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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2019-07-30

Brief Summary

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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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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

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

Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective randomized controlled clinical trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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IV vasopressor

Will receive IV vasopressor infusion only

Group Type NO_INTERVENTION

No interventions assigned to this group

Midodrine

Will receive midodrine in addition to IV vasopressor infusion

Group Type ACTIVE_COMPARATOR

Midodrine

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No