Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis UCLA UCSF
Dates
study started
estimated completion

Description

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.

Details

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 secondary outcomes including pulmonary and non-pulmonary organ dysfunction and biomarkers of inflammation and endothelial injury The investigators plan to carry out two multi-center phase 2b randomized double-blinded placebo-controlled trials of two different pharmacologic therapies within a single platform trial. 1. One trial will assess the efficacy of Acetaminophen (1 gram intravenously every 6 hours) for 120 hours in patients with sepsis who have evidence of either hemodynamic or respiratory organ failure. 2. A second trial will assess the efficacy of Vitamin C (50 mg/kg every 6 hours) infused intravenously for 120 hours in patients with sepsis who have evidence of either hemodynamic or respiratory organ failure. A total of 900 participants who meet all of the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1:2:1 fashion (APAP-Active: APAP-Placebo: Vit C-Active: Vit C-Placebo).

Keywords

Acute Respiratory Distress Syndrome Critical Illness Respiratory Failure Sepsis ARDS Acetaminophen Vitamin C Toxemia Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Insufficiency Acute Lung Injury Ascorbic Acid Intravenous Acetaminophen (room temperature) Intravenous Vitamin C (refrigerated) 5% Dextrose (room temperature) 5% Dextrose refrigerated

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Age ≥ 18 years
  2. Sepsis defined as:
  3. Clinical evidence of a known or suspected infection and orders written to administer antibiotics AND
  4. 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)
  5. 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 CAN'T join if...

  1. No consent/inability to obtain consent from the participant or a legally authorized representative
  2. Patient unable to be randomized within 36 hours of presentation to the ED or within 36 hours of presentation to any acute care hospital
  3. Diagnosis of cirrhosis by medical chart review
  4. Liver transplant recipient
  5. AST or ALT greater than five times upper limit of normal
  6. Diagnosis of ongoing chronic alcohol use disorder/abuse by chart review; if medical record unclear, use Appendix F
  7. Clinical diagnosis of diabetic ketoacidosis or other condition such as profound hypoglycemia that requires hourly blood glucose monitoring
  8. Hypersensitivity to Acetaminophen or Vitamin C
  9. 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)
  10. . Home assisted ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing
  11. . Chronic dialysis
  12. . Current active kidney stone
  13. . Multiple (>1) episodes of prior kidney stones, known history of oxalate kidney stones, or history of oxalate nephropathy.
  14. . Kidney transplant recipient
  15. . Use of home oxygen for chronic cardiopulmonary disease
  16. . Moribund patient not expected to survive 24 hours
  17. . Underlying malignancy or other condition with estimated life expectancy of less than 1 month
  18. . 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
  19. . Prisoner
  20. . Treating team unwilling to enroll because of intended use of Acetaminophen or Vitamin C
  21. . Treating team unwilling to use plasma (as opposed to point of care testing) for glucose monitoring.

Locations

  • UCSF Fresno
    Fresno California 93701 United States
  • Ronald Reagan UCLA Medical Center
    Los Angeles California 90095 United States
  • UC Davis Medical Center
    Sacramento California 95817 United States
  • UCSF Medical Center
    San Francisco California 94143 United States
  • Cedars-Sinai Medical Center
    Los Angeles California 90048 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts General Hospital
Links
Website for the PETAL Network
ID
NCT04291508
Phase
Phase 2
Study Type
Interventional
Last Updated