Trial Outcomes & Findings for Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial (NCT NCT03389555)

NCT ID: NCT03389555

Last Updated: 2021-02-16

Results Overview

Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours. The SOFA score ranges from a minimum of 0 to a maximum of 24, with higher scores meaning worse outcomes.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 205 participants
• Primary outcome timeframe: Enrollment to 72-hours
• Results posted on: 2021-02-16

Participant Flow

Participant milestones

Measure	Vitamin C, Vitamin B1, Corticosteroids The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Overall Study STARTED	103	102
Overall Study COMPLETED	101	99
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	Vitamin C, Vitamin B1, Corticosteroids The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Overall Study Protocol Violation	1	3
Overall Study Death	1	0

Baseline Characteristics

Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.

Baseline characteristics by cohort

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components	Total n=200 Participants Total of all reporting groups
Age, Continuous	68.9 years STANDARD_DEVIATION 15.0 • n=101 Participants	67.7 years STANDARD_DEVIATION 13.9 • n=99 Participants	68.2 years STANDARD_DEVIATION 14.5 • n=200 Participants
Sex: Female, Male Female	44 Participants n=101 Participants	45 Participants n=99 Participants	89 Participants n=200 Participants
Sex: Female, Male Male	57 Participants n=101 Participants	54 Participants n=99 Participants	111 Participants n=200 Participants
Race/Ethnicity, Customized White	68 Participants n=91 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.	73 Participants n=93 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.	141 Participants n=184 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.
Race/Ethnicity, Customized Black	18 Participants n=91 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.	16 Participants n=93 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.	34 Participants n=184 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.
Race/Ethnicity, Customized Asian	5 Participants n=91 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.	3 Participants n=93 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.	8 Participants n=184 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.
Race/Ethnicity, Customized More than one Race	0 Participants n=91 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.	1 Participants n=93 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.	1 Participants n=184 Participants • Excluded 10 patients in intervention arm and 6 patients in placebo arm who did not have race data available.
BMI, mean (SD)	28.8 kg/m^2 STANDARD_DEVIATION 10.1 • n=101 Participants	27.9 kg/m^2 STANDARD_DEVIATION 8.4 • n=99 Participants	28.3 kg/m^2 STANDARD_DEVIATION 9.3 • n=200 Participants
Medical History, # with Malignancy	26 Participants n=101 Participants	32 Participants n=99 Participants	58 Participants n=200 Participants
Medical History, # with Coronary Artery Disease	26 Participants n=101 Participants	26 Participants n=99 Participants	52 Participants n=200 Participants
Medical History, # with Congestive Heart Failure	14 Participants n=101 Participants	23 Participants n=99 Participants	37 Participants n=200 Participants
Medical History, Liver Disease	11 Participants n=101 Participants	7 Participants n=99 Participants	18 Participants n=200 Participants
Primary Infectious Source Pneumonia	31 Participants n=94 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)	28 Participants n=93 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)	59 Participants n=187 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)
Primary Infectious Source Intra-abdominal	30 Participants n=94 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)	23 Participants n=93 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)	53 Participants n=187 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)
Primary Infectious Source Urinary Tract Infection	20 Participants n=94 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)	22 Participants n=93 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)	42 Participants n=187 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)
Primary Infectious Source Other	13 Participants n=94 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)	20 Participants n=93 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)	33 Participants n=187 Participants • Patients who did not have an identifiable primary infectious disease source were excluded from these tabulations (7 in intervention and 6 in placebo)
Volume of Intravenous Fluids Prior to Study Drug	2000 mL n=101 Participants	2000 mL n=99 Participants	2000 mL n=200 Participants
Time from Vasopressor Initiation to First Study Drug	14.5 hours n=101 Participants	13.0 hours n=99 Participants	13.5 hours n=200 Participants
Time from Informed Consent to First Study Drug	2.2 Hours n=101 Participants	2.0 Hours n=99 Participants	2.1 Hours n=200 Participants
Baseline Cardiovascular Component of Total SOFA Score	4 Units on a scale n=101 Participants	4 Units on a scale n=99 Participants	4 Units on a scale n=200 Participants
# on Mechanical Ventilation	48 Participants n=101 Participants	44 Participants n=99 Participants	92 Participants n=200 Participants
# with Acute Respiratory Distress Syndrome	22 Participants n=101 Participants	18 Participants n=99 Participants	40 Participants n=200 Participants
30 Day Predicted Survival High Likelihood	34 Participants n=101 Participants	38 Participants n=99 Participants	72 Participants n=200 Participants
30 Day Predicted Survival Uncertain	61 Participants n=101 Participants	54 Participants n=99 Participants	115 Participants n=200 Participants
30 Day Predicted Survival Low Likelihood	6 Participants n=101 Participants	7 Participants n=99 Participants	13 Participants n=200 Participants
Lactate	1.8 mmol/L n=101 Participants	1.8 mmol/L n=99 Participants	1.8 mmol/L n=200 Participants

PRIMARY outcome

Timeframe: Enrollment to 72-hours

Population: For the 72 hour SOFA score, patients who expired prior to that time point are excluded from the calculation of mean (SD) of the 72 hour SOFA score.

Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours. The SOFA score ranges from a minimum of 0 to a maximum of 24, with higher scores meaning worse outcomes.

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours Enrollment SOFA score	9.1 Units on a scale Standard Deviation 3.5	9.2 Units on a scale Standard Deviation 3.2
Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours 72 hour SOFA score	4.4 Units on a scale Standard Deviation 4.1	5.1 Units on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: Enrollment until 7-days or discharge from the ICU

Development of renal failure as defined by a Kidney Disease Improving Global Outcomes [KDIGO] stage 3 or higher. There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure).

Stage 1- serum creatinine 1.5 to 1.9 times baseline OR an increase in serum creatinine ≥ 0.3 mg/dL OR urine output < 0.5ml/kg/hour for 6-12 hours. Stage 2- serum creatinine 2.0-2.9 times baseline OR urine output <0.5mg/kg/hour for ≥ 12 hours Stage 3- serum creatinine 3.0 times baseline (or serum creatinine of more than or equal to 4.0 mg/dl with an acute increase of at least 0.5 mg/dl) (OR) Urine output less than 0.3 ml/kg/hour for 24 hours or anuria for 12 hours or new renal replacement therapy

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Renal Failure	32 Participants	27 Participants

SECONDARY outcome

Timeframe: Enrollment until 30-days after enrollment

Mortality rate

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
30-day Mortality	35 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Ventilator free days over the first 7-days after enrollment

Days not receiving invasive mechanical ventilation

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Ventilator Free Days	6 Days Interval 2.0 to 7.0	6 Days Interval 0.0 to 7.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Vasopressor free days over the first 7-days after enrollment

Days not receiving vasopressor

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Shock Free Days	5 Days Interval 3.0 to 5.0	4 Days Interval 1.0 to 5.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment until 28 days after enrollment

Number of days that the patient was not in the ICU. Timeframe listed below.

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
ICU Free Days	22 Days Interval 3.0 to 25.0	21 Days Interval 4.0 to 25.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment until hospital discharge, death, or 30-days. Whichever comes first.

Hospital mortality rate

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Hospital Mortality	28 Participants	23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment until ICU discharge, death, or 30-days. Whichever comes first.

ICU mortality rate

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Intensive Care Unit (ICU) Mortality	23 Participants	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: On day 3 (at approximately 72 hours) after the first study drug dose

Population: We were able to assess CAM-ICU delirium on day 3 in only 83 patients from treatment and 76 patients from the control arm (unable to assess for remaining patients due to death or discharge)

Describes if patient has delirium as defined by the Confusion Assessment Method (CAM)-ICU. The CAM-ICU method requires that the patient have 3 features to qualify for delirium:

1. Acute Onset of Changes or Fluctuations in the Course of Mental Status (AND )

2. Inattention (AND)

3. Disorganized thinking (OR) Altered Level of Consciousness

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=83 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=76 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Number of Participants With Delirium	31 Participants	35 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Enrollment until hospital discharge, death, or 30-days, whichever comes first.

Population: Population of patients who survived to hospital discharge. 73 patients in the treatment group and 76 patients in the control group survived to hospital discharge..

Home hospital disposition in patients who survive to discharge

Outcome measures

Measure	Vitamin C, Vitamin B1, Corticosteroids n=73 Participants The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=76 Participants Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Hospital Disposition: Survivors Discharged Home	34 Participants	35 Participants

Adverse Events

Vitamin C, Vitamin B1, Corticosteroids

Serious events: 13 serious events

Other events: 0 other events

Deaths: 35 deaths

Placebo

Serious events: 12 serious events

Other events: 0 other events

Deaths: 29 deaths

Serious adverse events

Measure	Vitamin C, Vitamin B1, Corticosteroids n=101 participants at risk The combination of vitamin C, vitamin B1, hydrocortisone : * Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days * Vitamin B1 (thiamine) 100mg every 6 hours x 4-days * Hydrocortisone 50mg every 6 hours x 4-days vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.	Placebo n=99 participants at risk Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Normal saline: Normal saline (0.9% NaCl solution) volume to match all components
Endocrine disorders Hyperglycemia	11.9% 12/101 • Number of events 101 • Time from enrollment to hospital discharge, an average of 13.5 days for all patients	7.1% 7/99 • Number of events 99 • Time from enrollment to hospital discharge, an average of 13.5 days for all patients
Metabolism and nutrition disorders Hypernatremia	10.9% 11/101 • Number of events 101 • Time from enrollment to hospital discharge, an average of 13.5 days for all patients	7.1% 7/99 • Number of events 99 • Time from enrollment to hospital discharge, an average of 13.5 days for all patients
Infections and infestations New Hospital Acquired Infection	12.9% 13/101 • Number of events 101 • Time from enrollment to hospital discharge, an average of 13.5 days for all patients	12.1% 12/99 • Number of events 99 • Time from enrollment to hospital discharge, an average of 13.5 days for all patients

Other adverse events

Adverse event data not reported

Additional Information

Michae Donnino

Beth Israel Deaconness Medical Center Emergency Department

Phone: (617) 754-2882

Email: mdonnino@bidmc.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place