Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery (NCT04291508) | Clinical Trial Compass
CompletedPhase 2
Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery
United States488 participantsStarted 2021-10-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Days Alive and Free of Organ Support to Day 28
Timeframe: 28 days after randomization
2
28-day All Cause Mortality
Timeframe: 28 days after randomization
3
Days Free of Assisted Ventilation to Day 28
Timeframe: 28 days after randomization
4
Days Free of Renal Replacement Therapy to Day 28 in Overall Cohort
Timeframe: 28 days after randomization
5
Days Free of Vasopressors to Day 28 in Overall Cohort
. 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)