| Primary | Days Alive and Free of Organ Support to Day 28 | Defined as the days alive and free of organ support (dialysis, assisted ventilation, and vasopressors) to day 28. Participants will need to be free of all three components (assisted ventilation, vasopressors, new renal replacement therapy) to qualify for a day alive and free from organ failures. Patients on chronic dialysis will not be scored for the new renal failure free component of this outcome. | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) | | OG003 | Vitamin C-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). Note: This arm is now closed. 5% Dextrose refrigerated: Placebo (identical appearing refrigerated 5% dextrose solution) infused every six hours for 5 days (20 doses) |
| | Units | Counts |
|---|
| Participants | - OG000223
- OG00140
- OG002197
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00020.2± 10.6
- OG00120.5± 9.5
- OG00219.7± 10.5
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | 0.65 | | Mean Difference (Final Values) | 0.5 | | | 2-Sided | 95 | -1.6 | 2.5 | | | | | Superiority | | | | | t-test, 2 sided | | 0.464 | |
|
| Primary | 28-day All Cause Mortality | Vital status at study day 28 regardless of location or cause of death. Patients discharged from the study hospital are followed to day 29 to determine this endpoint. | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Count of Participants | | Participants | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo |
|
| Primary | Days Free of Assisted Ventilation to Day 28 | The number of days alive and without assisted ventilation (midnight to midnight) in the overall cohort. No penalty for death. | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | |
|
| Primary | Days Free of Renal Replacement Therapy to Day 28 in Overall Cohort | The number of days alive and without renal replacement (RRT) in the overall cohort. If a participant was not on RRT at randomization, received RRT every other day, and stopped RRT before day 28, the number of renal replacement free days is the sum of the days free of RRT prior to dialysis starting and the number of days after dialysis stopped (begins with the first day, midnight to midnight, the participant was free of RRT). No penalty for death. | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) |
|
| Primary | Days Free of Vasopressors to Day 28 in Overall Cohort | Days free of vasopressors to day 28 are defined as the number of calendar days (midnight to midnight) between randomization and 28 days later that the patient is alive and did not receive vasopressor therapy. | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo |
|
| Secondary | Ventilator-free Days (VFD) | VFDs depend on both duration of ventilation and mortality through study day 28. In participants who survive 28 days, VFD is defined as 28 minus days of invasive or noninvasive ventilation to day 28. Duration of ventilation is counted from the first study day of assisted breathing through the last day of assisted breathing provided the last day is prior to day 28. Isolated periods of ventilation briefer than 24 hours for surgical procedures and ventilation solely for sleep disordered breathing do not count towards duration of ventilation. In participants who never require assisted breathing, duration of ventilation is zero. Participants who do not survive 28 days will be assigned zero VF | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) |
|
| Secondary | Vasopressor-free Days | Vasopressor free days to day 28 are defined as the number of calendar days between randomization and 28 days later that the patient is alive and without the use of vasopressor therapy. Patients who die prior to day 28 and those who receive vasopressor therapy for the entire first 28 days are assigned zero vasopressor free days. | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | |
|
| Secondary | Renal Replacement-free Days | Renal replacement free days to day 28 are defined as the number of calendar days between randomization and 28 days later that the patient is alive and without renal replacement therapy. We also follow the "last off" method. Patients who died prior to day 28 and those who receive renal replacement therapy for the entire first 28 days are assigned zero renal replacement free days. | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) |
|
| Secondary | 28 Day Hospital Mortality | All deaths occuring in the study hospital until study day 28. | Data needed to determine this outcome was missing in 3 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Count of Participants | | Participants | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
|
| Secondary | ICU Free Days | The number of days spent alive out of the ICU to day 28. | Data needed to determine this outcome was missing in 4 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
|
| Secondary | Hospital Free Days to Discharge Home | Defined as 28 days minus the number of days from randomization to discharge home. If a patient has not been discharged home prior to study day 28 or dies prior to day 28, hospital free days will be zero. Patients transferred to another hospital or other health care facility will be followed to day 28 to assess this endpoint. | Data needed to determine this outcome was missing in 3 patients in the Acetaminophen active arm and 2 patients in the Acetaminophen placebo arm. | Posted | | Mean | Standard Deviation | days | | Up to day 28 | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | |
|
| Secondary | Number of Subjects With Initiation of Assisted Ventilation | Any patient who received assisted ventilation during the study hospitalization to study day 28 days meets this endpoint. | | Posted | | Count of Participants | | Participants | | Up to day 28 | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
|
| Secondary | Number of Subjects With Initiation of Renal Replacement Therapy | Patients who receive (new) renal replacement therapy through day 28 will meet this endpoint. Patients with chronic renal replacement therapy initiated prior to the current sepsis illness will not be eligible to meet this endpoint. | | Posted | | Count of Participants | | Participants | | Up to day 28 | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
|
| Secondary | Change in Organ-specific Sepsis-related Organ Failure Assessment (SOFA) Scores Between Enrollment and Study Day 7 | SOFA score calculated upon enrollment and at day 7 using clinically available data. If a value is not available at baseline, it will be assumed to be normal. Missing values at day 7 assessment were carried forward to the closest known value. GSC was omitted for patients intubated/heavily sedated at either 0 or day 7 when calculating the change in score. Renal dysfunction component was omitted for patients RRT prior to presentation.Higher SOFA score=worse outcome.ASTER clinically significant organ failure:SOFA score 2 or more points higher than baseline.Total score range: 0(min)-24(max) Score:Coag(platelets x10³/µL:0:>150;1:</=150; 2:</=100; 3:</=50; 4:</=20. Liver(bilirubin, mg/dL): 0:<1.2; 1: 1.2-1.9; 3: 2.0-5.9; 3: 6.0-11.9; 4:>11.9. Cardio(hypotension): 0:none; 1: MAP <70 mmHg; 2: Dop</=5 or dob (any dose); 3:dop>5, epi</=0.1, or norepi</=0.1; 4: Dop>15, epi>0.1, or norepi>0.1. Renal(Cr, mg/dL or urine output,ml/d): 0:<1.2; 1: 1.2-1.9; 3: 2.0-3.4; 3: 3.5-4.9 or <500; 4:>4.9 or<200. | | Posted | | Mean | Standard Deviation | score on a scale | | Day 0-Day 7 | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 |
|
| Secondary | Renal Calculi to Day 90 | Renal calculi diagnosed between randomization and study day 90 in patients in the Vitamin C-Active/Vitamin C-Placebo group. | Renal calculi diagnosed between randomization and study day 90 in patients in the Vitamin C-Active/Vitamin C-Placebo group. | Posted | | Count of Participants | | Participants | | Up to day 90 | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
|
| Secondary | 90-day All-cause Mortality | Vital status of the patient at day 90 will be determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, review of obituaries, or information from the Centers for Disease Control and Prevention's National Death Index (NDI). | | Posted | | Count of Participants | | Participants | | 90 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
|
| Secondary | 90-day Hospital Mortality | Vital status prior to discharge home before day 90. | | Posted | | Count of Participants | | Participants | | 90 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
|
| Secondary | Number of Subjects Who Developed ARDS Within 7 Days of Randomization | The presence of ARDS for each day is defined as receiving assisted ventilation with P/F <300 or imputed P/F <300, FiO2 ≥40%, and PEEP ≥5 cm H2O and not fully explained by CHF or fluid overload. ARDS imaging criteria are met if clinically available chest images (CT or CXR) are consistent with ARDS (bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules). | | Posted | | Count of Participants | | Participants | | Up to day 7 | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo |
|
| Secondary | Change in Serum Creatinine Concentration | We will measure the change in serum creatinine from enrollment to discharge, death, initiation of dialysis or 28 days, whichever occurs first | | Posted | | Mean | Standard Deviation | mg/dL | | Up to day 28 | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
|
| Secondary | Number of Subjects With Major Adverse Kidney Events at 28 Days (MAKE28) | Defined as persistent increase in serum creatinine by 200% from baseline, need for new renal replacement therapy, or death | | Posted | | Count of Participants | | Participants | | 28 days after randomization | | | | ID | Title | Description |
|---|
| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
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| Secondary | ICU Days to Day 28 | ICU free days to day 28 are defined as the number of days spent alive and out of the ICU to day 28. | | Posted | | Mean | Standard Deviation | days | | To day 28 | | | | ID | Title | Description |
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| OG000 | IV Acetaminophen-Active | Patients randomized to the Acetaminophen arm will receive Acetaminophen at the dose of 1 gram (or 15 mg/kg if actual body weight < 50kg) in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Intravenous Acetaminophen (room temperature): Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses) | | OG001 | IV Vitamin C-Active | Patients randomized to the Vitamin C arm will receive Vitamin C at the dose of 50 mg/kg in 100 ml 5% dextrose in water every 6 hours intravenously for 5 days (20 doses). Note: This arm is now closed. Intravenous Vitamin C (refrigerated): Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses) | | OG002 | Acetaminophen-Placebo | Patients randomized to placebo will receive an identical-appearing intravenous infusion of 100 ml of 5% dextrose in water every 6 hours for 5 days (20 doses). 5% Dextrose (room temperature): Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses) |
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