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.: PACTR202402909858685 Date of Approval: 15/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Renal protective effect of dexmeditomidine in patients undergoing abdominal aortic surgeries
Official scientific title Renal protective effect of dexmeditomidine in patients undergoing abdominal aortic surgeries
Brief summary describing the background and objectives of the trial It is strongly advised to preserve renal function during aortic reconstructive surgery because aortic cross-clamping causes acute kidney injury and causes notable hemodynamic changes that affect renal function Therefore, the best way to protect kidneys during and after aortic cross-clamping is to maintain optimal systemic hemodynamics, adequate fluid resuscitation is also necessary, and the use of renal protective agents. Dexmedetomidine, is a selective alpha 2-adrenoceptor agonist, that is used as a sedative and analgesic drug, and it is also known as a renal protector, as it improved the renal hemodynamics through vasodilatation, and also may improve sodium and water regulation, so, it may improve the course of acute kidney injury. Reduced urine output or elevated serum creatinine (s.Cr) are the standard criteria used to diagnose acute kidney injury. However, a number of new and potentially helpful biomarkers of AKI- and failure have been identified recently, including neutrophil gelatinase-associated lipocalin, N-acetyl-b-D-glucosaminidase, interleukin-18, cystatin C and kidney injury molecule-1 I (KIM-1) We hypothesized that dexmedetomidine may reduce postoperative acute kidney injury represented by kidney injury molecule -1 in patients undergoing elective abdominal aortic surgery. AIM: the aim of this work is to study the effect of dexmedetomidine on renal protection on patients undergoing elective abdominal aortic surgery. OBJECTIVES: The primary outcome is to measure the urinary Kidney injury molecule -1 as a predictor of acute kidney injury, while the secondary outcome is to measure creatinine clearance, serum creatinine, urea, BUN, Haemodynamic parameters, and the need for postoperative renal dialysis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/02/2024
Actual trial start date
Anticipated date of last follow up 15/09/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 52
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group dexmedetomidine Continuous infusion of dexmedetomidine intraoperatively Infusion dose of 0.5 µg/kg/h Intraoperative period The patients randomized to dexmedetomidine group will receive continuous infusion of dexmedetomidine initiated at the start of surgery of an infusion dose of 0.5 µg/kg/h and maintained during aortic cross clamping and till the end of the surgery 26
Control Group control Continuous infusion of saline 0.125 ml/kg/h Intraoperative period The patients randomized to control group will receive continuous infusion of saline initiated at the start of surgery and maintained during aortic cross clamping and till the end of the surgery. 26 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
American Society of Anaesthesia (ASA) physical status class II – III Age from 40-65 years Elective aortobifemoral bypass surgery utilizing a synthetic graft under general anaesthesia. severe renal impairment (chronic kidney disease stage III or IV) renal artery stenosis or atherosclerosis previous renal surgery, single kidney suprarenal cross clamping severe hepatic insufficiency and emergency surgery. Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 65 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 25/12/2023 The scientific research ethics committee of kafrelsheikh university
Ethics Committee Address
Street address City Postal code Country
kafr El sheikh university El geish road- kafr el sheikh governorate- Egypt Kafrelsheikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to measure the urinary Kidney injury molecule -1 as a predictor of acute kidney injury following aortic cross clamping in abdominal aortic aneurysm baseline before surgical incision, at end of surgery, 12 hours postoperative ,24 hours postoperative
Secondary Outcome - Serum creatinine. - Urea and blood urea nitrogen - Creatinine clearance. baseline before surgical incision, at end of surgery, 12 hours postoperative ,24 hours postoperative
Secondary Outcome Haemodynamic parameters: - Heart rate (beats/min). - Invasive mean arterial blood pressure (mmHg). Before induction of anesthesia. Before aortic cross clamping, During aortic cross clamping, After release of aortic cross clamping, end of surgery, 6,12,24 hours after surgery
Secondary Outcome Postoperative need for renal dialysis. 48 hours after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh university hospital Mubarak Rd, Kafr Abu Tabl, Kafr Al Sheikh First, Kafr El-Sheikh Governorate, Egypt Kafrelsheikh 33516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
kafrelsheikh university Kafreelsheikh university- El-Geish road- Kafrelsheikh city- Kafrelsheikh governorate - Egypt Kafrelsheikh 33511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor kafreelsheikh kafrelsheikh university- El Geish Road- Kafrelsheikh city- Kafrelsheikh Governorate- Egypt kafrelsheikh 33511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dalia Elhefny daliaelhefny255@gmail.com +201223563217 650 elhorreya street- janaklees- Elraml
City Postal code Country Position/Affiliation
Alexandria 21532 Egypt Lecturer of Anesthesia and Surgical ICU Faculty of Medicine Kafrelsheikh University
Role Name Email Phone Street address
Public Enquiries Mohamed Abdelaal malaal2@hotmail.com +201001422577 kafreelsheikh university- El Geish Road- Kafrelsheikh city- Kafrelsheikh Governorate- Egypt
City Postal code Country Position/Affiliation
kafrelsheikh 33511 Egypt Professor of cardiothoracic surgery Kafrelsheikh university Egypt
Role Name Email Phone Street address
Scientific Enquiries Mohamed Kotb m_kotb_86@hotmail.com +201009538356 smouha Alexandria Egypt
City Postal code Country Position/Affiliation
Alexandria 21311 Egypt Lecturer of Anesthesia and surgical ICU kafrelsheikh university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification will be available to anyone who wishes to access the data, for any purpose, immediately following publication with no end date, via email of the principle investigator. Renal function parameters: - Serum creatinine. - Urea and blood urea nitrogen - Creatinine clearance. - Urinary kidney injury molecule. Haemodynamic parameters: - Heart rate (beats/min). - Invasive mean arterial blood pressure (mmHg). Postoperative need for renal dialysis. Study Protocol 1 year after publication Mail
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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