Cirrhosis With Septic ShockNCT02468063
To Assess the Efficacy of Early Introduction of a Combination of Low Dose Vasopressin Analogue in Addition to Noradrenaline as a Vasopressor in Patients of Cirrhosis With Septic Shock
A study testing Low dose terlipressin and Noradrenaline in people with Cirrhosis With Septic Shock, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of randomization.- The study is an open level study. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis With Septic Shock
- What is being tested?
- Low dose terlipressin and Noradrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2015to 31 May 2017
- 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
- 18-70 yr
- Cirrhosis with septic shock not responding to fluid resuscitation within 2 hrs.
Who cannot join
- ECG (ElectroCardiography)changes at presentation which exclude the use of vasopressin analouges
- Cardiac dysfunction ( valvular heart disease, coronary artery disease)
- Acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. Reynaud's syndrome or related diseases).
- Pregnancy
- Acute GI bleed
- No Consent
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: A Prospective Study to Assess the Efficacy of Early Introduction of a Combination of Low Dose Vasopressin Analogue in Addition to Noradrenaline as a Vasopressor in Patients of Cirrhosis With Septic Shock
The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of randomization.- The study is an open level study. The investigators will strictly follow the randomization table to give therapy as per the intervention arm.
- Intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and terlipressin along with noradrenaline to maintain the MAP >65mm Hg.
- Intervention arm
- Arm (A) - Noradrenaline
- Arm (B) - Noradrenaline + low dose terlipressin
- Conditions
- Cirrhosis With Septic Shock
- Being tested
- Low dose terlipressin, Noradrenaline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose terlipressinDrug
Terlipressin-2mg (low dose )
NoradrenalineDrug
Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min
NoradrenalineDrug
Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min
| Study group | Role | What they receive |
|---|---|---|
| Noradrenaline + low dose terlipressin | Experimental | Not described Receives: Drug: Low dose terlipressin; Drug: Noradrenaline |
| Noradrenaline | Active comparator | Not described Receives: Drug: Noradrenaline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs
Measured: 6 hours
Secondary outcomes (14)
Maintenance of target MAP (Mean Arterial Pressure)
MAP is Mean Arterial pressure SVR is Sustained Virologic Response
Measured: 2 days
Survival
Measured: 28 days
Survival
Measured: 48 hours
Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),
Measured: 2 years
Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),
Measured: 2 years
Effect on - AKI (Acute kidney Injury),
Measured: 2 years
Effect on variceal bleed
Measured: 2 years
Effect on rebound hypotension
Measured: 2 years
Effect on organ failure
Measured: 2 years
Length of ICU
Measured: 2 years
Length of hospital stay.
Measured: 2 years
Incidence of adverse events.
Measured: 2 years
Predictors of adverse events.
Measured: 2 years
SVR (Sustained Virologic Response) ≥600 at 48 hrs
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study start1 May 2015
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis With 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
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vikash Prakash, MD, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468063
- Sponsor's protocol ID
- ILBS-Cirrhosis-001
- Status last verified
- Jan 2017
- First submitted
- 22 May 2015
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Assess the Efficacy of Early Introduction of a Combination of Low Dose Vasopressin Analogue in Addition to Noradrenaline as a Vasopressor in Patients of Cirrhosis With Septic Shock
- ClinicalTrials.gov ID
- NCT02468063
- Acronym / sponsor ID
- ILBS-Cirrhosis-001
- Conditions
- Cirrhosis With Septic Shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 10 Jun 2015 (estimated)
- 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.
The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of randomization.- The study is an open level study. The investigators will strictly follow the randomization table to give therapy as per the intervention arm.
- Intervention:-the therapeutic intervention is vasopressor i.e. noradrenaline alone and terlipressin along with noradrenaline to maintain the MAP >65mm Hg.
- Intervention arm
- Arm (A) - Noradrenaline
- Arm (B) - Noradrenaline + low dose terlipressin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Noradrenaline + low dose terlipressin | Experimental | Drug: Low dose terlipressin, Drug: Noradrenaline |
| Noradrenaline | Active comparator | Drug: Noradrenaline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-70 yr
- Cirrhosis with septic shock not responding to fluid resuscitation within 2 hrs.
Key exclusion criteria (6 listed)
- ECG (ElectroCardiography)changes at presentation which exclude the use of vasopressin analouges
- Cardiac dysfunction ( valvular heart disease, coronary artery disease)
- Acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. Reynaud's syndrome or related diseases).
- Pregnancy
- Acute GI bleed
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 |
|---|---|---|
| Low dose terlipressinTerlipressin-2mg (low dose ) | Drug | Noradrenaline + low dose terlipressin |
| NoradrenalineNoradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min | Drug | Noradrenaline + low dose terlipressin |
| NoradrenalineNoradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min | Drug | Noradrenaline |
Primary outcome
Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs
Time frame: 6 hours
14 secondary outcomes
Maintenance of target MAP (Mean Arterial Pressure)
Time frame: 2 days
Survival
Time frame: 28 days
Survival
Time frame: 48 hours
Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),
Time frame: 2 years
Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),
Time frame: 2 years
Effect on - AKI (Acute kidney Injury),
Time frame: 2 years
Effect on variceal bleed
Time frame: 2 years
Effect on rebound hypotension
Time frame: 2 years
Effect on organ failure
Time frame: 2 years
Length of ICU
Time frame: 2 years
Length of hospital stay.
Time frame: 2 years
Incidence of adverse events.
Time frame: 2 years
Predictors of adverse events.
Time frame: 2 years
SVR (Sustained Virologic Response) ≥600 at 48 hrs
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
Related trials for Cirrhosis With Septic Shock
Active, not recruitingEarly Phase 1
Comparison of Angiotensin II to Standard Dose Vasopressors on Change in Arterial Elastance
Septic Shock, Cirrhosis
Recruiting
Echocardiography-guided Cirrhosis and Liver Failure-Intensive Care Protocol Sepsis
Cirrhosis, Liver, Cirrhotic Cardiomyopathy
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.
Vikash Prakash, MD principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose terlipressin and Noradrenaline in people with Cirrhosis With Septic Shock, 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 6 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: finished, as of the sponsor's last update on 6 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs (time frame: 6 hours). 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 6 Nov 2017.