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.: PACTR202408886014501 Date of Approval: 12/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The impact of Perioperative Dexmedetomidine usage in prevention of Acute Kidney Injury in patients undergoing Whipple operations
Official scientific title The impact of Perioperative Dexmedetomidine usage in prevention of Acute Kidney Injury in patients undergoing Whipple operations ( randomized control study )
Brief summary describing the background and objectives of the trial acute kidney injury(AKI) is a common complication of patients undergoing major surgery and is associated with both short-term morbidity and mortality and longer-term adverse outcomes, including the development of CKD . AKI has been described as a sentinel surgical complication being associated with a higher incidence of many adverse outcomes, including a longer hospital length of stay, intensive care unit (ICU) admission,Dexmedetomidine, an α2-adrenoreceptor agonist, has been widely used in anesthesia procedures and intensive care. It inhibits inflammation, alleviates postoperative delirium, and exhibits neuroprotective effects. AKI incidence decreases after the use of dexmedetomidine in cardiac surgery. so the objectives of this study to detect the role of dexmedetomidine in prevention of AKI in patients undergoing whipple operation
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DEX AKI
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/04/2024
Actual trial start date 01/04/2024
Anticipated date of last follow up 01/01/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL anasthesia and analgesia journal
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control 0.2–0.7 μg/kg/h continuous infusion of normal saline initiated 1 hour before the surgical incision and continued till skin closure. 0.2–0.7 μg/kg/h continuous infusion of normal saline initiated 1 hour before the surgical incision and continued till skin closure. 25 Placebo
Experimental Group dexmeditomidine The dexmedetomidine infusion 0.2–0.7μg/kg/h continuous infusion . The dexmedetomidine infusion will be initiated 1 hour before the surgical incision and continued till skin closure. 0.2–0.7μg/kg/h continuous infusion perioperatively). The dexmedetomidine infusion will be initiated 1 hour before the surgical incision and continued till skin closure. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adult patients (18 years or older) undergoing Whipple surgery. Patients with pre-existing renal dysfunction (eGFR <60 mL/min/1.73 m2) Major intraoperative events (e.g. severe hemodynamic instability, massive blood loss, massive blood products transfusion). Allergy to Dexmedetomidine, unwilling to participate in the study will be excluded. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 01/03/2024 institutional review board
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar shebeen elkoom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome renal function tests urea and creatinine 24hr and 48hr postoperative
Secondary Outcome Urine output in the first 24 hours postoperatively. Incidence of delirium, hypotension, bradycardia, and prolonged mechanical ventilation within 48 hours postoperatively 24hr and 48hr postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar shebeen elkoom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen addelghafar shebeen elkoom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national liver institute yassen abdelghafar shebeen elkoom 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hanaa rashed hanaarashed2020@yahoo.com 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt anasthesia lecturer
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt anasthesia lecturer
Role Name Email Phone Street address
Scientific Enquiries hanaa rashed hanaarashed2020@yahoo.com 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkoom 23456 Egypt anasthesia lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing study protocol , aim of the work, patient and method and the results when be available.sharing of de-identified individual trial participant data. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol when the result will be available dexmeditomidine, AKI, whipple operation
URL Results Available Results Summary Result Posting Date First Journal Publication Date
in anasthesia and analgesia journals 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