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

Not Applicable

Completed

• Conditions: Cirrhosis With Septic Shock
• Interventions: Drug: Low dose terlipressin; Drug: Noradrenaline

• Registration Number: NCT02468063
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-01
• Study First Submitted: 2015-05-22
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Status Verified: 2017-01
• Primary Completion: 2017-05-31
• Study Completion: 2017-05-31
• Last Update Submitted: 2017-11-02
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noradrenaline + low dose terlipressin	Low dose terlipressin	-
Noradrenaline + low dose terlipressin	Noradrenaline	-
Noradrenaline	Noradrenaline	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institute of Liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India