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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Hypotension
• Wounds and Injuries

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