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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT03911817

Collaborator

(none)

Enrollment

Location

Arms

20.4

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Drug: Midodrine	Phase 4

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

Group 1(n=30):will receive IV vasopressor infusion only
Group 2(n=30):will receive midodrine in addition to IV vasopressor infusion

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective randomized controlled clinical trialProspective randomized controlled clinical trial

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 15, 2017

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jul 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: IV vasopressor Will receive IV vasopressor infusion only
Active Comparator: Midodrine Will receive midodrine in addition to IV vasopressor infusion	Drug: 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

Arm

Intervention/Treatment

No Intervention: IV vasopressor

Will receive IV vasopressor infusion only

Active Comparator: Midodrine

Will receive midodrine in addition to IV vasopressor infusion

Drug: 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

Outcome Measures

Primary Outcome Measures

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

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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