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Trial · Interventional

CompletedPhase 4Registry data

Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.

NCTNCT03455322 (opens ClinicalTrials.gov in a new tab)Other idNHTMRI-2
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Overview

Status
Completed
Phase
Phase 4
Enrollment
60 participants (actual)
Sponsor
National Hepatology & Tropical Medicine Research Institute · Other gov
Design
Randomized · Single masking
Countries
1 country

Egypt

Start
15 Aug 2018
Primary completion
20 Apr 2020
Completion
10 Jul 2020
First posted
6 Mar 2018
Last update posted
23 Feb 2021
Conditions
Renal Impairment in Hepatorenal Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2018201920202021
  1. Ph 4

    Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.

    NCT03455322

    15 Aug 2018 to 10 Jul 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • norepinephrine versus midodrine & octreotideDrug

Arms2

  • Active comparator

    norepinephrine

    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.

  • Active comparator

    midodrine & octreotide

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. the proportion of patients achieved full response

    Time frame · within10 days

    Registry description

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

Secondary outcomes(5)

  1. the proportion of patients achieved partial response

    Time frame · within 10 days

    Registry description

    defined as a regression of at least one AKI stage with a fall in the sCr value to ≥0.3 mg/dl above the baseline value

  2. Incidence of HRS reversal

    Time frame · within 10 days

    Registry description

    defined as at least one sCr value of ≤ 1.5 mg/dl while on treatment

  3. incidence of HRS-AKI relapse

    Time frame · 30 days

    Registry description

    relapse of HRS-AKI after cessation of treatment

  4. overall survival

    Time frame · 30 days

    Registry description

    patients who are survived

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

    Time frame · within 10 days

    Registry description

    The incidence of hepatic encephalopathy episodes, bacterial infections, gastrointestinal bleeding, myocardial infarction, arrhythmia, circulatory overload and arterial hypertension was assessed at the end of the study. The need for mechanical ventilation and the need for dialysis.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2021

Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial.

El-Desoki Mahmoud et al. 2021Frontiers in pharmacologycited by 27

PMID 34276366PMC8283260DOI 10.3389/fphar.2021.675948PUB-34276366

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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