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

NCT ID: NCT03431194

Last Updated: 2022-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-04-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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midodrine group

Patients will receive midodrine tablets

Group Type ACTIVE_COMPARATOR

midodrine

Intervention Type DRUG

oral midodrine tablets 5 mg

placebo group

Patients receive sugary oral tablets therapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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midodrine

oral midodrine tablets 5 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Jeddah Clinic Hospital

INDUSTRY

Sponsor Role collaborator

Benha University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Hamada imam

Lecturer of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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BN-14716

Identifier Type: -

Identifier Source: org_study_id

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