Trial Outcomes & Findings for High Dose Vitamin C in the Critically Ill Patient (NCT 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=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=99 Participants	3 Participants n=107 Participants	9 Participants n=206 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	3 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Male	4 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=99 Participants	3 Participants n=107 Participants	10 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	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants	4 Participants n=107 Participants	9 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	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	7 participants n=99 Participants	4 participants n=107 Participants	11 participants n=206 Participants

PRIMARY outcome

Timeframe: 30 days

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

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

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place