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Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients

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: NCT03911817
Recruitment Status : Completed
First Posted : April 11, 2019
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Dina hussein ahmed eladly, Ain Shams University

Brief Summary:
  1. Assess the impact of midodrine administration on weaning of IV vasopressors
  2. Assess the cost effectiveness of using midodrine in critically ill patients

Condition or disease Intervention/treatment Phase
Septic Shock Drug: Midodrine Phase 4

Detailed Description:

A prospective randomized controlled clinical trial on total 60 critically ill patients admitted to critical care medicine department with indication to IV vasopressor due to septic shock on admission or during intensive care unit stay and they are randomly assigned to either of 2 groups as follows

  1. Group 1(n=30):will receive IV vasopressor infusion only
  2. Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective randomized controlled clinical trial
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
No Intervention: IV vasopressor
Will receive IV vasopressor infusion only
Active Comparator: Midodrine
Will receive midodrine in addition to IV vasopressor infusion
Drug: Midodrine
The oral vasoactive drug (Midodrine) at a dose of 10-20 mg every 8 hours will be used in one arm .After the blood pressure goal is met for more than 24 hours without IV vasopressor ,midodrine will be discontinued prior to discharge




Primary Outcome Measures :
  1. Time of weaning of IV vasopressor in both groups [ Time Frame: Starting from date of randomization till stop of IV vasopressor completely or date of death from any cause,whichever came first,assessed up to 30 days ]
    measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration


Secondary Outcome Measures :
  1. ICU length of stay [ Time Frame: Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days ]
    total duration of patient stay in ICU

  2. Time to ICU discharge after IV vasopressor discontinuation [ Time Frame: Starting from discontinuation of IV vasopressor until time to ICU discharge or date of death from any cause ,whichever came first,assessed up to 30 days ]
    measure duration from IV vasopressor stop till ICU discharge or death

  3. Time to ICU discharge after midodrine initiation [ Time Frame: Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days ]
    measure duration from midodrine start till ICU discharge or death

  4. Mortality [ Time Frame: Up to 30 days ]
    measure if patient die or discharge from the ICU



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients (18-80)years
  2. Hypotensive (systolic blood pressure<90mm Hg)and require IV vasopressor for more than 24 hours
  3. Require IV vasopressor at rate < 8mcg/min and unable to wean for >24 hours

Exclusion Criteria:

  1. Severe organic heart disease (ejection fraction <30 percent due to higher risk of arrythmia)
  2. Bradycardia (HR<50 b/m)due to higher likelihood of symptomatic bradycardia
  3. Chronic kidney disease (serum creatinine >2mg/dl) as midodrine and its active metabolites are almost completely execreated in urine
  4. Thyrotoxicosis
  5. Known allergy to midodrine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911817


Locations
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Egypt
Critical Care Medicine Department - Cairo University Hospitals
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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Principal Investigator: Lamiaa ELwakeel, PhD Ain Shams University

Publications:
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Responsible Party: Dina hussein ahmed eladly, clinical pharmacist, Ain Shams University
ClinicalTrials.gov Identifier: NCT03911817    
Other Study ID Numbers: 169
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dina hussein ahmed eladly, Ain Shams University:
Midodrine
Septic shock
Norepinephrine
Weaning
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Midodrine
Vasoconstrictor Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action