Status:
UNKNOWN
Steroids, Thiamine and Ascorbic Acid in Septic Shock
Lead Sponsor:
Baqiyatallah Medical Sciences University
Collaborating Sponsors:
Hamadan University of Medical Science
Tehran University of Medical Sciences
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this project is to determine if in patients admitted to the hospital with septic shock (population), does treatment with a bundle including hydrocortisone, thiamine, and ascorbic acid...
Detailed Description
This trial is designed as a multi-center prospective, double-blinded, randomized controlled study. The objective of this project is to determine if in patients admitted to the hospital with septic sho...
Eligibility Criteria
Inclusion
- Septic shock admitted to the ICU within 24 hours as defined by SEPSIS-3
- SEPSIS-3 defines septic shock as sepsis with the following criteria despite adequate fluid resuscitation:
- Vasopressor required to maintain MAP ≥ 65 AND
- Serum lactate level \>2.0 mmol/L
- Age ≥ 18 years
- Non-pregnant
- Ability to consent with medical capacity or legally authorized representative (LAR) consent
Exclusion
- Age \< 18 years
- Pregnant defined by negative serum HCG in all females
- Patients with limitation of care (i.e. DNR)
- Known G6PD deficiency
- Excluding primary admission diagnosis including the following:
- Acute stroke
- Acute coronary syndrome
- Active gastrointestinal bleed
- Burn
- Trauma
- Prisoners
- \>1 episode of sepsis in hospital admission
- Vasopressor use prior to randomization for more than 24 hours
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04134403
Start Date
December 1 2019
End Date
December 1 2020
Last Update
October 22 2019
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