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CTRI Number  CTRI/2025/01/079132 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   To assess how effective Empagliflozin and Midodrine are in treating patients with refractory ascites. 
Scientific Title of Study   Efficacy of Empagliflozin and Midodrine in refractory ascites 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ganesh Bhat 
Designation  Professor and Head  
Affiliation  Manipal Academy of Higher Education  
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9900791615  
Fax    
Email  bhat.ganesh@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ganesh Bhat 
Designation  Professor and Head  
Affiliation  Manipal Academy of Higher Education  
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9900791615  
Fax    
Email  bhat.ganesh@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr V S Mohammed Fazil 
Designation  DM Resident  
Affiliation  Manipal Academy of Higher Education  
Address  Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  9985739786  
Fax    
Email  fazil.omc@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Academy of Higher Education, Manipal, Udupi Karnataka, India - 576104 
 
Primary Sponsor  
Name  Kasturba medical college MAHE 
Address  Department of gastroenterology and hepatology, Kasturba hospital, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganesh Bhat  New OPD, 4th Floor, Department of Gastroenterology and Hepatology, Kasturba Medical College  Manipal Academy of Higher Education, Madhav Nagar
Udupi
KARNATAKA 
9900791615

bhat.ganesh@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K768||Other specified diseases of liver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adults aged 18 to 75 years.

Decompensated liver cirrhosis with refractory ascites. 
 
ExclusionCriteria 
Details  Patient with contraindication to midodrine and empagliflozin.
Systemic Hypertension
Pregnant or breastfeeding women.
History of hypoglycemia.
History of recurrent urinary tract infection. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean change in abdominal girth from baseline to 12 weeks- Abdominal girth will be measured as surrogate for ascites volume.
Mean change in body weight from baseline to 12 weeks.
Mean change in the grading of ascites 
0,4,8,12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Worsening of hepatic encephalopathy
Worsening of CTP and MELD function
Frequency of other complications of cirrhosis - variceal hemorrhage or development of hepato-renal syndrome and hospitalization
Adverse effects
Mortality from complications of cirrhosis 
0,4,8,12 months 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
After obtaining written informed consent and checking for exclusion criteria, patients having cirrhosis with refractory ascites as per criteria will be enrolled in the study. Information regarding relevant history, physical examination, demographic and laboratory parameters, grade of ascites, CTP score, MELD score, LFT, RFT will be entered in a preformatted data sheet. Study subjects will be divided into three groups on the basis of the current or planned treatment regimen with monitoring for safety and adverse events for 12 weeks: Empagliflozin group- Participants will receive empagliflozin 10mg oral tablets once daily. Midodrine group- Participants will receive Midodrine 2.5mg oral tablets thrice daily. The dose might be up titrated according to the blood pressure monitoring to maximum dose 12.5 mg three times daily. Empagliflozin and Midodrine group- Participants will receive Midodrine 2.5mg oral tablets thrice daily and empagliflozin 10mg oral tablets once daily.
Once enrolled patients will be followed up at week 4, 8 and 12. Follow up data will be recorded in a pre-designed form and outcomes will be measured. Treatment of empagliflozin will be stopped if patient developed any of the following- Attack of symptomatic hypoglycemia, hypotension not responding vasopressor agent, complicated urinary tract infection or diabetic ketoacidosis). Treatment of midodrine will be stopped if SBP is 140 mmHg.
 
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