Back to resultsNor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Syndrome
Primary Purpose
Hepato-Renal Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Midodrine/Octreotide
Nor-epinephrine
Sponsored by
About this trial
This is an interventional treatment trial for Hepato-Renal Syndrome
Eligibility Criteria
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
Sites / Locations
- The National Hepatology and Tropical Research medicine institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Midodrine/Octreotide
Nor-epinephrine
Arm Description
oral midodrine plus octreotide as subcutaneous injection
Intravenous infusion norepinephrine
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Reversal
Incidence of HRS reversal defined as at least one serum creatinine value of ≤ 1.5 mg/dl while on treatment.
Full Information
NCT ID
NCT04522297
First Posted
August 18, 2020
Last Updated
August 18, 2020
Sponsor
National Hepatology & Tropical Medicine Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04522297
Brief Title
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Syndrome
Official Title
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Acute Kidney Injury
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2018 (Actual)
Primary Completion Date
January 23, 2020 (Actual)
Study Completion Date
January 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Hepatology & Tropical Medicine Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepato-Renal Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Midodrine/Octreotide
Arm Type
Experimental
Arm Description
oral midodrine plus octreotide as subcutaneous injection
Arm Title
Nor-epinephrine
Arm Type
Active Comparator
Arm Description
Intravenous infusion norepinephrine
Intervention Type
Drug
Intervention Name(s)
Midodrine/Octreotide
Other Intervention Name(s)
albumin at doses of 20 to 40 g/day
Intervention Description
oral midodrine plus octreotide as subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Nor-epinephrine
Other Intervention Name(s)
albumin at doses of 20 to 40 g/day
Intervention Description
Intravenous infusion norepinephrine
Primary Outcome Measure Information:
Title
Full response
Description
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
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Partial response
Description
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
Time Frame
10 days
Title
Reversal
Description
Incidence of HRS reversal defined as at least one serum creatinine value of ≤ 1.5 mg/dl while on treatment.
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doaa Abdelaziz yousef, Ph.D
Organizational Affiliation
Fellow at The National Hepatology and Tropical Research medicine institute
Official's Role
Study Director
Facility Information:
Facility Name
The National Hepatology and Tropical Research medicine institute
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nor-epinephrine Versus Midodrine/Octreotide in Patients With Hepatorenal Syndrome
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