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.: PACTR201801002862138 Date of Approval: 12/12/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Goal Directed Fluid Therapy during pancreaticoduodenectomy operation
Official scientific title Goal Directed Fluid Therapy during pancreaticoduodenectomy operation. Stroke volume variation Compared to Central Venous Pressure
Brief summary describing the background and objectives of the trial ¿ Some haemodynamic changes associating Whipple operation during the immediate perioperative period with both standard monitoring and electric cardiometry. ¿ Effect of adopting each method for monitoring and management on perioperative haemodynamic therapy, postoperative complications, intensive care unit stay and outcome. ¿ Practical use of electric cardiometry during major surgery and advantages and disadvantages associating its use, and if cardiometry can modify or replace the standard monitoring method.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied observation during surgery,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 04/12/2016
Actual trial start date 04/12/2016
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date 31/12/2017
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 randomisation Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group fluid guided by CVP Boluses of 3 ml/kg of colloid allover surgery and first two days in the ICU haemodynamic variables triggering ¿uid administration involve central venous pressure less than 5mmHg with or without urinary output less than 0.5 ml/ kg/h, an increase in heart rate more than 20% above baseline, a decrease in mean systolic blood pressure less than 20% below baseline. Boluses of 3 ml/kg of colloid will be administered until return to be more than 5 mmHg. Aim is to keep CVP between 20 Active-Treatment of Control Group
Experimental Group fluid guided by SSV(stroke volume variation Boluses of 3 ml/kg of colloid allover surgery and first two days in the ICU the SVV group, boluses of 3 ml/kg colloid solution will be given when SVV rise above 15% for more than 5 min (a sustained change during the previous five minutes) or until a positive response is observed (cardiac index (CI) increase above 10%) to the fluid challenge. If no response i.e. SVV still above 15%, repeated boluses until PVI is reduced to below 15%. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Adults scheduled for elective Whipple operations. ¿ ASA classification I and II. ¿ Cardiac co-morbidity. ¿ Severe coagulation disorder 18 Year(s) 60 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 01/01/2017 faculty of medicine
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar shebeen elkom 12345 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome investigate the electrical cardiometry parameters compared to parameters obtained from central venous catheterization and standard monitoring for fluid guided management during and after Whipple operation . allover surgery and first 2 dayes postoperative
Secondary Outcome ¿ Effect of adopting each method for monitoring and management on perioperative haemodynamic therapy, postoperative complications, intensive care unit stay and outcome first two dayes postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghfar street shebeen elkom 12345 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen abdelghfar street shebeen elkom 12345 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national liver institute yassen abdelghfar street shebeen elkom 12345 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Omar Abdelalim Omar yassen abdelghfar street shebeen elkom 12345 Egypt
Khaled Ahmed Yassen yassen abdelghfar street shebeen elkom 12345 Egypt
Eman Sayed Ibrahim yassen abdelghfar street shebeen elkom 12345 Egypt
Ahmed Aly Abdelaziz Ahmed yassen abdelghfar street shebeen elkom 12345 Egypt
Mohamed Tarek Aly Youssef yassen abdelghfar street shebeen elkom 12345 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed tarek drmhmdtarek21@gmail.com 0125845698 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkom 12345 Egypt resident
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 0125845698 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkom 12345 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Mohamed tarek drmhmdtarek21@gmail.com 0125845698 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkom 12345 Egypt resident
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information