Clinical trial

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

Name

2022-211

Description

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.

Trial arms

Trial start

2023-04-01

Estimated PCD

2024-04-30

Trial end

2024-04-30

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Control, Midodrine

Size

100

Primary endpoint

Mortality rates

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

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-05-23

1 organization

1 product

1 indication

Organization

Noha Mansour

Product

Midodrine

Indication

Septic shock