Comparison of Bolus Versus Continuous Infusion of Terlipressin Cirrhotic Patients With Septic Shock.

• Status: Recruiting
• Trial end date: 2022-03-19
• Target enrollment: 0
• Participant gender: All

Summary

Septic shock is a major life-threatening vasodilatory shock. Vasopressor form a crucial pharmacotherapeutic option and have long been used as the first and foremost recommended therapy.(1) However, some patients may remain refractory to catecholamine, which is also known as catecholamine-resistant septic shock.(2, 3) High-dose catecholamine therapy may lead to potential side effects such as increased myocardial oxygen consumption, lethal arrthymias, and even the high risk of mortality. (4)Therefore, newer alternatives like dopamine, dobutamine, somatostatin, and terlipressin are also used.

Cirrhosis is a state of hyperdynamic circulation, which worsens with the onset of infection. In septic shock, there is relative deficiency of vasopressin. (13) The mortality of septic shock in these patients still remains extremely high. Terlipressin is a synthetic vasopressin analogue with greater selectivity for the V1-receptors.(5) In cirrhotics with septic shock, terlipressin has been used either as a continuous intravenous infusion or as intravenous boluses. However, at present none of studies reveal which would be a better mode of administration in cirrhotics with septic shock considering the reversal of hemodynamics and safety of patients.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Liver and Biliary Sciences, India
• Treatments: Terlipressin

Criteria

Inclusion Criteria:

• Cirrhotics including ACLF with septic shock requiring norepinephrine dose >0.5ug/kg/min to maintain MAP> 65 mm Hg

• An informed consent from the patient or relative

Exclusion Criteria:

• Patients with age less than 18 years or more than 65 years

• Severe known cardiopulmonary disease (Hypertension, structural or valvular heart disease, coronary artery disease, arrhythmias)

• Stroke

• Peripheral Vascular disease

• Gut Paralysis

• Intestinal obstruction

• Cancer, hepato-cellular carcinoma (HCC), intrahepatic or extrahepatic malignancy

• Portal vein thrombosis

• Hepatic vein outflow tract obstruction (HVOTO )

• Pregnancy

• Patients with Pa02/FiO2 ratio <150

• Severe coagulopathy platelets <20,000 and INR > 4

• Active Bleed (Mucosal or variceal)

• Patients already on terlipressin in the last 48 hours

• Extremely moribund patients with an expected life expectancy of less than 24 hours

• Failure to give informed consent from family members.

• Patient enrolled in other clinical trials