What is the Purpose of this Study?
Not Available
Eligibility
- 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
- 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 (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial)
- 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 (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial)
- Multiple (>1) episodes of prior kidney stones, known history of oxalate kidney stones, or history of oxalate nephropathy. (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial)
- Kidney transplant recipient (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial)
- Use of home oxygen >3L/minute via nasal cannula 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 (applicable to the 4 arm (Vitamin C/placebo vs. Acetaminophen/placebo) phase of the trial).
Inclusion Criteria:
Exclusion Criteria:
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery
Study Details
Disease Type/Condition
Other
Principal Investigator
Chen, Peter
Age Group
Adult
Phase
II
IRB Number
STUDY00001668
ClinicalTrials.gov ID
NCT04291508
Key Eligibility
ClinicalTrials.gov How do I learn more about this study?
Email
clinicaltrials@cshs.org