Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury

The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Placebo; Drug: midodrine

Detailed Description

In This open -label study, patients in ICU with acute kidney injury are randomized to either midodrine tablets or placebo. the number of intradialytic episodes and both systolic and diastolic blood pressure between both groups are compared. Mortality and adverse effects are monitored and compared as well.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ICU patients
• acute kidney injury
• age above 18 years
• documented hypotension during dialysis

Exclusion Criteria:

• packed red blood cells transfusion
• intravenous inotropes
• alteration of blood pressure medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: midodrine group; Patients will receive midodrine tablets	Drug: midodrine; oral midodrine tablets 5 mg
PLACEBO_COMPARATOR: placebo group; Patients receive sugary oral tablets therapy	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of hypotensive episodes	Number of hypotensive episodes	30 days from start of hemodialysis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean systolic blood pressure	compare mean systolic blood pressure between the two arms	30 days from start of hemodialysis
mean diastolic blood pressure	compare mean diastolic blood pressure between the two arms	30 days from start of hemodialysis
Mortality in each arm	Number of dead patients in each arm	30 days from start of hemodialysis

Collaborators and Investigators

• Sponsor: Benha University
• Collaborators: New Jeddah Clinic Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): February 19, 2017
• Study Completion (ACTUAL): April 6, 2017

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (ACTUAL): February 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: intensive care unit; Acute Kidney Injury; midodrine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury; Hypotension; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Sympathomimetics; Vasoconstrictor Agents; Adrenergic alpha-1 Receptor Agonists; Midodrine
• Other Study ID Numbers: BN-14716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No