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

August 18, 2020 updated by: Doaa abdelaziz, National Hepatology & Tropical Medicine Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • The National Hepatology and Tropical Research medicine institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Midodrine/Octreotide
oral midodrine plus octreotide as subcutaneous injection
Drug: Midodrine/Octreotide
oral midodrine plus octreotide as subcutaneous injection
Other Names:
  • albumin at doses of 20 to 40 g/day
Active Comparator: Nor-epinephrine
Intravenous infusion norepinephrine
Drug: Nor-epinephrine
Intravenous infusion norepinephrine
Other Names:
  • albumin at doses of 20 to 40 g/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days
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.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hepatology & Tropical Medicine Research Institute

Investigators

  • Study Director: Doaa Abdelaziz yousef, Ph.D, Fellow at The National Hepatology and Tropical Research medicine institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2018

Primary Completion (Actual)

January 23, 2020

Study Completion (Actual)

January 23, 2020

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 18, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 21, 2020

Last Update Submitted That Met QC Criteria

August 18, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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