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

Phase 4

Completed

• Conditions: Septic Shock
• Interventions: Drug: Midodrine

• Registration Number: NCT03911817
• Lead Sponsor: Ain Shams University

Brief Summary

1. Assess the impact of midodrine administration on weaning of IV vasopressors

2. Assess the cost effectiveness of using midodrine in critically ill patients

Detailed 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

Study Timeline

• Study Start: 2017-11-15
• Study First Submitted: 2019-04-09
• Study First Submitted QC: 2019-04-09
• Study First Posted: 2019-04-11
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midodrine	Midodrine	Will receive midodrine in addition to IV vasopressor infusion

Primary Outcome Measures

Name	Time	Method
Time of weaning of IV vasopressor in both groups	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 Outcome Measures

Name	Time	Method
ICU length of stay	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
Time to ICU discharge after midodrine initiation	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
Mortality	Up to 30 days	measure if patient die or discharge from the ICU
Time to ICU discharge after IV vasopressor discontinuation	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

Trial Locations

Locations (1)

Critical Care Medicine Department - Cairo University Hospitals; 🇪🇬 Cairo, Egypt