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

Study Overview
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Brief Summary
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Assess the impact of midodrine administration on weaning of IV vasopressors Assess the cost effectiveness of using midodrine in critically ill patients

Detailed Description
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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

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

Conditions
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Septic Shock

Intervention / Treatment
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* Drug: Midodrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: IV vasopressor<br>Will receive IV vasopressor infusion only | |
| Active Comparator: Midodrine<br>Will receive midodrine in addition to IV vasopressor infusion | Drug: Midodrine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of weaning of IV vasopressor in both groups | measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay | total duration of patient stay in ICU | Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days | 
| Time to ICU discharge after IV vasopressor discontinuation | measure duration from IV vasopressor stop till ICU discharge or death | 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 | 
| Time to ICU discharge after midodrine initiation | measure duration from midodrine start till ICU discharge or death | Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days | 
| Mortality | measure if patient die or discharge from the ICU | Up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Midodrine, Septic shock, Norepinephrine, Weaning