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.: PACTR201703002078398 Date of Approval: 06/03/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Conventional versus restricted regimens of fluid replacement
Official scientific title Comparative study between conventional and restricted regimens of fluid replacement using lung ultrasound in pediatric patients undergoing correction for proximal hypospadias
Brief summary describing the background and objectives of the trial Fluid management during surgery is one of the major aspects. Effective fluid management of the patient begins before the operation starts. The present study was designed to evaluate the differences between conventional and restricted regimens of fluid replacement using lung ultrasound in pediatric patients undergoing major abdominal surgeries
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Fluid therapy,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 02/03/2015
Actual trial start date 10/03/2017
Anticipated date of last follow up 15/11/2016
Actual Last follow-up date 01/12/2016
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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 Randomised Computer software program 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 CG group ringer lactate solution at the rate of 4ml/kg/h for first 10 kilograms of body weight and 2ml/kg/h for second 10 kilograms of body weight and 1 ml/kg/hr. for each further kilogram of the body weight Patients were administered with ringer lactate solution at the rate of 4ml/kg/h for first 10 kilograms of body weight and 2ml/kg/h for second 10 kilograms of body weight and 1 ml/kg/hr. for each further kilogram of the body weight. The deficit volume was calculated as the maintenance volume multiplied by fasting hours and given as following; 50% of the volume in first hour, 25% of the 40 Placebo
Experimental Group RG Group 3 ml/kg/h of ringer lactate solution from the starting of the surgery till the end. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
3-6 years Undergo major surgery Anemia Pulmonary disease Renal or hepatic disorders Any contraindication to general anesthesia Metabolic or nutritional disorders 3 Year(s) 6 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 02/02/2015 Anaesthesia Department Ethical Committee
Ethics Committee Address
Street address City Postal code Country
Kasr Elainy st. Cairo 11562
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Number of patients developed positive ultrasound lung findings and B-line count Postoperative
Secondary Outcome The recovery score Postoperative
Secondary Outcome urine output intraoperative
Secondary Outcome Hemodynamic paramerters Every 5 min. till 90 min.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo faculty of medicine Kasr Eleiny st. Cairo 12111 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo university Kasr Eleiny st. Cairo 11562 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo faculty of medicine Kasr Eleiny st. Cairo 11562 Egypt Hospital
Secondary Sponsor Cairo university Gamaa st. Giza 11697 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Pediatric surgery department Kasr Eleiny st. Cairo 11562 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elsonbaty jijsonbaty@yahoo.com +201097000067 Elharam st
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Ahmed Abd El-Hamid bashaahmad@yahoo.com +201005204130 20 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Professor
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim Saad saadibrahim_7@yahoo.com +201223142889 Oman st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
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