Clinical trial NCT01836224: Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis With Septic Shock
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2013-04-19
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: The Hemodynamic improvement as defined as mean arterial pressure > 65 mmHg.
timeFrame: 48 hrs
Secondary outcomes:
measure: Mortality
timeFrame: Day 3, Day 7 and Day 28
measure: Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment)
timeFrame: Within 28 days
measure: Days free of vasopressors
timeFrame: Within 28 days
measure: Days free of ventilatory support
timeFrame: Within 28 days
measure: Days free of steroid
timeFrame: Within 28 dyas
measure: Length of stay
timeFrame: Within 28 days
measure: Incidence of serious adverse events.
timeFrame: Within 28 days.
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
References:
citation: Choudhury A, Kedarisetty CK, Vashishtha C, Saini D, Kumar S, Maiwall R, Sharma MK, Bhadoria AS, Kumar G, Joshi YK, Sarin SK. A randomized trial comparing terlipressin and noradrenaline in patients with cirrhosis and septic shock. Liver Int. 2017 Apr;37(4):552-561. doi: 10.1111/liv.13252. Epub 2016 Oct 20.