Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial

Background: Terlipressin is the first-line pharmacological treatment for hepatorenal syndrome. When terlipressin is unavailable, midodrine/octreotide or norepinephrine, with albumin, represent the alternative treatments. The comparative efficacy of these alternative regimens remains unclear.Objectiv...

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Main Authors: Eman Ibrahim El-Desoki Mahmoud, Doaa H Abdelaziz, Sherief Abd-Elsalam, Noha O. Mansour
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-07-01
Series:Frontiers in Pharmacology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fphar.2021.675948/full
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spelling doaj-808b6234ea9c40f09e8aca5b980ddcb12021-07-02T06:02:40ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122021-07-011210.3389/fphar.2021.675948675948Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled TrialEman Ibrahim El-Desoki Mahmoud0Doaa H Abdelaziz1Doaa H Abdelaziz2Sherief Abd-Elsalam3Noha O. Mansour4Intensive Care Medicine, National Hepatology and Tropical Medicine Research Institute, Cairo, EgyptDepartment of Clinical Pharmacy, The National Hepatology and Tropical Medicine Research Institute, Cairo, EgyptPharmacy Practice and Clinical Pharmacy Department, Faculty of Pharmacy, Future University in Egypt, Cairo, EgyptDepartment of Tropical Medicine and Infectious Diseases, Faculty of Medicine, Tanta University, Tanta, EgyptClinical Pharmacy and Pharmacy Practice Department, Faculty of Pharmacy, Mansoura University, Mansoura, EgyptBackground: Terlipressin is the first-line pharmacological treatment for hepatorenal syndrome. When terlipressin is unavailable, midodrine/octreotide or norepinephrine, with albumin, represent the alternative treatments. The comparative efficacy of these alternative regimens remains unclear.Objective: To compare the efficacy of midodrine/octreotide to that of norepinephrine for the treatment of patients with hepatorenal syndrome.Methods: In the intensive care setting, sixty patients with hepatorenal syndrome were randomized to initially receive either 0.5 mg/h of norepinephrine (maximum 3 mg/h) or 5 mg of oral midodrine three times/day (maximum 12.5 mg three times/day) plus octreotide (100 μg/6 h) as subcutaneous injection (maximum 200 μg/6 h), together with albumin (20–40 g/day). Treatment was allowed for a maximum of 10 days. Survival was analyzed for up to 30 days. The primary efficacy outcome was the proportion of patients who achieved full response, defined as the return of serum creatinine to a value within 0.3 mg/dl of the baseline at the end of treatment.Results: There was a significantly higher rate of full response in the norepinephrine group (15/26, 57.60%) than the midodrine/octreotide group (5/25, 20%) (p = 0.006). Eleven (42.30%) patients in the norepinephrine group and 6 (24%) in the midodrine/octreotide group survived (p = 0.166).Conclusion: Norepinephrine plus albumin is significantly more effective than midodrine and octreotide plus albumin in improving renal function in patients with hepatorenal syndrome.(ClinicalTrials.gov, identifier: NCT03455322).https://clinicaltrials.gov/ct2/show/NCT03455322?cond = Hepatorenal+Syndrome&cntry = EG&draw = 2&rank = 1.https://www.frontiersin.org/articles/10.3389/fphar.2021.675948/fullnorepinephrinemidodrine /octreotidehepatorenal syndromeacute kidney injuryintensive carecirrhosis
collection DOAJ
language English
format Article
sources DOAJ
author Eman Ibrahim El-Desoki Mahmoud
Doaa H Abdelaziz
Doaa H Abdelaziz
Sherief Abd-Elsalam
Noha O. Mansour
spellingShingle Eman Ibrahim El-Desoki Mahmoud
Doaa H Abdelaziz
Doaa H Abdelaziz
Sherief Abd-Elsalam
Noha O. Mansour
Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial
Frontiers in Pharmacology
norepinephrine
midodrine /octreotide
hepatorenal syndrome
acute kidney injury
intensive care
cirrhosis
author_facet Eman Ibrahim El-Desoki Mahmoud
Doaa H Abdelaziz
Doaa H Abdelaziz
Sherief Abd-Elsalam
Noha O. Mansour
author_sort Eman Ibrahim El-Desoki Mahmoud
title Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial
title_short Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial
title_full Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial
title_fullStr Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial
title_full_unstemmed Norepinephrine is More Effective Than Midodrine/Octreotide in Patients With Hepatorenal Syndrome-Acute Kidney Injury: A Randomized Controlled Trial
title_sort norepinephrine is more effective than midodrine/octreotide in patients with hepatorenal syndrome-acute kidney injury: a randomized controlled trial
publisher Frontiers Media S.A.
series Frontiers in Pharmacology
issn 1663-9812
publishDate 2021-07-01
description Background: Terlipressin is the first-line pharmacological treatment for hepatorenal syndrome. When terlipressin is unavailable, midodrine/octreotide or norepinephrine, with albumin, represent the alternative treatments. The comparative efficacy of these alternative regimens remains unclear.Objective: To compare the efficacy of midodrine/octreotide to that of norepinephrine for the treatment of patients with hepatorenal syndrome.Methods: In the intensive care setting, sixty patients with hepatorenal syndrome were randomized to initially receive either 0.5 mg/h of norepinephrine (maximum 3 mg/h) or 5 mg of oral midodrine three times/day (maximum 12.5 mg three times/day) plus octreotide (100 μg/6 h) as subcutaneous injection (maximum 200 μg/6 h), together with albumin (20–40 g/day). Treatment was allowed for a maximum of 10 days. Survival was analyzed for up to 30 days. The primary efficacy outcome was the proportion of patients who achieved full response, defined as the return of serum creatinine to a value within 0.3 mg/dl of the baseline at the end of treatment.Results: There was a significantly higher rate of full response in the norepinephrine group (15/26, 57.60%) than the midodrine/octreotide group (5/25, 20%) (p = 0.006). Eleven (42.30%) patients in the norepinephrine group and 6 (24%) in the midodrine/octreotide group survived (p = 0.166).Conclusion: Norepinephrine plus albumin is significantly more effective than midodrine and octreotide plus albumin in improving renal function in patients with hepatorenal syndrome.(ClinicalTrials.gov, identifier: NCT03455322).https://clinicaltrials.gov/ct2/show/NCT03455322?cond = Hepatorenal+Syndrome&cntry = EG&draw = 2&rank = 1.
topic norepinephrine
midodrine /octreotide
hepatorenal syndrome
acute kidney injury
intensive care
cirrhosis
url https://www.frontiersin.org/articles/10.3389/fphar.2021.675948/full
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