Midodrine Effect on the Mortality Rates in Septic Shock Patients

Noha Mansour

Status and phase: Completed; Phase 2

Conditions: Septic Shock

Treatments: Drug: Midodrine Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05778838

2022-211

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Will receive IV vasopressor infusion only

Treatment:

Drug: Midodrine Oral Tablet

Midodrine

Active Comparator group

Description:

Will receive oral midodrine 10 mg/ 8 hours in addition to IV vasopressor infusion till the end of treatment (subject remaining vasopressor-free for 24 consecutive hours).

Treatment:

Drug: Midodrine Oral Tablet