Midodrine Effect on the Mortality Rates in Septic Shock Patients

Sponsor

Noha Mansour (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05778838

Collaborator

(none)

100

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Drug: Midodrine Oral Tablet	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2024

Anticipated Study Completion Date :

Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Will receive IV vasopressor infusion only	Drug: 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.
Active Comparator: 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).	Drug: 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.

Arm

Intervention/Treatment

Placebo Comparator: Control

Will receive IV vasopressor infusion only

Drug: 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.

Active Comparator: 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).

Drug: Midodrine Oral Tablet

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Noha Mansour

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noha Mansour, Principal investigator-Lecturer of Clinical Pharmacy-Clinical Pharmacy and Pharmacy Practice Department, Mansoura University

ClinicalTrials.gov Identifier:

NCT05778838

Other Study ID Numbers:

2022-211

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Shock, Septic

Shock

Midodrine

Study Results

No Results Posted as of Mar 21, 2023