Septic Shock
Conditions
Keywords
Midodrine, Septic shock, Norepinephrine, Weaning
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
Interventions
DRUGMidodrine
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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Intervention model description
Prospective randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed