| 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
|
|
|
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
|
|
|
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. |