| 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
|
|
|
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
|
|
|
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. |