Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit

Cirrhosis With Septic Shock Clinical Trial

Official title:

A Prospective Open Label Randomized Non Inferiority Trial to Compare the Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836224
• Other study ID #: ILBS-Sepsis-01
• Status: Completed
• Phase: N/A
• First received: April 2, 2013
• Last updated: November 21, 2016
• Start date: October 2012
• Est. completion date: September 2014

Study information

• Verified date: December 2013
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The Patient evaluated in Emergency room since admission and detailed history and clinical examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive Care Unit (ICU) in view of septic shock were included since onset of shock.

Initial fluid resuscitation done and if the patient were no fluid responsive they were randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the primary objectives. At the same time the strict vitals monitoring and standard medical therapy for sepsis including antibiotics and other supportive therapy continued. The patients were followed up till discharge, death or up to 28days after enrollment into the protocol (whichever the longest). The detail methodology has been explained in column 14 later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patient of cirrhosis or ACLF (Acute on Chronic Liver Failure) with septic shock (defined later).

• Age 18-70yrs

• An informed consent from the patient or relative

Exclusion Criteria:

• Pronounced 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

• Previous history of transplantation on immunosuppressant.

• Acute gastrointestinal bleed.(defined later)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Terlipressin
Terlipressin (1.3mcg/min i.e 2mg over 24 hr to max of terlipressin 5.2mcg/min i.e. up to 8mg over 24hr) .The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure) >65 .Terlipressin 2mg in 48ml,1ml=42mcg=0.67mg/min, max dose 8mg/day- 8ml/hr of infusion.
• Noradrenaline
Noradrenaline 2amp (4000mcg in 50ml) at 6ml/hr = 7.5mcg/min and dose maximum 60mcg/min 24ml/hr double strength. The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure)>65

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	The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg.		48 hrs	Yes
Secondary	Mortality		Day 3, Day 7 and Day 28	Yes
Secondary	Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment)		Within 28 days	No
Secondary	Days free of vasopressors		Within 28 days	No
Secondary	Days free of ventilatory support		Within 28 days	Yes
Secondary	Days free of steroid		Within 28 dyas	No
Secondary	Length of stay		Within 28 days	No
Secondary	Incidence of serious adverse events.		Within 28 days.	Yes