Midodrine Effect on the Mortality Rates in Septic Shock Patients

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.

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Key information

Conditions

Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mansoura University

Al Mansurah, 35516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Midodrine Oral Tablet

Drug

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.

Primary outcomes

Mortality rates

Time frame: 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

The primary outcome is measuring the difference in ICU mortality rates between control and intervention group.

Sponsors and collaborators

Lead sponsor

Noha Mansour

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Mar 21, 2023
Registry last updated: Mar 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed