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Completed

NCT Number: NCT04522297

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

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.

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Key information

Conditions

Hepato-Renal Syndrome Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hepatorenal Syndrome Kidney Diseases Liver Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The National Hepatology and Tropical Research medicine institute

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midodrine/Octreotide

Drug

oral midodrine plus octreotide as subcutaneous injection

Other names: albumin at doses of 20 to 40 g/day

Nor-epinephrine

Drug

Intravenous infusion norepinephrine

Other names: albumin at doses of 20 to 40 g/day

Primary outcomes

  1. Full response

    Time frame: 10 days

    the proportion of patients achieved full response defined as return of serum creatinine to a value within 0.3 mg/dl of the baseline value

Secondary outcomes

  1. Partial response

    Time frame: 10 days

    defined as a regression of at least one acute kidney injury stage with a fall in the serum creatinine value to ≥0.3 mg/dl above the baseline serum creatinine value

  2. Reversal

    Time frame: 10 days

    Incidence of HRS reversal defined as at least one serum creatinine value of ≤ 1.5 mg/dl while on treatment.

Sponsors and collaborators

Lead sponsor

National Hepatology & Tropical Medicine Research Institute

Other Gov

Registry information

Official study title

Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 21, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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