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Trial Outcomes & Findings for High Dose Vitamin C in the Critically Ill Patient (NCT NCT01587963)

NCT ID: NCT01587963

Last Updated: 2017-05-11

Results Overview

Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

30 days

Results posted on

2017-05-11

Participant Flow

Participant milestones

Participant milestones
Measure
Ascorbic Acid
Ascorbic Acid Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
Placebo
Ringers Lactate or Normal Saline Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.
Overall Study
STARTED
7
4
Overall Study
COMPLETED
6
4
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Dose Vitamin C in the Critically Ill Patient

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ascorbic Acid
n=7 Participants
Ascorbic Acid Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
Ringers Lactate or Normal Saline
n=4 Participants
Ringers Lactate or Normal Saline Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.
Total
n=11 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=93 Participants
3 Participants
n=4 Participants
9 Participants
n=27 Participants
Age, Categorical
>=65 years
1 Participants
n=93 Participants
1 Participants
n=4 Participants
2 Participants
n=27 Participants
Sex: Female, Male
Female
3 Participants
n=93 Participants
3 Participants
n=4 Participants
6 Participants
n=27 Participants
Sex: Female, Male
Male
4 Participants
n=93 Participants
1 Participants
n=4 Participants
5 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
1 Participants
n=4 Participants
1 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
n=93 Participants
3 Participants
n=4 Participants
10 Participants
n=27 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=93 Participants
0 Participants
n=4 Participants
2 Participants
n=27 Participants
Race (NIH/OMB)
White
5 Participants
n=93 Participants
4 Participants
n=4 Participants
9 Participants
n=27 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Region of Enrollment
United States
7 participants
n=93 Participants
4 participants
n=4 Participants
11 participants
n=27 Participants

PRIMARY outcome

Timeframe: 30 days

Population: Study terminated prior to data collection completion. No data analysis performed.

Given the grim prognosis of septic and hypovolemic shock, we aim to study the efficacy on an alternative treatment modality by implementing high dose vitamin C therapy in our patient population. Through previous investigations, especially research in the burn patient population, we expect that high dose vitamin C therapy will be beneficial to patients with hypovolemic or septic shock.

Outcome measures

Outcome data not reported

Adverse Events

Ascorbic Acid

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ringers Lactate or Normal Saline

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

Vincente Gracias

Rutgers RWJMS

Phone: 732-235-7920

Results disclosure agreements

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