Trial Outcomes & Findings for Ascorbic Acid (Vitamin C) Infusion in Human Sepsis (NCT NCT01434121)

Last Updated: 2018-02-01

Results Overview

There were no instances of arterial hypotension, vomiting, or tachycardia within the study population related to the study drug

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

during time of infusion- 96 hours from time of enrollment

Results posted on

2018-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	High Dose Ascorbic Acid Subject receives a high dose of infused Vitamin C Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo	Low Dose Ascorbic Acid Subject receives a low dose of infused Vitamin C Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo	Placebo Subject receives an infusion of saline Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo
Overall Study STARTED	8	8	8
Overall Study COMPLETED	8	8	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ascorbic Acid (Vitamin C) Infusion in Human Sepsis

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: during time of infusion- 96 hours from time of enrollment

There were no instances of arterial hypotension, vomiting, or tachycardia within the study population related to the study drug

Outcome measures

Outcome measures
Measure	High Dose Ascorbic Acid n=8 Participants Subject receives a high dose of infused Vitamin C Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo	Low Dose Ascorbic Acid n=8 Participants Subject receives a low dose of infused Vitamin C Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo	Placebo n=8 Participants Subject receives an infusion of saline Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo
Number of Patients Who Experienced Ascorbic Acid Infusion Related Arterial Hypotension, Vomiting, or Tachycardia in Septic Patients	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: subject will be followed until discharged from the ICU, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first

Population: Limited data were collected for this assessment due to study termination. These data are no longer available and the study team does not have IRB approval to retroactively analyze the results

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: subject will be followed until mechanical ventilation has been discontinued, the subject has deceased, or study duration has reached 28 days from time of enrollment, whichever is first

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: subject will be followed until discharged from the hospital, has deceased, or study duration has reached 28 days from time of enrollment, whichever is first

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: during time of infusion - 96 hours from time of enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: during time of infusion - 96 hours from time of enrollment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: during time of infusions - 96 hours from time of enrollment

Outcome measures

Outcome data not reported

Adverse Events

High Dose Ascorbic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Dose Ascorbic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 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 Commonweath University

Phone: 804-628-5710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	High Dose Ascorbic Acid n=8 Participants Subject receives a high dose of infused Vitamin C Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo	Low Dose Ascorbic Acid n=8 Participants Subject receives a low dose of infused Vitamin C Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo	Placebo n=8 Participants Subject receives an infusion of saline Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	13 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants