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

Ain Shams University60 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Septic Shock

Interventions

MidodrineDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Critical Care Medicine Department - Cairo University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

ICU length of stay

total duration of patient stay in ICU

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

Time to ICU discharge after IV vasopressor discontinuation

measure duration from IV vasopressor stop till ICU discharge or death

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

Time to ICU discharge after midodrine initiation

measure duration from midodrine start till ICU discharge or death

Time frame: 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

Time frame: Up to 30 days

Data from ClinicalTrials.gov

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