Midodrine Effect on the Mortality Rates in Septic Shock Patients

NCT05778838 | Completed Phase 2 DMC

• 1 other identifier: 2022-211
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control

PLACEBO COMPARATOR

Will receive IV vasopressor infusion only

Drug: Midodrine Oral Tablet

Midodrine

ACTIVE COMPARATOR

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).

Drug: Midodrine Oral Tablet

Interventions

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.

Control; Midodrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged 18 years or older diagnosed with septic shock.
• Hypotensive and require IV vasopressor for more than 24 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Noha Mansour: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Midodrine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 21, 2023
• Study Start: November 7, 2022
• Primary Completion: December 22, 2023
• Study Completion: January 24, 2024
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)