NCT02468063

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

November 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2.1 years

First QC Date

May 22, 2015

Last Update Submit

November 2, 2017

Conditions

Cirrhosis With Septic Shock

Outcome Measures

Primary Outcomes (1)

  • Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs

    6 hours

Secondary Outcomes (14)

  • Maintenance of target MAP (Mean Arterial Pressure)

    2 days

  • Survival

    28 days

  • Survival

    48 hours

  • Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),

    2 years

  • Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),

    2 years

  • +9 more secondary outcomes

Study Arms (2)

Noradrenaline + low dose terlipressin

EXPERIMENTAL
Drug: Low dose terlipressinDrug: Noradrenaline

Noradrenaline

ACTIVE COMPARATOR
Drug: Noradrenaline

Interventions

Low dose terlipressinDRUG

Terlipressin-2mg (low dose )

Noradrenaline + low dose terlipressin
NoradrenalineDRUG

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

Noradrenaline + low dose terlipressin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cirrhosis with septic shock not responding to fluid resuscitation within 2 hrs.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Interventions

TerlipressinNorepinephrine

Intervention Hierarchy (Ancestors)

LypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteinsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Vikash Prakash, MD

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2015

First Posted

June 10, 2015

Study Start

May 1, 2015

Primary Completion

May 31, 2017

Study Completion

May 31, 2017

Last Updated

November 6, 2017

Record last verified: 2017-01

Locations

IN(1)