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ACLF is defined differently in APASL,EASL and AASLD.APASL talks of reversibility in ACLF as per its definition and constitution of Homogenous population with ACLF.The definition of ACLF as per APASL is an acute hepatic insult manifesting as jaundice (serum bilirubin ≥ 5 mg/dL (85 micromol/L) and coagulopathy (INR ≥ 1.5 or prothrombin activity < 40%) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, and is associated with a high 28-day mortality.
At the onset of septic shock there is initially an increased secretion of Arginine vasopressin. However, this initial rise is short lasting, and the vasopressin levels come back to normal or low serum levels with continued hypotension. However, even normal levels are too low for the degree of hypotension in septic shock. This causes a relative deficiency of vasopressin in septic shock. The exact time when this fall happens is not known and it is likely to be variable. Vasopressin was therefore tried as an agent in septic shock. Terlipressin is a synthetic analogue of vasopressin. It has a greater selectivity for the V1 receptor.
Currently, Norepinephrine is recommended as the first vasopressor to be started in general in septic shock population.(3) Catecholamines are the clinically used vasopressor agents of choice for supporting arterial blood pressure and ensuring adequate organ perfusion.
Development of adrenergic hyposensitivity with loss of catecholamine presser effects is seen in advanced stages of Vasodilatory Shock. Progressively increasing catecholamine therapy frequently enters into a vicious cycle of major adverse side effects resulting in continuous clinical deterioration necessitating further catecholamine excess.
Full description
• Aim: To study the safety and efficacy of low-dose continuous infusion of terlipressin with norepinephrine compared to norepinephrine alone in improving outcomes of Acute kidney injury occurring in the context of septic shock in patients with Acute on chronic liver failure.
Study population:
septic shock with AKI in patients of ACLF
Study design: Prospective open labelled randomised controlled study. The study will be conducted in Department of Hepatology ILBS- intensive care unit.
At admission:
Complete history and physical examination
Recent Diuretics use
Loose stools / Recurrent vomiting
Monitoring • Hemodynamic- MAP,HR, Urine output hourly
• Metabolic - lactate, blood sugar, electrolytes
• Microbiologic - urine -routine, microscopy and culture, ascitic fluid analysis along with gram stain and c/s in blood culture bottle, sputum or mini BAL -C/s Gram stain. Daily.
• Others - daily chest X-ray, Procalcitonin, Cardiac-ECG, 2D echo. Prognostic models: CTP, MELD SOFA daily
Stopping Rule
• Requirement of Third Vasopressor (Need of Norepinephrine > 0.5 mcg/kg/min):
• If a patient requires norepinephrine at a dose exceeding 0.5 mcg/min, indicating the need for a third vasopressor, this criterion triggers specific actions as per the study protocol.
• Threshold (Stopping Rule) for Fluid Boluses:
• Fluid boluses will be administered based on IVC and lung ultrasound findings.
• The stopping rule for fluid boluses is activated if any of the following criteria are met:
• IVC >25
• IVCCI <40%
• B profile on lung ultrasound
• Severe Side Effects or Toxicities (CTAE Grade 4):
• If a patient experiences severe side effects or toxicities categorized as CTAE (Common Terminology Criteria for Adverse Events) Grade 4, including arrhythmia, AMI (Acute Myocardial Infarction), cardiomyopathy (as defined later), cyanosis, suspicion or confirmed bowel ischemia, or any other severe adverse event, specific actions or interventions may be required.
Salvage group • Patient Unwilling for Further Hospital Stay: • Non responders or when patient in either arm failed
• Study will be stopped and management will be done accordingly to guidelines
• Adverse effects to terlipressin
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126 participants in 2 patient groups
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Dr Jitendra Kumar Singh, MD
Data sourced from clinicaltrials.gov
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