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

Not Applicable

Completed

• Conditions: Hepato-Renal Syndrome
• Interventions: Drug: Midodrine/Octreotide; Drug: Nor-epinephrine

• Registration Number: NCT04522297
• Lead Sponsor: National Hepatology & Tropical Medicine Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-15
• Primary Completion: 2020-01-23
• Study Completion: 2020-01-23
• Status Verified: 2020-08
• Study First Submitted: 2020-08-18
• Study First Submitted QC: 2020-08-18
• Last Update Submitted: 2020-08-18
• Study First Posted: 2020-08-21
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midodrine/Octreotide	Midodrine/Octreotide	oral midodrine plus octreotide as subcutaneous injection
Nor-epinephrine	Nor-epinephrine	Intravenous infusion norepinephrine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The National Hepatology and Tropical Research medicine institute; 🇪🇬 Cairo, Egypt