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Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

About

Brief Summary

Prospective multi-center phase 2b randomized placebo-controlled double-blinded interventional platform trial of two different pharmacologic therapies (intravenous Vitamin C or intravenous Acetaminophen) for patients with sepsis-induced hypotension or respiratory failure.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Age ≥ 18 years
  • Sepsis defined as:
    • Clinical evidence of a known or suspected infection and orders written to administer antibiotics AND
    • Hypotension as defined by the need for any vasopressor (and 1 liter of fluid already administered intravenously for resuscitation) OR respiratory failure defined by mechanical ventilation, BIPAP or CPAP at any level, or greater than or equal to 6 liters/minute of supplemental oxygen (criterion b must be met at time of enrollment)
  • Admitted to a study site ICU (or intent for the patient to be admitted to a study site ICU) within 36 hours of presentation to the ED or admitted to the study site ICU within 36 hours of presentation to any acute care hospital

Exclusion Criteria:

  • No consent/inability to obtain consent from the participant or a legally authorized representative
  • Patient unable to be randomized within 36 hours of presentation to the ED or within 36 hours of presentation to any acute care hospital
  • Diagnosis of cirrhosis by medical chart review
  • Liver transplant recipient
  • AST or ALT greater than five times upper limit of normal
  • Diagnosis of ongoing chronic alcohol use disorder/abuse by chart review; if medical record unclear, use Appendix F
  • Clinical diagnosis of diabetic ketoacidosis or other condition such as profound hypoglycemia that requires hourly blood glucose monitoring
  • Hypersensitivity to Acetaminophen or Vitamin C
  • Patient, surrogate or physician not committed to full support (Exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
  • Home assisted ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing
  • Chronic dialysis
  • Current active kidney stone
  • Multiple (>1) episodes of prior kidney stones, known history of oxalate kidney stones, or history of oxalate nephropathy.
  • Kidney transplant recipient
  • Use of home oxygen for chronic cardiopulmonary disease
  • Moribund patient not expected to survive 24 hours
  • Underlying malignancy or other condition with estimated life expectancy of less than 1 month
  • Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding
  • Prisoner
  • Treating team unwilling to enroll because of intended use of Acetaminophen or Vitamin C
  • Treating team unwilling to use plasma (as opposed to point of care testing) for glucose monitoring.

Join this Trial

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Study Stats
Protocol No.
21-001601
Category
Pulmonary Disease
Contact
HENA SIHOTA
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04291508
For detailed technical eligibility, visit ClinicalTrials.gov.