Status:
COMPLETED
Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Acute Respiratory Distress Syndrome
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 Acetaminophe...
Detailed Description
Hypothesis 1A: Acetaminophen (APAP) or Vitamin C infusion will increase the days alive and free of organ support to day 28. Hypothesis 1B: APAP or Vitamin C will have a favorable effect on other seco...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
488 Patients enrolled
Trial Details
Trial ID
NCT04291508
Start Date
October 13 2021
End Date
July 27 2023
Last Update
September 27 2024
Active Locations (41)
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1
University of Alabama Medical Center
Birmingham, Alabama, United States, 35249
2
University of Arizona
Tucson, Arizona, United States, 85721
3
UCSF Fresno
Fresno, California, United States, 93701
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048