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 Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Cirrhosis With Septic Shock

Intervention / Treatment
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* Drug: Low dose terlipressin
* Drug: Noradrenaline
* Drug: Noradrenaline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noradrenaline + low dose terlipressin<br> | Drug: Low dose terlipressin<br>* Terlipressin-2mg (low dose )<br>Drug: Noradrenaline<br>* Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min<br>|
| Active Comparator: Noradrenaline<br> | Drug: Noradrenaline<br>* Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance of target MAP (Mean Arterial Pressure) | MAP is Mean Arterial pressure SVR is Sustained Virologic Response | 2 days | 
| Survival |  | 28 days | 
| Survival |  | 48 hours | 
| Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference), |  | 2 years | 
| Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference), |  | 2 years | 
| Effect on - AKI (Acute kidney Injury), |  | 2 years | 
| Effect on variceal bleed |  | 2 years | 
| Effect on rebound hypotension |  | 2 years | 
| Effect on organ failure |  | 2 years | 
| Length of ICU |  | 2 years | 
| Length of hospital stay. |  | 2 years | 
| Incidence of adverse events. |  | 2 years | 
| Predictors of adverse events. |  | 2 years | 
| SVR (Sustained Virologic Response) ≥600 at 48 hrs |  | 2 days |