NCT03431194

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

February 7, 2018

Last Update Submit

August 19, 2022

Conditions

Acute Kidney Injury

Keywords

Acute Kidney Injurymidodrineintensive care unit

Outcome Measures

Primary Outcomes (1)

  • Number of hypotensive episodes

    Number of hypotensive episodes

    30 days from start of hemodialysis

Secondary Outcomes (3)

  • mean systolic blood pressure

    30 days from start of hemodialysis

  • mean diastolic blood pressure

    30 days from start of hemodialysis

  • Mortality in each arm

    30 days from start of hemodialysis

Study Arms (2)

midodrine group

ACTIVE COMPARATOR

Patients will receive midodrine tablets

Drug: midodrine

placebo group

PLACEBO COMPARATOR

Patients receive sugary oral tablets therapy

Drug: Placebo

Interventions

midodrineDRUG

oral midodrine tablets 5 mg

midodrine group
PlaceboDRUG
placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Internal Medicine

Study Record Dates

First Submitted

February 7, 2018

First Posted

February 13, 2018

Study Start

October 1, 2016

Primary Completion

February 19, 2017

Study Completion

April 6, 2017

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share