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.: PACTR201610001826216 Date of Approval: 17/10/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Remote ischemic preconditioning and acute kidney injury
Official scientific title Role of remote ischemic preconditioning on acute kidney injury reduction after hepatobiliary surgeries, a prospective randomized double blinded controlled study
Brief summary describing the background and objectives of the trial Acute kidney injury (AKI) is a broad clinical syndrome ranging from mild alteration in kidney function biochemical markers level to overt kidney dysfunction. AKI is associated with increased morbidity and mortality including accelerated progression to end-stage renal disease and death .AKI is associated with increased cost and hospital stay . Post-operative AKI is extensively studied in cardiac surgeries with limited studies in non-cardiac surgeries as major abdominal surgeries confirmed that AKI is common after major abdominal surgeries and associated with increased mortality Ischemic preconditioning refers to a mechanism in which a prior, short, ischemic period induces some protection against a subsequent prolonged ischemic and reperfusion damage. This can be done by remote organ ischemia (upper limb or lower limb) . In this study we will assess if remote ischemic preconditioning will affect incidence of acute kidney injury after hepatobiliary surgeries. ¿ We hypothize that remote ischemic preconditioning will reduce the rate and the severity of acute kidney injury after hepatobiliary surgeries. This study aims to assess the impact of remote ischemic preconditioning on rate and severity of acute kidney injury after hepatobiliary surgeries (primary variable), also will assess impact of remote ischemic preconditi
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied acute kidney injury,Kidney Disease,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 18/10/2016
Actual trial start date 22/10/2016
Anticipated date of last follow up 18/04/2017
Actual Last follow-up date 22/04/2017
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
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 closed envelope technique in blocks of 12 Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control time of operation 60 Active-Treatment of Control Group
Experimental Group remote ischemic preconditioning Four sets of 5 min manual pressure cuff elevation to 200 mmHg 5 min Four sets of 5 min manual pressure cuff elevation to 200 mmHg separated by 5 minutes of release (Using the non-dominant hand) 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients candidate for elective hepatobiliary surgeries of either sex, age from 20 to 60 years, ¿ Patient refusal to enroll in the study. ¿ Peripheral vascular disease. ¿ Preoperative renal impairment or patients on renal replacement therapy 20 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 12/10/2015 IRB mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
gomhuria street mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome assess the impact of remote ischemic preconditioning on rate and severity of acute kidney injury after hepatobiliary surgeries day 1 and 2 postoperative
Secondary Outcome assess impact of remote ischemic preconditioning on hospital length of stay and one month mortality one month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
gastroentrology centre, mansoura university gihan street mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
gastroenterology centre mansoura iniversity gihan street mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor gastroenterology centre mansoura iniversity gihan street mansoura 35516 Egypt Hospital
Primary Sponsor mansoura faculty of medicine gomhuria mansoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
elrefaey kandeel gihan street mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator usama abdalla usamaelsayed20@Yahoo.com 01028842265 gihan
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries elrefaey kandeel refa3ey2@yahoo.com 01008158591 gihan
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries usama abdalla usamaelsayed20@Yahoo.com 01028842265 gihan
City Postal code Country Position/Affiliation
mansoura 35516 Egypt lecturer of anesthesia and intensive care
REPORTING
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Changes to trial information