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

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911817
• Other study ID #: 169
• Status: Completed
• Phase: Phase 4
• Start date: November 15, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: January 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
Egypt	Critical Care Medicine Department - Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of weaning of IV vasopressor in both groups	measure duration needed to completely stop IV vasopressor in both groups and the impact of adding midodrine on that duration	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	ICU length of stay	total duration of patient stay in ICU	Starting from date of randomization until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
Secondary	Time to ICU discharge after IV vasopressor discontinuation	measure duration from IV vasopressor stop till ICU discharge or death	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
Secondary	Time to ICU discharge after midodrine initiation	measure duration from midodrine start till ICU discharge or death	Starting from midodrine initiation until ICU discharge or date of death from any cause,whichever came first,assessed up to 30 days
Secondary	Mortality	measure if patient die or discharge from the ICU	Up to 30 days