Trial Outcomes & Findings for High Dose Intravenous Ascorbic Acid in Severe Sepsis (NCT NCT02734147)
NCT ID: NCT02734147
Last Updated: 2021-02-16
Results Overview
Sequential Organ Failure Assessment (SOFA) Score included the degree of dysfunction of six organ systems (Respiratory, Cardiovascular, Liver, Renal, Coagulation, Neurologic. A modification of the SOFA includes the exclusion of the Liver function. Total score is reported, minimum score = 0 maximum score = 20. Higher scores indicate greater degree of dysfunction.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline and 72 hours
Results posted on
2021-02-16
Participant Flow
Participant milestones
| Measure |
High Dose IV Ascorbic Acid
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
Participant Started: 12 Participant Completed: 9
|
Placebo
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
Participant Started: 12 Participant Completed: 11
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Dose IV Ascorbic Acid
n=12 Participants
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 Participants
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
11 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
13 Participants
n=24 Participants
|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 13.6 • n=12 Participants
|
70.2 years
STANDARD_DEVIATION 14.4 • n=12 Participants
|
68.9 years
STANDARD_DEVIATION 13.8 • n=24 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
8 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
16 Participants
n=24 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
12 participants
n=12 Participants
|
24 participants
n=24 Participants
|
|
Ascorbic Acid Concentration, Baseline
|
0.3 mg/dL
STANDARD_DEVIATION 0.3 • n=11 Participants • Missing Data
|
0.4 mg/dL
STANDARD_DEVIATION 0.3 • n=11 Participants • Missing Data
|
0.3 mg/dL
STANDARD_DEVIATION 0.3 • n=22 Participants • Missing Data
|
|
Ascorbic Acid Concentrations <0.4 mg/dL, Baseline
|
72.7 percentage of participants
n=11 Participants • Missing data
|
36.6 percentage of participants
n=11 Participants • Missing data
|
68.1 percentage of participants
n=22 Participants • Missing data
|
|
PIRO Score, Baseline
|
15.4 scores on a scale
STANDARD_DEVIATION 3.9 • n=12 Participants
|
15.9 scores on a scale
STANDARD_DEVIATION 4.0 • n=12 Participants
|
15.7 scores on a scale
STANDARD_DEVIATION 3.9 • n=24 Participants
|
|
Modified SOFA Score, Baseline
|
5.2 units on a scale
STANDARD_DEVIATION 2.5 • n=12 Participants
|
5.0 units on a scale
STANDARD_DEVIATION 2.3 • n=12 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 2.3 • n=24 Participants
|
|
ICU Admission
|
5 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
10 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline and 72 hoursPopulation: Data was not available for 3 participants in the treatment group.
Sequential Organ Failure Assessment (SOFA) Score included the degree of dysfunction of six organ systems (Respiratory, Cardiovascular, Liver, Renal, Coagulation, Neurologic. A modification of the SOFA includes the exclusion of the Liver function. Total score is reported, minimum score = 0 maximum score = 20. Higher scores indicate greater degree of dysfunction.
Outcome measures
| Measure |
High Dose IV Ascorbic Acid
n=9 Participants
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 Participants
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
Change in Modified SOFA Score
|
-1.0 units on a scale
Standard Deviation 4.4
|
-1.75 units on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: at 72 HoursPopulation: Data was not available for 3 participants in the treatment group.
Sequential Organ Failure Assessment (SOFA) Score included the degree of dysfunction of six organ systems (Respiratory, Cardiovascular, Liver, Renal, Coagulation, Neurologic. A modification of the SOFA includes the exclusion of the Liver function. Total score is reported, minimum score = 0 maximum score = 20. Higher scores indicate greater dysfunction.
Outcome measures
| Measure |
High Dose IV Ascorbic Acid
n=9 Participants
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 Participants
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
Modified SOFA Score
|
4.1 units on a scale
Standard Deviation 4.8
|
3.3 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: 32 HoursAscorbic Acid Concentration Normal Ascorbic Acid Range 0.4-2.0 mg/dL
Outcome measures
| Measure |
High Dose IV Ascorbic Acid
n=12 Participants
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 Participants
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
Ascorbic Acid Concentration at 32 Hours
|
13.8 mg/dL
Standard Deviation 10.9
|
0.22 mg/dL
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Length of ICU stay up to 200 hoursPopulation: Data was not available for 7 participants in both groups.
ICU Length of Stay in Hours
Outcome measures
| Measure |
High Dose IV Ascorbic Acid
n=5 Participants
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=5 Participants
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
ICU Length of Stay
|
29 Hours
Interval 6.0 to 187.0
|
47 Hours
Interval 39.0 to 144.0
|
SECONDARY outcome
Timeframe: From ICU admission through ICU discharge, up to 2 weeksFrom admission until discharge from ICU in days
Outcome measures
| Measure |
High Dose IV Ascorbic Acid
n=12 Participants
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 Participants
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
Hospital Length of Stay
|
7 Days
Interval 5.0 to 9.0
|
6 Days
Interval 4.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline and 72 hoursPopulation: Data was not available for 3 participants in the treatment group.
PIRO consists of 4 assessments, Predisposition (scored 0-9), Infection (scored 0-4), Response (scored 0-6), and Organ Failure (scored 0-14) (PIRO). The total PIRO score is the sum of all subscores and ranges from 0-33 with higher scores indicating worse health.
Outcome measures
| Measure |
High Dose IV Ascorbic Acid
n=9 Participants
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 Participants
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
Change in PIRO Score
|
-3.7 units on a scale
Standard Deviation 3
|
-4.5 units on a scale
Standard Deviation 3.9
|
SECONDARY outcome
Timeframe: From initial hospital admission through discharge, up to 2 weeks.Outcome measures
| Measure |
High Dose IV Ascorbic Acid
n=12 Participants
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 Participants
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
Percentage of Participants Who Died
|
16.7 Percentage of participants
|
16.7 Percentage of participants
|
Adverse Events
High Dose IV Ascorbic Acid
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Placebo
Serious events: 2 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
High Dose IV Ascorbic Acid
n=12 participants at risk
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 participants at risk
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
General disorders
Death
|
16.7%
2/12 • 2 weeks
|
16.7%
2/12 • 2 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/12 • 2 weeks
|
8.3%
1/12 • 2 weeks
|
Other adverse events
| Measure |
High Dose IV Ascorbic Acid
n=12 participants at risk
Patients will receive 67 mg/kg IV ascorbic acid in 100 ml normal saline over 30 minutes every 8 hours (200 mg/kg/day) for 72 hours.
Ascorbic Acid
|
Placebo
n=12 participants at risk
The placebo group will receive 100 ml 0.9% NaCl over 30 minutes every 8 hours for 72 hours.
Normal Saline
|
|---|---|---|
|
Vascular disorders
Hypotension (SBP< 90)
|
16.7%
2/12 • Number of events 3 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
|
Cardiac disorders
Tachycardia (HR increase 20 bpm)
|
8.3%
1/12 • Number of events 2 • 2 weeks
|
16.7%
2/12 • Number of events 2 • 2 weeks
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 3 • 2 weeks
|
0.00%
0/12 • 2 weeks
|
|
General disorders
Other
|
33.3%
4/12 • Number of events 8 • 2 weeks
|
25.0%
3/12 • Number of events 5 • 2 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place