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

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

Study Overview

• Status: Completed
• Conditions: Cirrhosis With Septic Shock
• Intervention / Treatment: Drug: Low dose terlipressin; Drug: Noradrenaline; Drug: Noradrenaline

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of liver and Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Noradrenaline + low dose terlipressin	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
Active Comparator: Noradrenaline	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival		28 days
Maintenance of target MAP (Mean Arterial Pressure)	MAP is Mean Arterial pressure SVR is Sustained Virologic Response	2 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
Effect on - AKI (Acute kidney Injury),		2 years
Effect on variceal bleed		2 years
Effect on rebound hypotension		2 years
Effect on organ failure		2 years
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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Vikash Prakash, MD, Institute of liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2015
• Primary Completion (Actual): May 31, 2017
• Study Completion (Actual): May 31, 2017

Study Registration Dates

• First Submitted: May 22, 2015
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Liver Diseases; Sepsis; Fibrosis; Shock, Septic; Shock; Liver Cirrhosis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Norepinephrine; Terlipressin
• Other Study ID Numbers: ILBS-Cirrhosis-001