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

Not Applicable

Completed

• Conditions: Cirrhosis With Septic Shock
• Interventions: Drug: Noradrenaline; Drug: Terlipressin

• Registration Number: NCT01836224
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-04-02
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-19
• Status Verified: 2013-12
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Last Update Submitted: 2016-11-21
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Noradrenaline	Noradrenaline	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.
Terlipressin	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.

Primary Outcome Measures

Name	Time	Method
The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg.	48 hrs

Secondary Outcome Measures

Name	Time	Method
Mortality	Day 3, Day 7 and Day 28
Length of stay	Within 28 days
Days free of vasopressors	Within 28 days
Days free of steroid	Within 28 dyas
Incidence of serious adverse events.	Within 28 days.
Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment)	Within 28 days
Days free of ventilatory support	Within 28 days

Trial Locations

Locations (1)

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