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NCT05778838 Clinical Trial

Midodrine Effect on the Mortality Rates in Septic Shock Patients

Septic Shock Clinical Trial

Official title:
Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Midodrine in Septic Shock Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05778838
Other study ID # 2022-211
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2023
Est. completion date April 30, 2024

Study information
Verified date May 2023
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Assessing the safety and efficacy of the adjunctive use of midodrine as a vasopressor in septic shock patients by measuring the difference in the mortality rates between control and intervention groups.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult aged 18 years or older diagnosed with septic shock. - Hypotensive and require IV vasopressor for more than 24 hours. Exclusion Criteria: - Hypovolemic shock. - Severe organic heart disease (ejection fraction <30 percent). - Bradycardia (HR<50 b/m). - Chronic kidney disease (serum creatinine >2mg/dl). - Thyrotoxicosis. - Pheochromocytoma. - Known allergy to midodrine. - Unable to administer an oral medication.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Midodrine Oral Tablet
Patients will receive standard treatment in accordance to surviving sepsis campaign guidelines plus oral midodrine 10 mg/ 8 hours till the end of treatment (subject remaining vasopressor-free for 24 consecutive hours) or death.

Locations
Country Name City State
Egypt Mansoura University Mansoura

Sponsors (1)
Lead Sponsor Collaborator
Noha Mansour

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality rates The primary outcome is measuring the difference in ICU mortality rates between control and intervention group. Time Frame: Starting from date of randomization till shock reversal or date of death from any cause, whichever came first,assessed up to 30 days
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