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

NCT ID: NCT04522297

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2020-01-23

Brief Summary

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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.

Detailed Description

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Conditions

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Hepato-Renal Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Midodrine/Octreotide

oral midodrine plus octreotide as subcutaneous injection

Group Type EXPERIMENTAL

Midodrine/Octreotide

Intervention Type DRUG

oral midodrine plus octreotide as subcutaneous injection

Nor-epinephrine

Intravenous infusion norepinephrine

Group Type ACTIVE_COMPARATOR

Nor-epinephrine

Intervention Type DRUG

Intravenous infusion norepinephrine

Interventions

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Midodrine/Octreotide

oral midodrine plus octreotide as subcutaneous injection

Intervention Type DRUG

Nor-epinephrine

Intravenous infusion norepinephrine

Intervention Type DRUG

Other Intervention Names

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albumin at doses of 20 to 40 g/day albumin at doses of 20 to 40 g/day

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Hepatology & Tropical Medicine Research Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Doaa abdelaziz

Lecturer of clinical pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Doaa Abdelaziz yousef, Ph.D

Role: STUDY_DIRECTOR

Fellow at The National Hepatology and Tropical Research medicine institute

Locations

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The National Hepatology and Tropical Research medicine institute

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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02-2018

Identifier Type: -

Identifier Source: org_study_id

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