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.: PACTR201606001690779 Date of Approval: 21/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Remote ischemic preconditioning in prevention of acute kidney injury
Official scientific title The efficacy of remote ischemic preconditioning in prevention of acute kidney injury post cardiac surgery on cardiopulmonary bypass
Brief summary describing the background and objectives of the trial Acute kidney injury (AKI) occurs in as many as 40% of patients after cardiac surgery and requires dialysis in 1% of cases. Our hypothesis will be that remote ischemic preconditioning (RIPC) would improve post operative renal outcome and reduce incidence of AKI?
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ACUTE KIDNEY INJUERY,Kidney Disease,Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 02/01/2016
Actual trial start date 24/01/2016
Anticipated date of last follow up 18/05/2016
Actual Last follow-up date 01/06/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
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 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group group C patients will be undergoing sham placement of the blood pressure cuff around the lower limb 20 Placebo
Experimental Group Group RIPC Remote ischemic preconditioning protocol will be induced by inflation of automatic blood pressure cuff above 200 mm Hg four 5-min cycles of lower limb to induce ischemia and 5-min reperfusion this cycle repeated three times before initiation of bypass 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Age ranged between 18 - 60 years. ¿ASA physical status: II and III. ¿Patients with airway and parenchymal lung disease. ¿Pulmonary hypertension more than 100 mmHg. ¿Immunodeficiency. ¿Haematological disorders. ¿Hepatic impairment. ¿Renal impairment. ¿Pregnancy. ¿Morbid Obesity. ¿Diabetic patient. ¿Patients with myocardial ischemia or infarction. ¿Patients with peripheral vascular disease. ¿Patient required deep hypothermic circulatory arrest. ¿Patients receiving drugs that interfere with the mechanism of RIPC i.e. sulfonylureas, nicorandil and propofol. 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 01/11/2015 Benha faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Farid Nada st Benha 13518 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neutrophil Gelatinase Associated Lipocalin (NGAL) before operation (baseline) and 2 hours post cardiopulmonary bypass
Secondary Outcome Serum creatinine baseline, 2h post-cardiopulmonary bypass and at 24, 48, 72 hours post bypass
Secondary Outcome Estimated glomerular filtration rate baseline, 2h after cardiopulmonary bypass and at 24, 48, 72 hours post bypass
Secondary Outcome Urine output 1 hr intraoperatively and every 6 hr
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Benha university Farid Nada benha 13518 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Benha university Farid Nada Benha 13518 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Benha university Hospitals Farid Nada st Benha 13518 Egypt Hospital
Secondary Sponsor Benha university Farid Nada Benha 13518 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Cardiothoracic department Farid Nada Benha 13518 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nabil Abd Elazim Mohamed dr.nabilemara@yahoo.com +201114189443 7 abo baker st gamgara
City Postal code Country Position/Affiliation
benha 13714 Egypt assistant lecturer
Role Name Email Phone Street address
Public Enquiries Ahmed Mostafa Abd El-Hamid bashaahmad@yahoo.com +201005204130 20 Ezz Eldin Omar st.
City Postal code Country Position/Affiliation
Giza 12111 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Saad Ibrahim Saad saadibrahim_7@yahoo.com +201223142889 Oman st. - Eldokki
City Postal code Country Position/Affiliation
Giza 12611 Egypt Professor 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