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OpenTrials
Completed

NCT Number: NCT03431194

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midodrine

Drug

oral midodrine tablets 5 mg

Placebo

Drug

Primary outcomes

  1. Number of hypotensive episodes

    Time frame: 30 days from start of hemodialysis

    Number of hypotensive episodes

Secondary outcomes

  1. mean systolic blood pressure

    Time frame: 30 days from start of hemodialysis

    compare mean systolic blood pressure between the two arms

  2. mean diastolic blood pressure

    Time frame: 30 days from start of hemodialysis

    compare mean diastolic blood pressure between the two arms

  3. Mortality in each arm

    Time frame: 30 days from start of hemodialysis

    Number of dead patients in each arm

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • New Jeddah Clinic Hospital

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 13, 2018
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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