Steroids, Thiamine and Ascorbic Acid in Septic Shock

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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 improve in-hospital or 28-day mortality (primary outcomes) or surrogate markers of illness severity including: (1) ICU or hospital length-of-stay, (2) duration of invasive mechanical ventilation, (3) duration of vasopressor administration, (4) incidence and severity of ICU delirium, and (5) illness severity (secondary outcomes).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baqiyatallah Medical Sciences University
• Collaborators: Hamadan University of Medical Science; Tehran University of Medical Sciences
• Treatments: Ascorbic Acid; Thiamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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