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

Sponsor

National Hepatology & Tropical Medicine Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT04522297

Collaborator

(none)

Enrollment

Location

Arms

21.3

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepato-Renal Syndrome	Drug: Midodrine/Octreotide Drug: Nor-epinephrine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 15, 2018

Actual Primary Completion Date :

Jan 23, 2020

Actual Study Completion Date :

Jan 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Midodrine/Octreotide oral midodrine plus octreotide as subcutaneous injection	Drug: Midodrine/Octreotide oral midodrine plus octreotide as subcutaneous injection Other Names: albumin at doses of 20 to 40 g/day
Active Comparator: Nor-epinephrine Intravenous infusion norepinephrine	Drug: Nor-epinephrine Intravenous infusion norepinephrine Other Names: albumin at doses of 20 to 40 g/day

Arm

Intervention/Treatment

Experimental: Midodrine/Octreotide

oral midodrine plus octreotide as subcutaneous injection

Drug: Midodrine/Octreotide

oral midodrine plus octreotide as subcutaneous injection

Other Names:

albumin at doses of 20 to 40 g/day

Active Comparator: Nor-epinephrine

Intravenous infusion norepinephrine

Drug: Nor-epinephrine

Intravenous infusion norepinephrine

Other Names:

albumin at doses of 20 to 40 g/day

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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