Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03431194
Recruitment Status : Completed
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
New Jeddah Clinic Hospital
Information provided by (Responsible Party):
Mahmoud Hamada imam, Benha University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Drug: midodrine Not Applicable

Detailed 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury
Actual Study Start Date : October 1, 2016
Actual Primary Completion Date : February 19, 2017
Actual Study Completion Date : April 6, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: midodrine group
Patients will receive midodrine tablets
 Drug: midodrine
oral midodrine tablets 5 mg
Placebo Comparator: placebo group
Patients receive sugary oral tablets therapy
 Drug: midodrine
oral midodrine tablets 5 mg


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Number of hypotensive episodes [ Time Frame: 30 days from start of hemodialysis ]
    Number of hypotensive episodes


Secondary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Mahmoud Hamada imam, Lecturer of Internal Medicine, Benha University
ClinicalTrials.gov Identifier: NCT03431194    
Other Study ID Numbers: BN-14716
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Hamada imam, Benha University:
Acute Kidney Injury
midodrine
intensive care unit
Additional relevant MeSH terms:
Layout table for MeSH terms
Acute Kidney Injury
Hypotension
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vascular Diseases
Cardiovascular Diseases
Midodrine
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Vasoconstrictor Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action