NCT04522297

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

1.8 years

First QC Date

August 18, 2020

Last Update Submit

August 18, 2020

Conditions

Hepato-Renal Syndrome

Outcome Measures

Primary Outcomes (1)

  • Full response

    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 Outcomes (2)

  • Partial response

    10 days

  • Reversal

    10 days

Study Arms (2)

Midodrine/Octreotide

EXPERIMENTAL

oral midodrine plus octreotide as subcutaneous injection

Drug: Midodrine/Octreotide

Nor-epinephrine

ACTIVE COMPARATOR

Intravenous infusion norepinephrine

Drug: Nor-epinephrine

Interventions

Midodrine/OctreotideDRUG

oral midodrine plus octreotide as subcutaneous injection

Also known as: albumin at doses of 20 to 40 g/day
Midodrine/Octreotide
Nor-epinephrineDRUG

Intravenous infusion norepinephrine

Also known as: albumin at doses of 20 to 40 g/day
Nor-epinephrine

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The National Hepatology and Tropical Research medicine institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Hepatorenal Syndrome

Interventions

MidodrineOctreotide

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Doaa Abdelaziz yousef, Ph.D

    Fellow at The National Hepatology and Tropical Research medicine institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of clinical pharmacy

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 21, 2020

Study Start

April 15, 2018

Primary Completion

January 23, 2020

Study Completion

January 23, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)