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

Information source: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cirrhosis With Septic Shock.

Intervention: Terlipressin (Drug); Noradrenaline (Drug)

Phase: N/A

Status: Completed

Sponsored by: Institute of Liver and Biliary Sciences, India


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.

Clinical Details

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.

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

Primary outcome: The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg.

Secondary outcome:


Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment)

Days free of vasopressors

Days free of ventilatory support

Days free of steroid

Length of stay

Incidence of serious adverse events.


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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)

Locations and Contacts

Institute of liver and Biliary Sciences, New Delhi, Delhi 110070, India
Additional Information

Starting date: October 2012
Last updated: May 23, 2015

Page last updated: August 23, 2015

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