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.: PACTR201801003000154 Date of Approval: 22/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Renal protective effect of dexmedetomidine in children undergoing cardiac surgery: A randomoized controlled study
Official scientific title dexmedtomidine and kidney function in children after cardiac surgery
Brief summary describing the background and objectives of the trial acute kidney injury (AKI) is a common complication of pediatric cardiac surgery with increased morbidity and mortality. dexmedetomidin, a selective alpha 2 adrenoreceptor agonist, has shown significant effect on reducing the postoperative renal injury in adult but never tried in children. we aimed to evaluate the renal protective effect of dexmedetomidine in pediatric cardiac surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Kidney Disease,kidney function during and after pediatric cardiac surgery,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2018
Actual trial start date 01/02/2018
Anticipated date of last follow up 31/07/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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 computer generated sealed opaque envelops Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedtomidine 0.5 microgram/kg/h IV over 15 minutes before induction of anesthesia then 0.5 microgram/kg/h for the entire operation period for 6 hours after surgery dexmedetomidine IV infusion 15 minutes before anesthesia to 6 hours after end of surgery 50
Control Group saline same amount of dexmedtomidine used in experimental group 15 minutea before and for 6 h after the end of the surgery saline infusion 15 minutes before anesthesia and for 6 h after end of the surgery 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
any child below 18 years that undergo cardiac surgery known allergy to dexmedetomidine, congestive heart failure, renal impairment, liver diseases, coagulation disorders, permanent pacemaker, history of preoperative bradyarrhythmias,diabetes 0 Year(s) 18 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 07/01/2018 local ethical committee of faculty of medicine, tanta university
Ethics Committee Address
Street address City Postal code Country
El geish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome incidence of acute renal injury at start of anesthesia, at the end of the surgery, 12, 24 h, 48 h after end of the surgery
Secondary Outcome side effects of the drug, duration of mechanical ventilation, ICU stay, hospital stay, and mortality. 24 h after and for 1 month after surgery.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospital El geish street Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
personal fund El motasem street tanta 31423 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital elgeish street tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Doaa El Amrousy El motasem street tanta 31522 Egypt
Mohamed El Kashlan El motasem street tanta 31522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Doaa El Amrousy doaamoha@yahoo.com 00201278155283 el motasem street
City Postal code Country Position/Affiliation
tanta 31522 Egypt assistant professor of pediatrics
Role Name Email Phone Street address
Public Enquiries Nagat Elshmaa nagat_elshmaa@yahoo.com 00201279999697 elgeish street
City Postal code Country Position/Affiliation
tanta 31527 Egypt associate professor of anesthesiology
Role Name Email Phone Street address
Scientific Enquiries mohamed Elkashlan mohamedkashlan@yahoo.com 00201222337746 el motasem street
City Postal code Country Position/Affiliation
tanta 31522 Egypt consultant of anesthesia
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