Trial Outcomes & Findings for Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury (NCT NCT02106975)

Results Overview

mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

170 participants

Primary outcome timeframe

96 hours

Results posted on

2019-10-15

Participant Flow

Participant milestones

Participant milestones
Measure	Ascorbic Acid 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Overall Study STARTED	84	83
Overall Study COMPLETED	59	44
Overall Study NOT COMPLETED	25	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Ascorbic Acid 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Overall Study Death	25	39

Baseline Characteristics

Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo	Total n=167 Participants Total of all reporting groups
Age, Continuous	54 years n=99 Participants	57 years n=107 Participants	56 years n=206 Participants
Sex: Female, Male Female	39 Participants n=99 Participants	38 Participants n=107 Participants	77 Participants n=206 Participants
Sex: Female, Male Male	45 Participants n=99 Participants	45 Participants n=107 Participants	90 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	2 Participants n=107 Participants	4 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	82 Participants n=99 Participants	81 Participants n=107 Participants	163 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Race (NIH/OMB) Black or African American	13 Participants n=99 Participants	19 Participants n=107 Participants	32 Participants n=206 Participants
Race (NIH/OMB) White	68 Participants n=99 Participants	60 Participants n=107 Participants	128 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	84 participants n=99 Participants	83 participants n=107 Participants	167 participants n=206 Participants

PRIMARY outcome

Timeframe: 96 hours

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Modified Change in Sequential Organ Failure Assessment (mSOFA) Score	-2.96 score on a scale Standard Deviation 4.20	-3.20 score on a scale Standard Deviation 3.30

PRIMARY outcome

Timeframe: up to 168 hours

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo 0 hours	109 µg/ml Standard Deviation 76	119 µg/ml Standard Deviation 67
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo 48 hours	80 µg/ml Standard Deviation 66	84 µg/ml Standard Deviation 52
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo 96 hours	56 µg/ml Standard Deviation 51	59 µg/ml Standard Deviation 52
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo 168 hours	54 µg/ml Standard Deviation 48	46 µg/ml Standard Deviation 33

PRIMARY outcome

Timeframe: Up to 168 hours

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo 0 hours	14 ng/ml Standard Deviation 11	14 ng/ml Standard Deviation 8
Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo 48 hours	15 ng/ml Standard Deviation 11	15 ng/ml Standard Deviation 10
Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo 96 hours	15 ng/ml Standard Deviation 10	15 ng/ml Standard Deviation 10
Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo 168 hours	14 ng/ml Standard Deviation 9	14 ng/ml Standard Deviation 9

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo. 0 hour	11 Index Standard Deviation 10	10 Index Standard Deviation 6
Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo. 48 hours	7 Index Standard Deviation 5	7 Index Standard Deviation 5
Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo. 96 hours	9 Index Standard Deviation 6	7 Index Standard Deviation 8
Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo. 168 hours	8 Index Standard Deviation 8	8 Index Standard Deviation 6

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Estimate of Shunt

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo 0 hour	127 mmMercury Standard Deviation 58	121 mmMercury Standard Deviation 60
VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo 48 hours	127 mmMercury Standard Deviation 63	123 mmMercury Standard Deviation 51
VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo 96 hours	127 mmMercury Standard Deviation 47	114 mmMercury Standard Deviation 46
VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo 168 hours	115 mmMercury Standard Deviation 54	131 mmMercury Standard Deviation 77

SECONDARY outcome

Timeframe: Up to hour 96

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
mSOFA Scores at Hours 0, 48, 96 0 hours	10 units on a scale Interval 7.0 to 12.0	10 units on a scale Interval 8.0 to 12.0
mSOFA Scores at Hours 0, 48, 96 48 hours	9 units on a scale Interval 5.0 to 12.0	8 units on a scale Interval 6.0 to 12.0
mSOFA Scores at Hours 0, 48, 96 96 hours	6 units on a scale Interval 4.0 to 10.0	6 units on a scale Interval 5.0 to 10.0

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Ascorbate Level at Hour 0, 48, 96, 168 0 hour	25 µM Standard Deviation 18	26 µM Standard Deviation 19
Ascorbate Level at Hour 0, 48, 96, 168 48 hours	301 µM Standard Deviation 355	24 µM Standard Deviation 16
Ascorbate Level at Hour 0, 48, 96, 168 96 hours	397 µM Standard Deviation 580	26 µM Standard Deviation 18
Ascorbate Level at Hour 0, 48, 96, 168 168 hours	90 µM Standard Deviation 145	28 µM Standard Deviation 19

SECONDARY outcome

Timeframe: Up to Day 28

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Ventilator Free Days to Day 28	13 days Standard Deviation 11	11 days Standard Deviation 11

SECONDARY outcome

Timeframe: Up to Day 28

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
ICU-free Days at Day 28	11 days Standard Deviation 10	8 days Standard Deviation 9

SECONDARY outcome

Timeframe: Up to Day 28

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
All Cause Mortality to Day 28	30 percentage of participants	46 percentage of participants

SECONDARY outcome

Timeframe: Up to Day 60

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Hospital-free Days at Day 60	23 days Standard Deviation 22	15 days Standard Deviation 21

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Procalcitonin at Study Hour 0, 48, 96, 168 0 hour	12 ng/ml Standard Deviation 23	27 ng/ml Standard Deviation 69
Procalcitonin at Study Hour 0, 48, 96, 168 48 hours	7 ng/ml Standard Deviation 18	9 ng/ml Standard Deviation 20
Procalcitonin at Study Hour 0, 48, 96, 168 96 hours	3 ng/ml Standard Deviation 6	4 ng/ml Standard Deviation 9
Procalcitonin at Study Hour 0, 48, 96, 168 168 hours	2 ng/ml Standard Deviation 3	3 ng/ml Standard Deviation 11

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168 168 hours	3 ng/ml Standard Deviation 2	2 ng/ml Standard Deviation 2
Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168 0 hour	6 ng/ml Standard Deviation 5	7 ng/ml Standard Deviation 5
Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168 48 hours	4 ng/ml Standard Deviation 4	4 ng/ml Standard Deviation 3
Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168 96 hours	4 ng/ml Standard Deviation 3	3 ng/ml Standard Deviation 2

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168 0 hour	46 ng/ml Standard Deviation 35	43 ng/ml Standard Deviation 28
Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168 48 hours	42 ng/ml Standard Deviation 31	42 ng/ml Standard Deviation 33
Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168 96 hours	42 ng/ml Standard Deviation 27	44 ng/ml Standard Deviation 28
Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168 168 hours	44 ng/ml Standard Deviation 34	42 ng/ml Standard Deviation 31

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Oxygenation as measure by the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2). Scores range from 100 to 300 with lower values indicating more worse outcomes

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Oxygenation Score: Pressure 0 hour	189 mm Mercury Standard Deviation 96	214 mm Mercury Standard Deviation 183
Oxygenation Score: Pressure 48 hours	233 mm Mercury Standard Deviation 115	246 mm Mercury Standard Deviation 105
Oxygenation Score: Pressure 96 hours	226 mm Mercury Standard Deviation 109	244 mm Mercury Standard Deviation 122
Oxygenation Score: Pressure 168 hours	233 mm Mercury Standard Deviation 134	254 mm Mercury Standard Deviation 145

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Oxygenation as measure by the ratio of arterial oxygen saturation to fraction of inspired oxygen SpO2/FiO2

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Oxygenation Score: Saturation 0 hour	168 Ratio Standard Deviation 51	177 Ratio Standard Deviation 106
Oxygenation Score: Saturation 48 hours	231 Ratio Standard Deviation 81	220 Ratio Standard Deviation 75
Oxygenation Score: Saturation 96 hours	250 Ratio Standard Deviation 101	244 Ratio Standard Deviation 88
Oxygenation Score: Saturation 168 hours	268 Ratio Standard Deviation 107	299 Ratio Standard Deviation 115

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Coagulation as measured by Platelets per unit of blood. Scores range from less than 20 to more than 150. Lower scores indicate worse outcomes

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Coagulation 0 hour	173 Platelets/uL of Blood Standard Deviation 123	175 Platelets/uL of Blood Standard Deviation 142
Coagulation 48 hours	171 Platelets/uL of Blood Standard Deviation 133	147 Platelets/uL of Blood Standard Deviation 115
Coagulation 96 hours	182 Platelets/uL of Blood Standard Deviation 141	165 Platelets/uL of Blood Standard Deviation 119
Coagulation 168 hours	226 Platelets/uL of Blood Standard Deviation 180	228 Platelets/uL of Blood Standard Deviation 127

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Liver function as measured by Total Bilirubin. Normal levels range from 0.2 - 1.2. Levels greater than 1.2 indicate worse outcomes

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Liver Function 0 hour	1 Mg/dL Interval 0.0 to 22.0	1 Mg/dL Interval 0.0 to 24.0
Liver Function 48 hours	1 Mg/dL Interval 0.0 to 23.0	1 Mg/dL Interval 0.0 to 20.0
Liver Function 96 hours	1 Mg/dL Interval 0.0 to 22.0	1 Mg/dL Interval 0.0 to 18.0
Liver Function 168 hours	1 Mg/dL Interval 0.0 to 28.0	1 Mg/dL Interval 0.0 to 21.0

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Cardiovascular function as measured by Mean arterial pressure. Scores less than 70 mmHg indicate worse outcomes.

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Cardiovascular Function 0 hour	73 mmHg Standard Deviation 13	73 mmHg Standard Deviation 10
Cardiovascular Function 48 hours	78 mmHg Standard Deviation 15	79 mmHg Standard Deviation 14
Cardiovascular Function 96 hours	84 mmHg Standard Deviation 16	84 mmHg Standard Deviation 16
Cardiovascular Function 168 hours	81 mmHg Standard Deviation 14	83 mmHg Standard Deviation 17

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

State of consciousness as measure by Glasgow Coma Scale which gives a score based on eye, verbal, and motor responses. Scores range from 3 to 15 with lower scores indicating worse outcome

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
State of Consciousness 168 hours	10 units on a scale Interval 3.0 to 15.0	12 units on a scale Interval 3.0 to 15.0
State of Consciousness 0 hour	8 units on a scale Interval 2.0 to 15.0	7 units on a scale Interval 3.0 to 15.0
State of Consciousness 48 hours	9 units on a scale Interval 3.0 to 15.0	9 units on a scale Interval 3.0 to 15.0
State of Consciousness 96 hours	10 units on a scale Interval 3.0 to 15.0	10 units on a scale Interval 3.0 to 15.0

SECONDARY outcome

Timeframe: Up to hour 168

Population: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Renal function as measured by Creatinine. Scores range from less than 1.2 to greater than 5.0 with higher scores indicating worse outcomes

Outcome measures

Outcome measures
Measure	Ascorbic Acid n=84 Participants 200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Ascorbic Acid: Intervention	5% Dextrose in Water n=83 Participants 50ml every 6 hours for 96 hours Placebo: 5% Dextrose in water: Placebo
Renal Function 0 hour	1 Mg/dL Interval 0.0 to 6.0	2 Mg/dL Interval 0.0 to 7.0
Renal Function 48 hours	2 Mg/dL Interval 0.0 to 8.0	1 Mg/dL Interval 0.0 to 6.0
Renal Function 96 hours	1 Mg/dL Interval 0.0 to 7.0	1 Mg/dL Interval 0.0 to 5.0
Renal Function 168 hours	1 Mg/dL Interval 0.0 to 7.0	1 Mg/dL Interval 0.0 to 6.0

Adverse Events

Ascorbic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 25 deaths

5% Dextrose in Water

Serious events: 0 serious events

Other events: 0 other events

Deaths: 38 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alpha A Fowler, III, MD

Virginia Commonwealth University School of Medicine

Phone: 804-828-9071

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place