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

Hepato-Renal Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04522297
• Other study ID #: 02-2018
• Status: Completed
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: August 2020
• Source: National Hepatology & Tropical Medicine Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 23, 2020
• Est. primary completion date: January 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepato-Renal Syndrome
• Hepatorenal Syndrome
• Syndrome

Intervention

Drug:
• Midodrine/Octreotide
oral midodrine plus octreotide as subcutaneous injection
• Nor-epinephrine
Intravenous infusion norepinephrine

Locations

Country	Name	City	State
Egypt	The National Hepatology and Tropical Research medicine institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Hepatology & Tropical Medicine Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

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