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.: PACTR202303692483097 Date of Approval: 22/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Perioperative Infusion of N (2)-L-alanyl-L-glutamine in Glycemic Control for Patients With Uncontrolled Diabetes Mellitus Presented for Urgent Coronary Artery Bypass Surgery: Randomized Control Trial
Official scientific title Efficacy of Perioperative Infusion of N (2)-L-alanyl-L-glutamine in Glycemic Control for Patients With Uncontrolled Diabetes Mellitus Presented for Urgent Coronary Artery Bypass Surgery: Randomized Control Trial
Brief summary describing the background and objectives of the trial Stress hyperglycemia is a term coined to describe transient hyperglycemia occurring in response to stressful conditions, As the severity of the hyperglycemic response increases with the magnitude of the stress, in cardiac surgery, the initial inflammatory response caused by anesthesia and surgery further peaks with CPB and hypothermia. In this study, we aimed to investigate the efficacy of perioperative infusion of N(2)-L-alanyl-L-glutamine in glycemic control for patients with uncontrolled diabetes presented for urgent coronary artery bypass surgery from aspects of intraoperative blood glucose levels and insulin requirement.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Cardiology,Circulatory System,Nutritional, Metabolic, Endocrine,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/07/2022
Actual trial start date 01/08/2022
Anticipated date of last follow up 01/01/2023
Actual Last follow-up date 01/03/2023
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 93
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dipeptiven group infusion of 1.5 mL of dipeptiven per kg of body weight over 3 hours just before the start of surgery. ONCE infusion of 1.5 mL of Dipeptiven/kg body weight (equivalent to 0.3 g N (2)-L-alanyl-L-glutamine/kg body weight). The rate of infusion will be 0.1 gm/kg/hour to be finished over 3 hours just before the start of surgery. 46
Control Group Control group infusion of 1.5 mL/kg of normal saline 0.9% body weight. ONCE PLACEBO 47 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All urgent cases of coronary artery bypass surgery whether isolated or combined with mitral valve surgery. • Uncontrolled diabetes mellitus with Hb A1C >7.0 • ASA physical status 2-5 • Sex (males and females) • Age 18-70 years. • Patients are refusing to participate in the study. • Below 18 or above 60 years. • Patients with preoperative abnormal hepatic profiles identified by double average values of ALT/AST or bilirubin or hypoalbuminemia • Patients with preoperative renal impairment identified by serum creatinine of more than 1.7 mg/dL • Patient with a history of malignant tumors. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 03/07/2022 Ain shams university faculty of medicine research ethics committee FWA 000017585
Ethics Committee Address
Street address City Postal code Country
faculty of medicine 38 abbassyia square cairo Cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean intraoperative glucose level. blood glucose was done every hour then we calculate the mean
Secondary Outcome • Perioperative dynamic of troponin I at the end of the operation, 6 hours postoperative, 24 hours postoperative, and 48 hours postoperative.
Secondary Outcome • Total insulin infusion in first 24 hours sum of all insulin recieved in the first 24 hours
Secondary Outcome • Incidence of diabetic ketoacidosis first 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
cardithoracic academy Ain Shams university hospital 392 Ramsis street - El Wailli cairo 11588 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
farouk kamal eldin 137 mamdouh salem cairo 11599 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor cardiothoracic academy 392 ramsis street El Wailli cairo 11591 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Farouk Kamal Eldin dr.faoukkamal@med.asu.edu.eg +201066241179 137 mamdouh salem nasr city
City Postal code Country Position/Affiliation
cairo 11599 Egypt lecturer of anesthesia faculty of medicine Ain Shams university
Role Name Email Phone Street address
Principal Investigator Aya Hisham Mousa ayahisham@med.asu.edu.eg +201114555939 abd E Aziz Fahmy mis El Gadida
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia faculty of medicine Ain Shams university
Role Name Email Phone Street address
Public Enquiries Mohammed Mohsen mohamed_mohsen@med.asu.edu.eg +201204227780 5th settellment street 2
City Postal code Country Position/Affiliation
cairo Egypt lecturer of anesthesia faculty of medicine Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We are intenteded to share individual-participant and data will be available as de-identified individuals participant data (including data dictionaries) Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol starting three months after publication up to five years controlled access after request for principal investigator
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