Trial Outcomes & Findings for High Dose Vitamin C in Cardiac Surgery Patients (NCT NCT02762331)

Last Updated: 2019-06-24

Results Overview

Change in baseline inflammatory biomarkers including TNF-alpha, C-reactive protein, and interleukin-6 will be measured at 6, 24, and 48 hours following first administration of study drug.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

48 hours

Results posted on

2019-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Vitamin C Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours. Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients	Normal Saline Intravenous normal saline 50 mL every six hours for 48 hours Placebo: Placebo intervention
Overall Study STARTED	4	2
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

High Dose Vitamin C in Cardiac Surgery Patients

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 48 hours

Population: Samples were collected but not analyzed due to study termination. This study was terminated because the therapy was proven effective by larger studies.

Change in baseline inflammatory biomarkers including TNF-alpha, C-reactive protein, and interleukin-6 will be measured at 6, 24, and 48 hours following first administration of study drug.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 24 hours

Population: Samples were collected but not analyzed due to study termination. This study was terminated because the therapy was proven effective by larger studies.

Change in baseline urine concentrations for neutrophil gelatinase-associated lipocalin (NGAL) will be measured at 6 and 24 hours.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

Atrial fibrillation is a common complication of CABG surgery. We will monitor EKG status for development of atrial fibrillation for 48 hours post-op.

Outcome measures

Outcome measures
Measure	Vitamin C n=4 Participants Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours. Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients	Normal Saline n=2 Participants Intravenous normal saline 50 mL every six hours for 48 hours Placebo: Placebo intervention
Occurence of Atrial Fibrillation	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 48 hours

Population: Samples were collected but not analyzed due to study termination. This study was terminated because the therapy was proven effective by larger studies.

Change in baseline coagulation biomarkers including thrombomodulin, fibrinogen, platelets and clotting parameters from thromboelastography will be measured at 6, 24, and 48 hours following the first administration of the study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours

Population: Samples were collected but not analyzed due to study termination. This study was terminated because the therapy was proven effective by larger studies.

Change in baseline lipidomic biomarkers including free fatty acids, eicosanoids, 3-polyunsaturated fatty acid-derived lipid mediators, phospholipid substrates of cytosolic PLA2α, and isoprostanes will be measured at 6- and 24 hours following administration of the study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

We will assess for develop of renal calculi as a safety measure.

Outcome measures

Outcome measures
Measure	Vitamin C n=4 Participants Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours. Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients	Normal Saline n=2 Participants Intravenous normal saline 50 mL every six hours for 48 hours Placebo: Placebo intervention
Development of Renal Calculi	0 Participants	0 Participants

Adverse Events

Vitamin C

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Donald Brophy, PharmD

Virginia Commonwealth University

Phone: (804) 827-1455

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Vitamin C n=4 Participants Intravenous ascorbic acid 50 mg/kg in 50 mL normal saline every six hours for 48 hours. Ascorbic Acid: Comparing safety and efficacy of IV Vitamin C in CABG patients 4 subjects total Age: Between 32 and 72 1 Female 3 Male 1 Black or African American/Non-Hispanic 3 White/Non-Hispanic Region of enrollment: USA	Normal Saline n=2 Participants Intravenous normal saline 50 mL every six hours for 48 hours Placebo: Placebo intervention 2 subjects total Age: 50; 74 2 Males 2 White/Non-Hispanic Region of enrollment: USA	Total n=6 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
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants