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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

NCT02468063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2017-11-06

No results posted yet for this study

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. 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

Interventions

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

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Vikash Prakash, MD · Institute of Liver and Biliary Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02468063 on ClinicalTrials.gov