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.: PACTR202002537852294 Date of Approval: 17/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Early Prediction of Acute Kidney Injury post operative
Official scientific title Early Prediction of Acute Kidney Injury with Cell Cycle Arrest Biomarkers Using Plethesmography Directed Fluid Management in Major Abdominal Surgery
Brief summary describing the background and objectives of the trial The primary outcome is to assess the capability of early prediction of acute kidney injury (defined as KDIGO stage ≥ 1) using urinary G1 cell cycle arrest biomarkers in patients undergoing major abdominal surgery managed by plethesmography based goal directed fluid therapy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Circulatory System,Kidney Disease,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/02/2020
Actual trial start date 27/01/2020
Anticipated date of last follow up 31/08/2020
Actual Last follow-up date 27/01/2020
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 0
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group standard fluid therapy patients will undergo major abdominal surgery and managed with intraoperative standard fluid therapy.Ringer acetate infused using the 4/2/1 rule. asseessment of the acute kidney injury in the postoperative period (two days). assessing the capability of early prediction of acute kidney injury (defined as KDIGO stage ≥ 1) using urinary G1 cell cycle arrest biomarkers in patients undergoing major abdominal surgery (two days postoperative). 20 Active-Treatment of Control Group
Experimental Group plethesmography based goal directed therapy colloid will be given over 5 minutes when pleth variability index (PVI) is higher than 13 % over 5 min and repeated until pleth variability index (PVI) returned to below 13% provided that the maximal allowable dose of voluven isn’t reached (20 ml/kg). assessing acute kidney injury in the postoperative period. (two days) Goal directed fluid therapy group using pleth variability index. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with physical status American Society of Anaesthesiologists (ASA) I and II who will be scheduled for elective major abdominal surgery (is defined as any surgery with intraperitoneal approach performed under general anesthesia and the predictable postoperative hospitalization and length of stay at least two days) with combined general epidural anaesthesia and will be admitted to Alexandria Main University Hospital. 1- Extremes of age (below 18 years and above 65 years). 2. Chronic kidney disease. 3. Perioperative use of nephrotoxic drugs. 4. Post-renal transplant patient. 10 5. Hepatic patient. 6. Cardiac patients. 7. Increased intra-abdominal pressure and abdominal laparoscopic surgery. 8. Diabetes mellitus. 9. Peripheral arterial occlusive disease. 10. Pregnancy. 11. Any plethesmography reading with a corresponding core temperature not within the range of 36 ± 1 ̊C at any time during the surgery. 12. Surgical patients at severe nutritional risk by the presence of at least one of (weight loss >10-15% within 6 months, BMI <18.5 kg/m2, preoperative serum albumin <3 g/dl with no evidence of hepatic or renal dysfunction).(21) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 64 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 21/02/2019 the ethics committee of the faculty of medicine
Ethics Committee Address
Street address City Postal code Country
1 champilion street alexandria 21563 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to assess the capability of early prediction of acute kidney injury (defined as KDIGO stage ≥ 1) using urinary G1 cell cycle arrest biomarkers in patients undergoing major abdominal surgery managed by plethesmography based goal directed fluid therapy. 4 h and 12 h after ICU admission.
Secondary Outcome The secondary outcome is to evaluate the postoperative impact of goal directed therapy in patients undergoing major abdominal surgery as regards:  The return of normal peristalsis.  Haemodynamic compromise episodes in the post-operative period.  The need of renal replacement therapy.  Length of hospital stay. at the end of the second postoperative day
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria university faculty of medicine 1 champolion street alexandria 21563 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
marwa medhat ahmed mahran 1 champilion street alexandria 21563 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alexandria university faculty of medicine 1 champilion street alexandria 21563 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amal Mohamed Sabry Ahmed 1 champilion street alexandria 21563 Egypt
Ahmed Youssef Aly Mohamed 1 champilion street alexandria 21563 Egypt
Ayman Fathy Khalifa Elsayed 1 champilion street alexandria 21563 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator marwa mahran marwamedhatmahran@gmail.com +201283155525 1 champilion street
City Postal code Country Position/Affiliation
alexandria 21563 Egypt anesthesia registrar alexandria university faculty of medicine.
Role Name Email Phone Street address
Public Enquiries maha ghanem alexmedethics@yahoo.com +201287740750 1 champilion street
City Postal code Country Position/Affiliation
alexandria 21563 Egypt head of the ethics committee Alexandria university faculty of medicine.
Role Name Email Phone Street address
Scientific Enquiries emad aida aridae@yahoo.com +201223129135 1 champilion street
City Postal code Country Position/Affiliation
Alexandria 21563 Egypt head of anesthesia department Alexandria university faculty of medicine.
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the participant will be de-identified first but other data as in texts, tables, figures and appendages. Informed Consent Form,Statistical Analysis Plan,Study Protocol the data will be available and provided 3 months after the trial publication and will remain available for 2 years after the trial publication. the investigators will gain access to the trial details and data if the provide a reasonable related and relevant proposal and that will be done only after the publication of the trial.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
marwamedhatmahran@gmail.com 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