Septic ShockNCT05315557
Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial
A study testing Terlipressin and vasopressin in people with Septic Shock and Cirrhosis, Liver, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
Sepsis is a life-threatening organ dysfunction caused by dysregulated host response. A Subset of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis. Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Septic Shock, Cirrhosis, Liver
- What is being tested?
- Terlipressin and vasopressin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 5 Apr 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70yrs
- An informed consent from the patient or relative
Who cannot join
- Age <18 years and > 70 years
- Stroke
- Severe sepsis requiring higher dose of noradrenaline (>1mcg/Kg/min)
- Myocardial dysfunction, Coronary artery disease, Arrhythmias
- Peripheral Vascular disease
- Gut Paralysis
Show all 20Show fewer
- Acute on chronic liver failure (ACLF)
- Hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy
- Complete portal vein thrombosis
- Hepatic vein outflow tract obstruction (HVOTO)
- Pregnancy
- Patients with Pa02/FiO2 ratio <150
- CKD
- COPD
- Severe coagulopathy - platelets <20,000 and INR > 4
- Active Bleed or DIC
- Patients already on terlipressin or vasopressin in the last 48 hours
- Extremely moribund patients with an expected life expectancy of less than 24 hours
- Failure to give informed consent from family members.
- Patient enrolled in other clinical trial
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Vishnu Girish, MD, 01146300000, vishnugirish@gmail.com
About this study
Official title: Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial.
Sepsis is a life-threatening organ dysfunction caused by dysregulated host response. A Subset of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis. Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory dysfunction. The circulatory dysfunction in sepsis is in the form of severe vasodilatation with high cardiac index. Cirrhosis is a state of hyperdynamic circulation. The mortality of septic shock in these group of patients is still higher.
At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor. Terlipressin is also shown to be effective in septic shock in cirrhotics3. Other vasoactive agents are not preferred in cirrhotics - dopamine due to high risk of arrhythmias and dobutamine as baseline cardiac output of cirrhotics is high which further increases in sepsis and dobutamine would further add to it. However, it may be given in myocardial dysfunction. Noradrenaline is recommended as the first vasopressor to be started in general in septic shock population. No study has compared the effectiveness of vasopressin and Terlipressin when added to noradrenaline in patients with cirrhosis. Acute kidney injury is a very common complication of septic shock in cirrhotics.
Read the detailed description
Hypothesis: We hypothesise that vasopressin would be non-inferior to terlipressin as a second vasopressor in critically ill cirrhotics with septic shock and would have lesser adverse effects when compared to terlipressin.
Aim: To compare the efficacy of adding continuous infusion of terlipressin versus vasopressin to noradrenaline in causing improvement in systemic hemodynamics and microcirculation.
Methodology:
Study population:
- Critically ill cirrhotic - Defined as a cirrhotic patient who presents with at least one organ failure, defined by SOFA score WITH
- septic shock - Defined as a patient in septic shock after initial fluid resuscitation and antibiotic administration, requiring a noradrenaline of at least 2.6mcg/min to maintain a MAP more than 65mmHg.
Study design: Prospective open label randomised controlled study. The study will be conducted in Department of Hepatology ILBS- intensive care unit.
Study period: 1 year
Sample size: Based on the previous studies it is assumed that terlipressin + noradrenaline group would give a response rate of 93%, it was assumed that vasopressin and noradrenaline would give a response rate 15% less than the terlipressin and noradrenaline group and a response rate of 78% was assumed. Further considering an alpha error of 5% and power 95% with a non-inferiority margin of 10% we need to enroll 82 cases Assuming a 10% dropout rate we need to enroll 90 cases with 45 in each arm. However, we decided to enroll 100 cases randomized into 2 groups, 50 each by block randomization method by taking a block size of 10
Patients will be evaluated in the Emergency Room. Detailed history and clinical examination and investigation accordingly will be sent when septic shock is clinically suspected
Fluid Resuscitation Initially a 16G peripheral line will be placed. CVP line and arterial line preferably in the radial artery will be placed as soon as possible.
5% albumin will be used as the resuscitation fluids according to the FRISC protocol.
Fluid response will be assessed at the end of 1 hour
Antibiotics Antibiotics will be given according to the institutional policy
Vasopressors Noradrenaline will be started at a dose of 0.05mcg/kg/min and titrated. All the infusions will be given via central line placed in the jugular, subclavian or femoral vein by a critical care expert under USG guidance.
Intervention:Patients after screening for all exclusion criteria will be randomised into 2 arms (group-1, Terlipressin arm) and (group-2, Vasopressin arm) in a ratio 1:1
- STATISTICAL ANALYSIS: Continuous data- Student's t test
- Nonparametric analysis- Mann Whitney test
- Survival outcome By Kaplan-Meier method curve.
- For all tests, p≤ 0.05 will be considered statistically significant.
- Analysis will be performed using SPSS.
- The analysis will be done with intention to treat and per protocol analysis if applicable.
Stopping rule: Side effects or toxicities that are severe -arrhythmia, AMI, Cardiomyopathy (defined later) Cyanosis.
- Suspicion or confirmed bowel ischemia.
- Patient unwilling for further hospital stay.
- Study unrelated complication here the drug effects could not be assessed (massive
- GI bleed uncontrolled, bowel perforation or any surgical intervention).
- Conditions
- Septic Shock, Cirrhosis, Liver
- Being tested
- Terlipressin, vasopressin
- Medical subject headings
- Shock, Septic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerlipressinDrug
1mg/24 hour and titrate according to MAP
vasopressinDrug
0.03 U/hour and titrate according to MAP
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin | Experimental | Terlipressin 1mg/24 hours Receives: Drug: Terlipressin |
| Vasopressin | Active comparator | Vasopressin 0.03 U/hour Receives: Drug: vasopressin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in systemic hemodynamics at 6 hours after randomization
Improvement in systemic hemodynamics defined as discontinuation of noradrenaline infusion OR reversal of shock
Measured: 6 hours after randomization
Secondary outcomes (30)
Reduction in dose of noradrenaline at the end of 6 hours
Measured: 6 hours
Amount of noradrenaline requirements between in each arm at the end of 6 hours
Measured: 6 hours
Improvement in Systemic Vascular Resistance (SVR) by 10% or above 500 at 6 hours
Systemic Vascular Resistance will be measured by using pulmonary thermodilution
Measured: 6 hours
Improvement in SVR by 10% or above 500 at 12 hours
Measured: 12 hours
Improvement in SVR by 10% or above 500 at 48 hours
Measured: 48 hours
Decrease in Cardiac output by 10% or less than 6L after 6 hours of randomization
Cardiac output will be measured by using pulmonary thermodilution
Measured: 6 hour of randomization
KDIGO criteria - increase in urine output in 6 hours
Measured: 6 hour
KDIGO criteria - increase in urine output in 12 hours.
Measured: 12 hour
KDIGO criteria - increase in urine output in 24 hours
Measured: 24 hour
KDIGO criteria - increase in urine output in 48 hours.
Measured: 48 hour
improvement in serum creatinine in 24 (Improvement in KDIGO stage at 24)
Measured: 24 hour
Improvement in serum creatinine in 48 hours (Improvement in KDIGO stage at 48 hours)
Measured: 48 hour
Need of Renal Replacement Therapy
Measured: Day 28
Improvement in microcirculation as measured by improvement in lactate
Measured: 6 hours
Improvement in microcirculation as measured by improvement in capillary refill time at 6 hours
Measured: 6 hours
Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible
Measured: 6 hours
Improvement in microcirculation as measured by improvement in lactate
Measured: 24 hours
Improvement in microcirculation as measured by improvement in capillary refill time at 24 hours.
Measured: 24 hours
Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible
Measured: 24 hours
Improvement in microcirculation as measured by improvement in lactate
Measured: 48 hours
Improvement in microcirculation as measured by improvement in capillary refill time at 48 hours.
Measured: 48 hours
Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible
Measured: 48 hours
Improvement in renal resistive index at 24 hours
Measured: 24 hours
Improvement in renal resistive index at 48 hours
Measured: 48 hours
Incidence of adverse effects till 48 hours after randomization including incidence of rebound hypertension
Measured: 48 hours
Mortality at day 28
Measured: Day 28
Days of mechanical ventilation
Measured: Day 28
Days of Intensive Care Unit stay.
Measured: Day 28
Endothelial function will be measured in a subset of patients
Endothelial function will be assessed from a change in endothelin-1 and von Willebrand Factor (vWF) levels in a subset of patients whereever feasible
Measured: 48 hours
Coagulation function will measure in a subset of patients
Coagulation function will be measured by change in rotational thromboelastometry test
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start5 Apr 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315557
- Sponsor's protocol ID
- ILBS-Cirrhosis-48
- Status last verified
- Mar 2022
- First submitted
- 7 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial.
- ClinicalTrials.gov ID
- NCT05315557
- Acronym / sponsor ID
- ILBS-Cirrhosis-48
- Conditions
- Septic Shock, Cirrhosis, Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 5 Apr 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis is a life-threatening organ dysfunction caused by dysregulated host response. A Subset of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis. Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory dysfunction. The circulatory dysfunction in sepsis is in the form of severe vasodilatation with high cardiac index. Cirrhosis is a state of hyperdynamic circulation. The mortality of septic shock in these group of patients is still higher.
At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor. Terlipressin is also shown to be effective in septic shock in cirrhotics3. Other vasoactive agents are not preferred in cirrhotics - dopamine due to high risk of arrhythmias and dobutamine as baseline cardiac output of cirrhotics is high which further increases in sepsis and dobutamine would further add to it. However, it may be given in myocardial dysfunction. Noradrenaline is recommended as the first vasopressor to be started in general in septic shock population. No study has compared the effectiveness of vasopressin and Terlipressin when added to noradrenaline in patients with cirrhosis. Acute kidney injury is a very common complication of septic shock in cirrhotics.
Detailed description
Hypothesis: We hypothesise that vasopressin would be non-inferior to terlipressin as a second vasopressor in critically ill cirrhotics with septic shock and would have lesser adverse effects when compared to terlipressin.
Aim: To compare the efficacy of adding continuous infusion of terlipressin versus vasopressin to noradrenaline in causing improvement in systemic hemodynamics and microcirculation.
Methodology:
Study population:
- Critically ill cirrhotic - Defined as a cirrhotic patient who presents with at least one organ failure, defined by SOFA score WITH
- septic shock - Defined as a patient in septic shock after initial fluid resuscitation and antibiotic administration, requiring a noradrenaline of at least 2.6mcg/min to maintain a MAP more than 65mmHg.
Study design: Prospective open label randomised controlled study. The study will be conducted in Department of Hepatology ILBS- intensive care unit.
Study period: 1 year
Sample size: Based on the previous studies it is assumed that terlipressin + noradrenaline group would give a response rate of 93%, it was assumed that vasopressin and noradrenaline would give a response rate 15% less than the terlipressin and noradrenaline group and a response rate of 78% was assumed. Further considering an alpha error of 5% and power 95% with a non-inferiority margin of 10% we need to enroll 82 cases Assuming a 10% dropout rate we need to enroll 90 cases with 45 in each arm. However, we decided to enroll 100 cases randomized into 2 groups, 50 each by block randomization method by taking a block size of 10
Patients will be evaluated in the Emergency Room. Detailed history and clinical examination and investigation accordingly will be sent when septic shock is clinically suspected
Fluid Resuscitation Initially a 16G peripheral line will be placed. CVP line and arterial line preferably in the radial artery will be placed as soon as possible.
5% albumin will be used as the resuscitation fluids according to the FRISC protocol.
Fluid response will be assessed at the end of 1 hour
Antibiotics Antibiotics will be given according to the institutional policy
Vasopressors Noradrenaline will be started at a dose of 0.05mcg/kg/min and titrated. All the infusions will be given via central line placed in the jugular, subclavian or femoral vein by a critical care expert under USG guidance.
Intervention:Patients after screening for all exclusion criteria will be randomised into 2 arms (group-1, Terlipressin arm) and (group-2, Vasopressin arm) in a ratio 1:1
- STATISTICAL ANALYSIS: Continuous data- Student's t test
- Nonparametric analysis- Mann Whitney test
- Survival outcome By Kaplan-Meier method curve.
- For all tests, p≤ 0.05 will be considered statistically significant.
- Analysis will be performed using SPSS.
- The analysis will be done with intention to treat and per protocol analysis if applicable.
Stopping rule: Side effects or toxicities that are severe -arrhythmia, AMI, Cardiomyopathy (defined later) Cyanosis.
- Suspicion or confirmed bowel ischemia.
- Patient unwilling for further hospital stay.
- Study unrelated complication here the drug effects could not be assessed (massive
- GI bleed uncontrolled, bowel perforation or any surgical intervention).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Terlipressin | Experimental | Drug: TerlipressinTerlipressin 1mg/24 hours |
| Vasopressin | Active comparator | Drug: vasopressinVasopressin 0.03 U/hour |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-70yrs
- An informed consent from the patient or relative
Key exclusion criteria (20 listed)
- Age <18 years and > 70 years
- Stroke
- Severe sepsis requiring higher dose of noradrenaline (>1mcg/Kg/min)
- Myocardial dysfunction, Coronary artery disease, Arrhythmias
- Peripheral Vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Terlipressin1mg/24 hour and titrate according to MAP | Drug | Terlipressin |
| vasopressin0.03 U/hour and titrate according to MAP | Drug | Vasopressin |
Primary outcome
Improvement in systemic hemodynamics at 6 hours after randomization
Time frame: 6 hours after randomization
Improvement in systemic hemodynamics defined as discontinuation of noradrenaline infusion OR reversal of shock
30 secondary outcomes
Reduction in dose of noradrenaline at the end of 6 hours
Time frame: 6 hours
Amount of noradrenaline requirements between in each arm at the end of 6 hours
Time frame: 6 hours
Improvement in Systemic Vascular Resistance (SVR) by 10% or above 500 at 6 hours
Time frame: 6 hours
Improvement in SVR by 10% or above 500 at 12 hours
Time frame: 12 hours
Improvement in SVR by 10% or above 500 at 48 hours
Time frame: 48 hours
Decrease in Cardiac output by 10% or less than 6L after 6 hours of randomization
Time frame: 6 hour of randomization
KDIGO criteria - increase in urine output in 6 hours
Time frame: 6 hour
KDIGO criteria - increase in urine output in 12 hours.
Time frame: 12 hour
KDIGO criteria - increase in urine output in 24 hours
Time frame: 24 hour
KDIGO criteria - increase in urine output in 48 hours.
Time frame: 48 hour
improvement in serum creatinine in 24 (Improvement in KDIGO stage at 24)
Time frame: 24 hour
Improvement in serum creatinine in 48 hours (Improvement in KDIGO stage at 48 hours)
Time frame: 48 hour
Need of Renal Replacement Therapy
Time frame: Day 28
Improvement in microcirculation as measured by improvement in lactate
Time frame: 6 hours
Improvement in microcirculation as measured by improvement in capillary refill time at 6 hours
Time frame: 6 hours
Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible
Time frame: 6 hours
Improvement in microcirculation as measured by improvement in lactate
Time frame: 24 hours
Improvement in microcirculation as measured by improvement in capillary refill time at 24 hours.
Time frame: 24 hours
Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible
Time frame: 24 hours
Improvement in microcirculation as measured by improvement in lactate
Time frame: 48 hours
Improvement in microcirculation as measured by improvement in capillary refill time at 48 hours.
Time frame: 48 hours
Improvement in microcirculation as measured by Near IR spectroscopy ina subset of patients whenever feasible
Time frame: 48 hours
Improvement in renal resistive index at 24 hours
Time frame: 24 hours
Improvement in renal resistive index at 48 hours
Time frame: 48 hours
Incidence of adverse effects till 48 hours after randomization including incidence of rebound hypertension
Time frame: 48 hours
Mortality at day 28
Time frame: Day 28
Days of mechanical ventilation
Time frame: Day 28
Days of Intensive Care Unit stay.
Time frame: Day 28
Endothelial function will be measured in a subset of patients
Time frame: 48 hours
Coagulation function will measure in a subset of patients
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Terlipressin and vasopressin in people with Septic Shock and Cirrhosis, Liver, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Vishnu Girish, MD (01146300000, vishnugirish@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in systemic hemodynamics at 6 hours after randomization (time frame: 6 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.