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

November 2, 2017 updated by: Institute of Liver and Biliary Sciences, India

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Delhi
      • New Delhi, Delhi, India, 110070
        • Institute of liver and Biliary Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-70 yr
  • Cirrhosis with septic shock not responding to fluid resuscitation within 2 hrs.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Noradrenaline + low dose terlipressin
Drug: Low dose terlipressin
Terlipressin-2mg (low dose )
Drug: Noradrenaline
Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min
Drug: Noradrenaline
Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min
Active Comparator: Noradrenaline
Drug: Noradrenaline
Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min
Drug: Noradrenaline
Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 28 days
28 days
Maintenance of target MAP (Mean Arterial Pressure)
Time Frame: 2 days
MAP is Mean Arterial pressure SVR is Sustained Virologic Response
2 days
Survival
Time Frame: 48 hours
48 hours
Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),
Time Frame: 2 years
2 years
Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),
Time Frame: 2 years
2 years
Effect on - AKI (Acute kidney Injury),
Time Frame: 2 years
2 years
Effect on variceal bleed
Time Frame: 2 years
2 years
Effect on rebound hypotension
Time Frame: 2 years
2 years
Effect on organ failure
Time Frame: 2 years
2 years
Length of ICU
Time Frame: 2 years
2 years
Length of hospital stay.
Time Frame: 2 years
2 years
Incidence of adverse events.
Time Frame: 2 years
2 years
Predictors of adverse events.
Time Frame: 2 years
2 years
SVR (Sustained Virologic Response) ≥600 at 48 hrs
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institute of Liver and Biliary Sciences, India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Vikash Prakash, MD, Institute of liver and Biliary Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 10, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ILBS-Cirrhosis-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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