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.: PACTR201909633074119 Date of Approval: 16/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluation of two different fluids regimens on central venous-to-arterial carbon dioxide difference (pco2 gap)
Official scientific title Evaluation of two different fluids regimens on central venous-to-arterial carbon dioxide difference (pco2 gap)
Brief summary describing the background and objectives of the trial Background: Measuring the mixed or central venous oxygen saturation (Scv O2) is the most popular marker used to detect occult tissue hypoperfusion. A reduction in (Scv O2) denotes that there is an elevation in systemic oxygen extraction and the presence of an insufficient systemic oxygen delivery (1). Recently, a novel marker of adequate tissue perfusion is central venous-to-arterial carbon dioxide gradient (PCO2 gap) as a useful alternative to detect improper flow state in spite of apparently adequate hemodynamic parameters (2).The (PCO2 gap) which have been known to be inversely related to cardiac output is confirmed as a good reflection of the ability of the venous blood flow to wash out the accumulated CO2 produced in tissues (3). The kind of fluid namely crystalloid or colloid solution that adequately optimize the patient cardiac output and thus improving systemic and microcirculatory blood flow is still under intense research (4). Aim of the study: the study will be conducted to evaluate two different fluids management during major orthopedic surgery on (PCO2 gap)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/05/2019
Actual trial start date
Anticipated date of last follow up 31/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 82
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group crystalloid therapy immediately before surgery till discharge from post-anesthesia care unit All patients will receive a baseline fluid therapy of 10 ml kg-1h-1 of crystalloids (lactated ringer solution). Additional fluid boluses of 250 ml of lactated ringer solution over 3-4 minutes will be given. 41 Active-Treatment of Control Group
Experimental Group colloid therapy immediately before start of surgery till discharge from post-anesthetic care uit All patients will receive a baseline fluid therapy of 10 ml kg-1h-1 of crystalloids (lactated ringer solution). Additional fluid boluses of 250 ml of hydroxy ethyl starch (Hes) (130/0.4) over 3-4 minutes will be given 41
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients scheduled for elective major orthopedic surgeries will be selected with the following inclusion criteria: ASA grade I-III, Age between 40-70 years old, who were to undergo major elective orthopedic surgery expected to last at least 4 hours. Exclusion criteria of the patients: overweight (BMI>35), left ventricular ejection fraction below 45%, significant cardiac arrhythmias, valvular lesions, coagulation disorders, perioperative renal insufficiency, impaired hepatic function, allergy to any drug used in this study, preoperative infection and pregnancy. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 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 18/04/2019 Ethics committee Faculty of medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
7 Champollion Street, El Messalah, Alexandria, Egypt. Alexandria 21568 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome central venous-to-arterial carbon dioxide difference (Pcv-aCO2) 10 minutes before surgery and hourly during surgery until discharge from the PACU
Secondary Outcome Central venous oxygen saturation (Scv O2) , lactate level and Hemodynamic variables: heart rate (beats/minute), mean arterial blood pressure (mmHg), central venous pressure (mmHg), oxygen saturation and urine output. hourly during surgery until discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ElHadara University hospital El Mostashfa El Italy St. El Hadara Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Tarek Ismail and Dr Rabab S. Mahrous 152 TIBA st. Sporting Alexandria 21617 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Tarek Ismail 152 TIBA st. Sporting Alexandria 21617 Egypt Individual
Secondary Sponsor Dr Rabab S. Mahrous Faculty of Medicine el sultan Hussein st., El shatby Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Rabab S. Mahrous Anesthesia Department, El Sultan Hussein El shatby, Faculty of Medicine, Alexandria University Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Tarek Ismail drtarek.anesth@gmail.com +201001467166 152 TIBA st. Sporting
City Postal code Country Position/Affiliation
Alexandria Egypt Lecturer of Anesthesia and Surgical Intensive Care Helwan University Egypt
Role Name Email Phone Street address
Public Enquiries Amal Mohamed amalasaic@gmail.com +201281560053 Faculty of Medicine, El Sultan Hussein St. Anesthesia Department
City Postal code Country Position/Affiliation
Alexandria Egypt Secretary of Research and opinion in Anesthesia and intensive care Journal
Role Name Email Phone Street address
Scientific Enquiries Tarek Salem tareksalem00@gmail.com 00201112277417 Al Gamaa, Al Masaken Al Iqtisadeyah, Qism Helwan
City Postal code Country Position/Affiliation
Cairo Egypt Vice dean of graduate studies and Research
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes patients data after data entry in excel sheets. Analytic Code,Statistical Analysis Plan,Study Protocol additional documents will be available within 12 months after completion of the study. open access to IPD to reviewers. Data will be send directly by email upon request.
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