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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Noradrenaline + low dose terlipressin | Experimental |
| |
| Noradrenaline | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose terlipressin | Drug | Terlipressin-2mg (low dose ) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs | 6 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vikash Prakash, MD | Institute of Liver and Biliary Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| Noradrenaline |
| Drug |
Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min |
|
| Noradrenaline | Drug | Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min |
|
| 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 |
| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| D009638 | Norepinephrine |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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