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.: PACTR201701001873405 Date of Approval: 16/11/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Intraoperative use of ultrasound as a predictor of hypovolemia in children
Official scientific title Sonographic measurement of inferior vena cava as a predictor of hypovolemia in children undergoing major operation
Brief summary describing the background and objectives of the trial To assess the use of ultrasound as a noninvasive tool to predict hypovolemia in children undergoing major operation instead of the traditional use of invasive central venous line.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System,Early detection of hypovolemia.
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 11/08/2013
Actual trial start date 06/01/2014
Anticipated date of last follow up 30/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 100
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2065/09/13 Tanta university ethical commette department
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 (please state block size and whether or not the block size was variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group B Preoperative , every 15 minute intraoperative and 1 houre postoperative We use pulse ,blood pressure and central venous line as predictor of hypovolemia 50 Active-Treatment of Control Group
Experimental Group Groupe U Preoperative ,every 15 minute intraoperative and 1 houre postoperative We use inferior vena cava ,pulse ,blood pressure as predictor of hypovolemia 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I,II. Cheldren of both sexless than 12 years. respiratory,hepatic and renal dysfunction. abdominal surgery. patients who are not suitable for ultrasound visualization of IVC. 2 Year(s) 12 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 28/10/2013 Tanta university
Ethics Committee Address
Street address City Postal code Country
El Gish Street Tanta El Gharbia Egypt Tanta Egypt
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 28/10/2013 Tanta university
Ethics Committee Address
Street address City Postal code Country
El Gish Street Tanta El Gharbia Egypt Tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome dignostic value of infereo vena cava diameter as a predictor of hypovolemia preoperative. intraoperative every 15 minute. 1 hour postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
pediatric surgery departement ,Tanta University hospital. El Gish Street Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University El Ghish street Tanta. Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Department of anesthesia and surgical ICU.E El Ghish street Tanta 31577 Egypt Hospital
Primary Sponsor Tanta university El Ghish street Tanta 31577 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Lobna Abo El Naser El Nady street Tanta 31577 Egypt
Ahmed Aly El-Daba El Estad Street Tanta 31577 Egypt
Heba Mohammed El Sayed Morsy. ElAgizy Street Tanta 31577 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Heba Morsy dr.hebamorsy1@gmail.com 01006856298 El Agizy street
City Postal code Country Position/Affiliation
Tanta 35177 Egypt
Role Name Email Phone Street address
Public Enquiries Lobna Abo Elnaser Lobnaabonasr20@gmail.com 01222801691 El Nady street
City Postal code Country Position/Affiliation
Tanta 35177 Egypt
Role Name Email Phone Street address
Scientific Enquiries Ahmad El Daba go2eldaba@yahoo.com 01223433573 El Nady street
City Postal code Country Position/Affiliation
Tanta 35177 Egypt
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
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