Clinical trial NCT03911817: Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients
Official title: Impact of Midodrine Administration on the Clinical Outcome of Septic Shock Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Keywords: Midodrine
Septic shock
Norepinephrine
Weaning
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Time of weaning of IV vasopressor in both groups
timeFrame: 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:
measure: ICU length of stay
timeFrame: Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
measure: Time to ICU discharge after IV vasopressor discontinuation
timeFrame: 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: Time to ICU discharge after midodrine initiation
timeFrame: Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
measure: Mortality
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Critical Care Medicine Department - Cairo University Hospitals
Study officials:
affiliation: Ain Shams University
name: Lamiaa ELwakeel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anstey MH, Wibrow B, Thevathasan T, Roberts B, Chhangani K, Ng PY, Levine A, DiBiasio A, Sarge T, Eikermann M. Midodrine as adjunctive support for treatment of refractory hypotension in the intensive care unit: a multicenter, randomized, placebo controlled trial (the MIDAS trial). BMC Anesthesiol. 2017 Mar 21;17(1):47. doi: 10.1186/s12871-017-0339-x.
citation: Whitson MR, Mo E, Nabi T, Healy L, Koenig S, Narasimhan M, Mayo PH. Feasibility, Utility, and Safety of Midodrine During Recovery Phase From Septic Shock. Chest. 2016 Jun;149(6):1380-3. doi: 10.1016/j.chest.2016.02.657. Epub 2016 Mar 4.