Midodrine Effect on the Mortality Rates in Septic Shock Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-07

Study Completion Date

2024-01-24

Brief Summary

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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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Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Will receive IV vasopressor infusion only

Group Type PLACEBO_COMPARATOR

Midodrine Oral Tablet

Intervention Type 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.

Midodrine

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).

Group Type ACTIVE_COMPARATOR

Midodrine Oral Tablet

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No