NCT03455322

Brief Summary

This study aimed to investigate the efficacy of midodrine plus octreotide versus norepinephrine and to determine the predictive factors of response in patients with HRS-AKI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2018

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

First Submitted

Initial submission to the registry

January 3, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

January 3, 2018

Last Update Submit

February 21, 2021

Conditions

Renal Impairment in Hepatorenal Syndrome

Outcome Measures

Primary Outcomes (1)

  • the proportion of patients achieved full response

    defined as return of sCr to a value within 0.3 mg/dl of the baseline value

    within10 days

Secondary Outcomes (5)

  • the proportion of patients achieved partial response

    within 10 days

  • Incidence of HRS reversal

    within 10 days

  • incidence of HRS-AKI relapse

    30 days

  • overall survival

    30 days

  • adverse events experienced throughout the study period in both treatment groups.

    within 10 days

Study Arms (2)

norepinephrine

ACTIVE COMPARATOR

norepinephrine continuous intravenous infusion in a dose of 0.05-0.3ug/Kg/min. average7-10 days to keep mean arterial pressure ≥ 80-100mmHg \& continued either until HRS reversal or for maximum 10 days.

Drug: norepinephrine versus midodrine & octreotide

midodrine & octreotide

ACTIVE COMPARATOR

midodrine 5mg three times/day orally \& can be increased every 24h up to 12.5mg three times daily plus octreotide 100ug/ 6h subcutaneous \& if needed increased to 200ug/6hS.C. for 7-10 days

Drug: norepinephrine versus midodrine & octreotide

Interventions

norepinephrine versus midodrine & octreotideDRUG

either intravenous infusion (IVi) norepinephrine in a dose of 0.05-0.3ug/Kg/min. to keep mean arterial pressure ≥ 80-100mmHg \& continued either until HRS reversal or for maximum 10 days or oral midodrine 5mg three times/day \& can be increased every 24h up to 12.5mg three times daily plus octreotide 100ug/ 6h subcutaneous \& if needed increased to 200ug/6h.

midodrine & octreotidenorepinephrine

Eligibility Criteria

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

You may qualify if:

  • All patients that will be included in the study have cirrhosis as diagnosed by clinical, biochemical, and ultrasound findings, with HRS type 1, the absence of bacterial infections; however, patients with bacterial infections could be included in the study if renal failure persisted after infection resolution by clinical, laboratory indices up to 48 hours.

You may not qualify if:

  • Patients will be excluded if there are advanced cardiovascular diseases due to poor prognosis or any extrahepatic disease that could affect the short-term prognosis, the presence of advanced hepatocellular carcinoma or presence of contraindication to norepinephrine as hypotension due to blood volume deficits except emergency measure, mesenteric or peripheral vascular thrombosis unless there is life-saving procedure, profound hypoxia or hypercarbia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHTMRI

Cairo, Egypt

Location

Related Publications (1)

  • El-Desoki Mahmoud EI, Abdelaziz DH, Abd-Elsalam S, Mansour NO. Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial. Front Pharmacol. 2021 Jul 2;12:675948. doi: 10.3389/fphar.2021.675948. eCollection 2021.

    PMID: 34276366DERIVED

MeSH Terms

Interventions

Octreotide

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant of Intensive care medicine, Ph D

Study Record Dates

First Submitted

January 3, 2018

First Posted

March 6, 2018

Study Start

August 15, 2018

Primary Completion

April 20, 2020

Study Completion

July 10, 2020

Last Updated

February 23, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
6 - 12 months

Locations

EG(1)