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.: PACTR202402866059449 Date of Approval: 01/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy and Safety of empagliflozin in patients with hepatic ascites: a randomized controlled trial
Official scientific title Efficacy and Safety of empagliflozin in patients with hepatic ascites: a randomized controlled trial
Brief summary describing the background and objectives of the trial Although several therapeutic options exist, including neurohormonal and diuretic management, paracentesis, transjugular intrahepatic portosystemic shunting (TIPS), and transplantation, each modality is associated with significant risks and limitations. Sodium-glucose cotransporter 2 (SGLT2) inhibitors represent a relatively new class of medications for the management of type II diabetes mellitus. Dapagliflozin, empagliflozin, and canagliflozin are three drugs that target SGLT2 in the proximal tubule of the nephron, promoting increased excretion of both sodium and glucose in the urine. Trials examining the role of SGLT2 inhibitors in the co-management of diabetes and ascites in cirrhosis are necessary to test the hypothesis that these agents can safely attenuate the maladaptive neurohormonal and inflammatory responses. The aim of our study is to investigate the safety and efficacy of empagliflozin, a sodium glucose transporter 2 inhibitor, as an adjuvant therapy for ascites in patients with liver cirrhosis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/08/2023
Actual trial start date 16/08/2023
Anticipated date of last follow up 31/12/2024
Actual Last follow-up date 31/12/2024
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Empagliflozin 10 mg once daily 12 weeks the experimental group will recieve the standard thearpy (salt resitriction plus diuretics) plus eplagliflozin 10 mg once daily for 12 weeks. 30
Control Group Control 12 weeks The control group include patients with hepatic ascites who will recieve their tradiontal lines of treament includinhg rest, salt restriction, and diuretics. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. 18 years old or older. 2. Decompensated liver cirrhosis complicated with ascites. 3.Ability to understand and willingness to participate and sign a written informed consent document 1.age under 18 years old; 2.History of any attack of hypoglycemia (defined as serum glucose less than 70 mg/dl) either symptomatic or a symptomatic. 3.vitally unstable pt 4.Patients who receive non-selective B-blockers. 5.History of recurrent urinary tract infection defined as more than 2 infections in last 6 months 6.Pregnancy and breast feeding 7.History of hypersensitivity to any SGLT2 inhibitor 8.Presence of hepatocellular carcinoma or any other malignancy. 9.eGFR below 45mL/min/1.73m2 or decrease in eGFR by >30% between screening 10. Patients with history of diabetes mellitus complicated with diabetic ketoacidosis (DKA) or patients have any risk factors for DKA 12. History of alcohol intake Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 75 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 10/04/2023 Faculty of Medicine ethics committee AlAzhar University Assiut.
Ethics Committee Address
Street address City Postal code Country
Faisal St. Assiut 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1- Efficacy of empagliflozin in the management of hepatic ascites improvement in the form of decreased ascites by clinical follow-up and periodic abdominal ultrasound examination, weight assessment, and urine output. 2- side effects of empagliflozin including hypoglycemia, hepatic deterioration, increased ascites, urinary tract infection, and any other adverse effects. every 4 weeks during a 24-week period of the study in addition to a 8-week drug clearance period after empagliflozin therapy.
Secondary Outcome subgroup analyis according to age, sex, garde of hepatic decompenation and any other beficail subgroup analyisis. every 4 weeks during a 24-week study period in addition to a 8-week drug clearance period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
AlAzhar Assiut University Hospital. department of Hepatology and Gastroenetrology Faisal St. Assiut 71524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
None None Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor None None Assiut Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Muhammad AbdelGawad muhammad2013@azhar.edu.eg 00201113528652 Al-Rai St.
City Postal code Country Position/Affiliation
Assiut Egypt Associate Professor of hepatology gastroenterology and infectious diseases AlAzhar university Assiut Egypt
Role Name Email Phone Street address
Principal Investigator Mostafa Ismail mostafa.Isma@yahoo.com 00201005597878 AlGalaa St.
City Postal code Country Position/Affiliation
Assiut Egypt Assistant Lecturer of Heaptology gastroenterology and infectious diseases AlAzhar University Assiut Egypt
Role Name Email Phone Street address
Public Enquiries Khaled AbdelAzeem drkhaledabdelazeem@gmail.com 00201004575331 Sohag St.
City Postal code Country Position/Affiliation
Sohag Egypt Professor of Hepatology gastroenterology and infectious diseases AlAzhar University Assiut Egypt
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share all essentail data when requested from the prinicipal investigator. we will share our results and/or a link to it after completeion as recommended by the WHO. We intende to share all de-identified data of participants. Clinical Study Report within 12 months of the study completion date for 2 years. Any related data could be requested by PACTR or any other related authority, from the pricipal investgator by email. for any other sociaty or person the request will be reviewed by the authors and decided accordingly.
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