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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Septic Shock

Treatments: Drug: Midodrine

Study type: Interventional

Funder types: Other

Identifiers

NCT03911817

169

Details and patient eligibility

About

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

Full 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

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

IV vasopressor

No Intervention group

Description:

Will receive IV vasopressor infusion only

Midodrine

Active Comparator group

Description:

Will receive midodrine in addition to IV vasopressor infusion

Treatment:

Drug: Midodrine