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Completed

NCT Number: NCT03911817

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

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

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Critical Care Medicine Department - Cairo University Hospitals

Cairo, Egypt

About this study

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

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Midodrine

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2019
Registry last updated
Jan 9, 2020

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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