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

Cirrhosis With Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02468063
• Other study ID #: ILBS-Cirrhosis-001
• Status: Completed
• Phase: N/A
• First received: May 22, 2015
• Last updated: November 2, 2017
• Start date: May 1, 2015
• Est. completion date: May 31, 2017

Study information

• Verified date: January 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: May 31, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis With Septic Shock
• Fibrosis
• Liver Cirrhosis
• Shock
• Shock, Septic

Intervention

Drug:
• Low dose terlipressin
Terlipressin-2mg (low dose )
• Noradrenaline
Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min
• Noradrenaline
Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs		6 hours
Secondary	Maintenance of target MAP (Mean Arterial Pressure)	MAP is Mean Arterial pressure SVR is Sustained Virologic Response	2 days
Secondary	Survival		28 days
Secondary	Survival		48 hours
Secondary	Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),		2 years
Secondary	Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),		2 years
Secondary	Effect on - AKI (Acute kidney Injury),		2 years
Secondary	Effect on variceal bleed		2 years
Secondary	Effect on rebound hypotension		2 years
Secondary	Effect on organ failure		2 years
Secondary	Length of ICU		2 years
Secondary	Length of hospital stay.		2 years
Secondary	Incidence of adverse events.		2 years
Secondary	Predictors of adverse events.		2 years
Secondary	SVR (Sustained Virologic Response) =600 at 48 hrs		2 days