Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Syndrome

National Hepatology & Tropical Medicine Research Institute

Status: Completed

Conditions: Hepato-Renal Syndrome

Treatments: Drug: Midodrine/Octreotide; Drug: Nor-epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04522297

02-2018

Details and patient eligibility

About

Hepatorenal syndrome is a functional renal impairment occurring in cirrhotic patients . It develops secondary to splanchnic arterial vasodilatation which decreases the effective blood volume, activate the renin-angiotensin-aldosterone system, and stimulate of sympathetic nervous system.This study aims to compare the efficacy of nor-epinephrine versus midodrine/ octreotide, together with intravenous albumin on renal functions of patients with hepatorenal acute kidney injury.

Enrollment: 91 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Both sexes aged 18 years or older having cirrhosis, ascites, and a diagnosis of HRS-AKI based on the 2015 International Club of Ascites (ICA) diagnostic criteria

Exclusion criteria

Serum creatinine (sCr) >7 mg/dL Hypotension (mean arterial pressure (MAP) <70 mm Hg) or sepsis. Recent treatment with vasopressors. Patients with severe cardiovascular disease Known allergy to study medications

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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91 participants in 2 patient groups

Midodrine/Octreotide

Experimental group

Description:

oral midodrine plus octreotide as subcutaneous injection

Treatment:

Drug: Midodrine/Octreotide

Nor-epinephrine

Active Comparator group

Description:

Intravenous infusion norepinephrine

Treatment:

Drug: Nor-epinephrine