| CTRI Number |
CTRI/2024/09/074406 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Type of administration of drug, Continous infusion versus Intermittenmt boluses] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare and study the effects of already approved drug teripressin given by continuous infusion vs Intermittent boluses in patients with chronic liver disease induced acute kidney injury. |
|
Scientific Title of Study
|
Open labelled randomized control study on continuous intravenous infusion versus intravenous boluses of terlipressin in the management of HRS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Beeravelli Rajesh |
| Designation |
DrNB Resident |
| Affiliation |
Aster Medcity |
| Address |
Department of Medical Gastroenterology, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027
Ernakulam
KERALA
682027
India |
| Phone |
9866487222 |
| Fax |
|
| Email |
beeravelli.rajesh@asterhospital.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G N Ramesh |
| Designation |
Consultant |
| Affiliation |
Aster Medcity |
| Address |
Department of Medical Gastroenterology, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027
Ernakulam
KERALA
682027
India |
| Phone |
9847034787 |
| Fax |
|
| Email |
anjalaarth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Beeravelli Rajesh |
| Designation |
DrNB Resident |
| Affiliation |
Aster Medcity |
| Address |
Department of Medical Gastroenterology, Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027
Ernakulam
KERALA
682027
India |
| Phone |
9866487222 |
| Fax |
|
| Email |
beeravelli.rajesh@asterhospital.com |
|
|
Source of Monetary or Material Support
|
| Aster Medcity
Kuttisahib road
Cheranelloor,
South Chittoor,
Kochi,
Kerala.
India.
682027 |
|
|
Primary Sponsor
|
| Name |
Aster Medcity |
| Address |
Kuttisahib Road Cheranelloor, South Chittoor, Kochi, Kerala 682027 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Beeravelli Rajesh |
Aster Medcity |
Department of Medical Gastroenterology and Department of Hepatology, Kuttisahib Road, Cherranelloor, South chittoor, Kochi, 682027
Ernakulam
KERALA |
9866487222
beeravelli.rajesh@asterhospital.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee aster medcity |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K746||Other and unspecified cirrhosis ofliver, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Terlipressin bolus |
Terlipressin will be administered by intravenous boluses starting from 0.5mg every 6th hourly. Response to treatment will be evaluated every 48 hours. If serum creatinine does not decrease by at least 25% of the pre-treatment value, the dose of terlipressin will be progressively increased up to a maximum of dose of 2 mg every 4 hours.
The treatment with terlipressin will be continued till serum creatinine reaches a final value with in 0.3mg of patients baseline value or maximum of 14 dyas. The treatment will be discontinued in patients who develop serious side effects, exit the study midway. |
| Intervention |
Terlipressin infusion |
Terlipressin will be administered initially at a dose of 2mg/day by continuous infusion. Response to treatment will be evaluated every 48 hours. If serum creatinine dose not decrease by at least 25% of the pre-treatment value, the dose of terlipressin will be progressively increased up to a maximum of 12mg/day by 2 mg every 48 hours.
The treatment with terlipressin will be continued till serum creatinine reaches a final value with in 0.3mg of patients baseline value or maximum of 14 dyas. The treatment will be discontinued in patients who develop serious side effects, exit the study midway. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed case of cirrhosis of liver.
2. Age more than 18 years.
3. Diagnosis of hepatorenal syndrome as defined by modified criteria of internal club of ascites.
|
|
| ExclusionCriteria |
| Details |
1. Septic shock.
2. Coronary Artery Disease.
3. Hepatocellular carcinoma BCLCD
4. Post Renal AKI |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Response to treatment:
1. Complete response.
2. Partial response
3. No response |
Treatment will be continued till complete resolution of HRS AKI or Maximum of 14 days of treatment. Treatemnt will be discontinued in patients who develop serious adverse effects or exit from the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of treatment defined as prevalence of adverse events in both the groups |
Till end of treatemnt |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2024 |
| 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
|
Hepatorenal syndrome is a severe complication of cirrhosis of live that occurs characteristically in patients with ascites. Terlipressin plus albumin is the most commonly used therapeutic option for the treatment of hepatorenal syndrome. According to the peripheral arterial vasodilation hypothesis, terlipressin was introduced to counteract the splanchanic arterial vasodilation to reduce portal hypertension and to improve the reduced effective circulating volume, both thought to be pivotal factors in the pathogenesis of HRS. The effect of terlipressin on splanchnic hemodynamics, namely the reduction of portal pressure, was tested in patients with cirrhosis, it was shown that it lasted no more than 3 to 4 hours after the intravenous olus of the drug. Therefor, this cannot ensure that the drug is able to exert its positive effect on arterial splanchnic hemodynamics and continue to maintain its effect for 24 hours. Terlipressin given by continous intravenous infusion was found to be effective even when given at low dose, suggesting that it may be effective at doses lower than those required for intravenous bolus adminstration. This Randomised control trial has been designated to evaluate whether terlipressin given by continuous intravenous infusion is more suitable approach than terlipressin given by intravenous boluses in the treatment of HRS-AKI. Study hypothesis is that terlipressin given by infusion is safer, efficacious at lower doses when compared to Terlipressin given as intermittent boluses. |