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 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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02468063

Enrollment

184

Registered

2015-06-10

Start date

2015-05-01

Completion date

2017-05-31

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis With Septic Shock

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

Interventions

DRUGLow dose terlipressin

Terlipressin-2mg (low dose )

DRUGNoradrenaline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs	6 hours

Secondary

Measure	Time frame	Description
Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),	2 years	—
Maintenance of target MAP (Mean Arterial Pressure)	2 days	MAP is Mean Arterial pressure SVR is Sustained Virologic Response
Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),	2 years	—
Effect on - AKI (Acute kidney Injury),	2 years	—
Effect on variceal bleed	2 years	—
Effect on rebound hypotension	2 years	—
Survival	28 days	—
Length of ICU	2 years	—
Length of hospital stay.	2 years	—
Incidence of adverse events.	2 years	—
Predictors of adverse events.	2 years	—
SVR (Sustained Virologic Response) ≥600 at 48 hrs	2 days	—
Effect on organ failure	2 years	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026