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NCT03431194 Clinical Trial

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

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03431194
Other study ID # BN-14716
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2016
Est. completion date April 6, 2017

Study information
Verified date August 2022
Source Benha University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date April 6, 2017
Est. primary completion date February 19, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• midodrine
oral midodrine tablets 5 mg
• Placebo

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Benha University New Jeddah Clinic Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Number of hypotensive episodes Number of hypotensive episodes 30 days from start of hemodialysis
Secondary mean systolic blood pressure compare mean systolic blood pressure between the two arms 30 days from start of hemodialysis
Secondary mean diastolic blood pressure compare mean diastolic blood pressure between the two arms 30 days from start of hemodialysis
Secondary Mortality in each arm Number of dead patients in each arm 30 days from start of hemodialysis
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