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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04522297

Enrollment

Registered

2020-08-21

Start date

2018-04-15

Completion date

2020-01-23

Last updated

2020-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepato-Renal Syndrome

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.

Interventions

DRUGMidodrine/Octreotide

oral midodrine plus octreotide as subcutaneous injection

DRUGNor-epinephrine

Intravenous infusion norepinephrine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Full response	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

Measure	Time frame	Description
Partial response	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
Reversal	10 days	Incidence of HRS reversal defined as at least one serum creatinine value of ≤ 1.5 mg/dl while on treatment.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026