Back to resultsMidodrine Effect on the Mortality Rates in Septic Shock Patients
Primary Purpose
Septic Shock
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Midodrine Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock
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.
Sites / Locations
- Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Control
Midodrine
Arm Description
Will receive IV vasopressor infusion only
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).
Outcomes
Primary Outcome Measures
Mortality rates
The primary outcome is measuring the difference in ICU mortality rates between control and intervention group.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05778838
Brief Title
Midodrine Effect on the Mortality Rates in Septic Shock Patients
Official Title
Clinical Study Evaluating the Efficacy and Safety of Adjunctive Use of Midodrine in Septic Shock Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Noha Mansour
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Will receive IV vasopressor infusion only
Arm Title
Midodrine
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Midodrine Oral Tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mortality rates
Description
The primary outcome is measuring the difference in ICU mortality rates between control and intervention group.
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Mansoura University
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noha Mansour
Phone
01221610667
Email
nohamansaur@mans.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Midodrine Effect on the Mortality Rates in Septic Shock Patients
We'll reach out to this number within 24 hrs