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CTRI Number  CTRI/2024/05/067631 [Registered on: 20/05/2024] Trial Registered Prospectively
Last Modified On: 18/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Randomized controlled trial comparing the efficacy of Furosemide vs Torsemide in cirrhotic patients with newly diagnosed ascites  
Scientific Title of Study   A Prospective randomized controlled Open labelled two arm pilot study with blinded endpoints (PROBE) to evaluate the effect of Torsemide spironolactone vs Furosemide spironolactone combination in cirrhotic patients with newly diagnosed 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 Arun Valsan 
Designation  Clinical Assisstant Professor 
Affiliation  Amrita Institute of Medical Sciences and research Centre, Kochi 
Address  Hepatology Department Room number 5 A block first tower first floor Amrita Institute of Medical Sciences and Research center Kochi

Ernakulam
KERALA
682041
India 
Phone  8411051156  
Fax    
Email  drarunvalsan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Narmada MP 
Designation  HOD Pharmacy Practice Department  
Affiliation  Amrita School of Pharmacy 
Address  HOD Department of Pharmacy Practice Third tower sixth floor Amrita Institute of Medical Sciences and Research center Kochi

Ernakulam
KERALA
682041
India 
Phone  8411051156  
Fax    
Email  narmadha@pharmacy.aims.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dr Arun Valsan 
Designation  Clinical Assisstant Professor 
Affiliation  Amrita Institute of Medical Sciences and research Centre, Kochi 
Address  Hepatology department Room no 5 A block First tower first floor Amrita Institute of Medical Sciences and Research center Kochi

Ernakulam
KERALA
682041
India 
Phone  8411051156  
Fax    
Email  drarunvalsan@gmail.com  
 
Source of Monetary or Material Support  
Amrita School of Medicine, Amrita Institute of Medical Sciences and Research center, Ponekkara P O, Edapally, Kochi Kerala, India Pincode 682041 
 
Primary Sponsor  
Name  Amrita school of Medicine 
Address  Amrita School of Medicine, Amrita Institute of Medical Sciences, Ponekkara P.O. , Kochi, Kerala, India, Pin code 682041 
Type of Sponsor  Private medical college 
 
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 Arun Valsan  Amrita Institute of Medical sciences and Reserch centre, Kochi  Hepatology department room number 5 first floor first tower Amrita Institute of Medical Sciences and Research center Ponekkara PO Edappally Kochi
Ernakulam
KERALA 		 8411051156

drarunvalsan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics committee, AIMS PO Kochi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K74||Fibrosis and cirrhosis of liver,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Furosemide and Spironolactone  Furosemide 20mg and Spironolactone 50mg once daily dosing in the morning for 28 days 
Intervention  Torsemide and Spironolactone  Torsemide 10mg and Spironolactone 50mg once daily dosing in the morning for 28 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Cirrhosis diagnosed by imaging and or biopsy with newly diagnosed ascites with Ascitic fluid Protein less than 2.5g per dL, SAAG more than 1.1
2 Cirrhosis as evidenced by USG or Cross-Sectional imaging
3 Serum Creatinine less than 1.5mg per dl
4 Informed consent
 
 
ExclusionCriteria 
Details  1 Spontaneous bacterial peritonitis
2 Pregnancy
3 Serum Creatinine more than 1.5 mg per dl
4. Urine albumin is to Creatinine ratio more than 500mg per gm creatinine
5 Poorly controlled diabetes, fasting glucose more than 200mg per dl
6.SIADH, as per Bartter Schwartz criteria
7.Anuria, urine volume less than 100ml per day
8.Cerebrovascular accident within 30 days prior to the study medication.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Efficacy to control ascites in patients with cirrhosis using the mean change in body weight and need for large volume paracentesis  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the therapeutic drug monitoring of both drugs
2.To study the treatment emergent complications of therapy
a.Dyselectrolytemia (Na+, K+, Mg ++, Ca++)
b.Change in urinary Na+, K+
c.Acute kidney Injury defined by KDIGO criteria( Kidney disease improving global outcome) and Need for renal replacement therapy
d.Muscle cramps using Cramps questionnaire {1}
e.Hepatic Encephalopathy by West Haven Criteria
f.Need for dose escalation
g.Mean arterial pressure
h.28-day survival
3.To evaluate the Quality of Life of patients using WHO HQOL bref (World health organization quality of life brief version){2}
4.To assess the incremental cost-effectiveness ratio
 		 28 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 4 
Date of First Enrollment (India)   29/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

All the cirrhotic patients with newly diagnosed ascites presenting to Hepatology and Gastroenterology department f Amrita hospital will be screened. Those who fulfill the inclusion criteria of the study will be invited to participate in the study. A detailed consent form will be provided and after obtaining consent from patient they will be enrolled into either the control arm recieving Furosemide 20mg+ spironolactone 50mg or the study arm recieving Torsemide 10mg+ Spironolactone 50mg. As per the pre prepared computer generated randomisation sequence in the ratio 1:1. All enrolled patients will be given medications for 28days. Patients will be taught how to measure abdominal girth and body weight. 5g premeasured salt will be given to the patients. After 4 days of diuretic therapy the following will be determined. Urine Na+/K+, abdominal girth, body weight, RFT, Serum electrolytes. 

If Urine Na+/K+ >1, 2 kg body weight loss occurs - Diuretic sensitive, and SRD fllowed

If Urine Na+/K+>1, less than 2 kg weight loss occurs - Diuretic Sensitive and SRD sensitive

If Urine Na+/K+<1 - Diuretic dose resistsnt, dose escalation required


The dose escalation according to the ascitic control determined by body weight and USG imaging will be left to clinicians discretion. The study drugs will be administered once daily for 28days and followup will be done on every 4th day. The TDM of both drugs will be assessed.  

 
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