Clinical trial NCT02468063: 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
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
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: 2015-06-10
Enrollment: 184
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 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


Eligibility criteria: 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

Primary outcomes:
measure: Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs
timeFrame: 6 hours
Secondary outcomes:
measure: Maintenance of target MAP (Mean Arterial Pressure)
timeFrame: 2 days
measure: Survival
timeFrame: 28 days
measure: Survival
timeFrame: 48 hours
measure: Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),
timeFrame: 2 years
measure: Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),
timeFrame: 2 years
measure: Effect on - AKI (Acute kidney Injury),
timeFrame: 2 years
measure: Effect on variceal bleed
timeFrame: 2 years
measure: Effect on rebound hypotension
timeFrame: 2 years
measure: Effect on organ failure
timeFrame: 2 years
measure: Length of ICU
timeFrame: 2 years
measure: Length of hospital stay.
timeFrame: 2 years
measure: Incidence of adverse events.
timeFrame: 2 years
measure: Predictors of adverse events.
timeFrame: 2 years
measure: SVR (Sustained Virologic Response) ≥600 at 48 hrs
timeFrame: 2 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Vikash Prakash, MD
role: PRINCIPAL_INVESTIGATOR
References: