Acetaminophen and Ascorbate in Sepsis: Targeted Therapy to Enhance Recovery

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Respiratory Distress Syndrome, Critical Illness, Respiratory Failure, Sepsis

In brief

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.

Key facts

Study ID

NCT04291508

Run by

Massachusetts General Hospital

People needed

488

Starts

2021-10-13

Expected to finish

2023-07-27

Last updated by the study team

2024-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• University of Alabama Medical Center — Birmingham, Alabama, United States
• University of Arizona — Tucson, Arizona, United States
• UCSF Fresno — Fresno, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Denver Health Medical Center — Denver, Colorado, United States
• University Medical Center — New Orleans, Louisiana, United States
• Maine Medical Center — Portland, Maine, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Henry Ford Medical Center — Detroit, Michigan, United States
• Fairview Southdale Hospital — Edina, Minnesota, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Mt. Sinai Hospital — New York, New York, United States
• Montefiore Medical Center-Weiler — The Bronx, New York, United States
• Montefiore Medical Center-Moses — The Bronx, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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