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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

NCT ID: NCT02468063

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2017-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Cirrhosis With Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Noradrenaline + low dose terlipressin

Group Type EXPERIMENTAL

Low dose terlipressin

Intervention Type DRUG

Terlipressin-2mg (low dose )

Noradrenaline

Intervention Type DRUG

Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min

Noradrenaline

Group Type ACTIVE_COMPARATOR

Noradrenaline

Intervention Type DRUG

Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min

Interventions

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Low dose terlipressin

Terlipressin-2mg (low dose )

Intervention Type DRUG

Noradrenaline

Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min

Intervention Type DRUG

Noradrenaline

Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vikash Prakash, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Liver and Biliary Sciences

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-Cirrhosis-001

Identifier Type: -

Identifier Source: org_study_id