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Midodrine Effect on the Mortality Rates in Septic Shock Patients

Phase 2
Completed
Conditions
Septic Shock
Interventions
Registration Number
NCT05778838
Lead Sponsor
Noha Mansour
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlMidodrine Oral TabletWill receive IV vasopressor infusion only
MidodrineMidodrine Oral TabletWill 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).
Primary Outcome Measures
NameTimeMethod
Mortality ratesTime 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Mansoura University

🇪🇬

Mansoura, Egypt

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