therapy every 20min perioperative liberal fluid therapy based on BP,UOP and CVP readings. 24 Active-Treatment of Control Group
Experimental Group Goal directed fluid therapy basal and every 20min perioperative Goal directed fluid therapy based on SVV and Do2I using cardiometry device 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. American Society of Anesthesiologist (ASA) status I-II. 2. Posterior spine arthrodesis involving at least 5 vertebral instrumentational levels. 3. Age between 15 and 65 years. 4. A planned postoperative intensive care unit admission 1. Patients with known heart disease or any cardiac arrhythmia. 2. Patients with any abnormality in baseline coagulation test, creatinine or liver enzymes. 3. Patients with vascular lesions Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 15 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 08/06/2019 Ethics Commiteefaculty of medicineuniversity of alexandria
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine, 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 to evaluate whether a Goal Directed Fluid Therapy (GDFT) protocol will be effective in reducing perioperative red blood cells transfusions. single
Secondary Outcome to compare the effects of Goal Directed Fluid Therapy with conventional fluid therapy as regards total amount of fluids transfused, perioperative complications and postoperative length of ICU stay. single
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Alexandria university 1 Champlion street,Alexandria, Egypt Alexandria 21131 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Islam Hassan Omar Fathalla ElAwamy street, elagamy Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor faculty of medicine alexandria university 1 Champollion street,Khartoum square,Alexandria Alexandria 21131 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Islam Omar smsmsmsm10090@gmail.com +201227851759 Fathalla El awamy street,alexandria
City Postal code Country Position/Affiliation
alexandria 21500 Egypt assisstant lecturer of anaesthesia and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Ahmed Abdo smsmsmsm10090@gmail.com +201119277287 Elgeish street,Gleem,Alexandria
City Postal code Country Position/Affiliation
alexandria 21500 Egypt Professor of anaesthesia and surgical intensive care
Role Name Email Phone Street address
Scientific Enquiries Rabab saber smsmsmsm10090@gmail.com +201223497339 Victor Emanuel st.
City Postal code Country Position/Affiliation
alexandria 21500 Egypt Assisstant professor of anaesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the participant will be de-identified first but other data as in texts,tables,figures and appendages Informed Consent Form,Statistical Analysis Plan,Study Protocol the data will be available and provided 3 months after the trial publication and will remain available for 2 years after the trial publication the investigators will gain access to the trial details and data if they provide reasonable related and relevant proposal and that will be done only after the publication of the trial.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
smsmsmsm10090@gmail.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