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CTRI Number  CTRI/2021/09/036920 [Registered on: 28/09/2021] Trial Registered Prospectively
Last Modified On: 27/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the efficiency of two drugs terlipressin and noradrenaline in patients with low blood pressure and liver failure. 
Scientific Title of Study   Comparison of terlipressin infusion versus noradrenaline in septic shock in patients with acute on chronic liver failure. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tarana Gupta 
Designation  Senior professor and head Unit -6 department of general medicine pgims rohtak 
Affiliation  Pt.B.D. Sharma pgims rohtak 
Address  Office unit 3/6, department of medicine , pgims rohtak

Rohtak
HARYANA
124001
India 
Phone  9914048899  
Fax    
Email  taranagupta@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tarana Gupta 
Designation  Senior professor and head Unit -6 department of general medicine pgims rohtak 
Affiliation  Pt.B.D. Sharma pgims rohtak 
Address  Office unit 3/6, department of medicine , pgims rohtak

Rohtak
HARYANA
124001
India 
Phone  9914048899  
Fax    
Email  taranagupta@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr anjali 
Designation  Junior resident 
Affiliation  Pt. B.D. Sharma Pgims rohtak 
Address  Ward 3, department of medicine, pgims rohtak

Rohtak
HARYANA
124001
India 
Phone  9729744554  
Fax    
Email  anjali04041995@gmail.com  
 
Source of Monetary or Material Support  
Pt.B.D Sharma Pgims rohtak 
 
Primary Sponsor  
Name  Pt BD Sharma Pgims rohtak 
Address  Pgims rohtak 
Type of Sponsor  Government 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 anjali  Pt .B.D. Sharma Pgims rohtak  Department of general medicine, ward no 3,unit 6 pgims Rohtak
Rohtak
HARYANA 
9729744554

anjali04041995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical research 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 
Comparator Agent  Noradrenaline infusiom  Starting at dose of 0.1 microgram/kg/min , MAP shall be assessed every 30 min, if MAP less than 65 mm Hg infusion rate gradually increased till maximum dose of 1 microgram/kg/min. 
Intervention  Terlipressin infusion   Starting at dose of 2.6 microgram/kg/min , MAP shall be assessed every 30 minutes, if MAP less than 65mmHg , infusion rate gradually increased till maximum dose of 8.3 microgram/kg/min. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients between age 18 to 70 years.
2. Patients of Acute-on-chronic liver failure with sepsis in septic shock.
3. Patients who gives informed consent and in case patient is not in fully coherent state,consent given by first degree relative shall be taken.
 
 
ExclusionCriteria 
Details  1. Patients with any chronic respiratory disease, chronic kidney disease.
2. History of DM , hypertension.
3. History of valvular heart disease, coronary artery disease.
4. Hepatocellular carcinoma
5. Pregnant females
6. History of cerebrovascular disease 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Response of shock to therapy.  Mean arterial blood pressure I.e. MAP assessed every 30 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1 Mortality at 3,7,14 and 28 day
2. Duration of hospital stay.
3 Cumulative dose of drug.
4 other events -
a) upper gastrointestinal bleed
b) acute kidney injury
c) hepatic encephalopathy 
Mortality at 3, 7, 14 and 28 day 
 
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   N/A 
Date of First Enrollment (India)   30/09/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Liver cirrhosis is characterised by progressive fibrosis, portal hypertension and liver failure. Acute-on-Chronic liver failure is a clinical scenario wherein an acute insult leads to deterioration of underlying liver disease.The chronic liver failure (CLIF) Acute-on-Chronic liver failure (ACLF) in cirrhosis (CANONIC) study has defined ACLF in acute decompensation of cirrhosis bases upon presence and number of organ failure.Septic shock is leading cause of mortality in intensive care units in general population.Cirrhosis is a hyperdynamic circulation which worsens with infection.The choice of vasopressor for treating septic shock in ACLF patients is unclear. While noradrenaline in general is preferred vasopressor, terlipressin improves micro circulation in addition to vasopressor action.We aim to compare terlipressin infusion and noradrenaline in patients of ACLF with septic shock. It shall be a prospective, open label, randomised controlled trial. All patients of cirrhosis presenting with acute decompensation shall be screened for presence of ACLF and septic shock. All patients responsive to fluids, shall be excluded from study.After due consideration of inclusive and exclusive criteria, A total of 60 patients shall be taken , with 30 in each group.As per randomisation technique, group 1 patients shall receive noradrenaline infusion , Group 2 patients shall receive terlipressin infusion. In case of non response, alternate agent will be added after 3 hours.Patients enrolled in study will be followed for assessment of outcomes.The primary outcome shall be taken as response of shock to therapy. The secondary outcome shall be taken as mortality at 3,7,14 and 28 days, duration of hospital stay, cumulative dose of drug, recurrence of events like upper GI bleed , acute kidney injury, hepatic encephalopathy.
 
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