Trial Outcomes & Findings for Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients (NCT NCT01167569)

Results Overview

Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

57 participants

Primary outcome timeframe

30 days

Results posted on

2020-10-19

Participant Flow

Subjects were recruited from Oct. 31, 2007 thru July 22, 2009 in the Cardiothoracic Surgery Clinic.

Participant milestones

Participant milestones
Measure	A-Ascorbic Acid (Vitamin C) Ascorbic Acid Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg every 4 hours x 48 hours.	B-5% Dextrose Water or Normal Saline (Placebo 5% Dextrose Water or Normal Saline (placebo) 5 % Dextrose Water or Normal Saline: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
Overall Study STARTED	28	29
Overall Study COMPLETED	27	27
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A-Ascorbic Acid (Vitamin C) n=28 Participants Ascorbic Acid Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.	B-Placebo n=29 Participants 5% Dextrose Water or Normal Saline (placebo) 5 % Dextrose Water or Normal Saline: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.	Total n=57 Participants Total of all reporting groups
Age, Continuous	69 years STANDARD_DEVIATION 2 • n=5 Participants	65 years STANDARD_DEVIATION 2 • n=7 Participants	67 years STANDARD_DEVIATION 2 • n=5 Participants
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	12 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Region of Enrollment United States	28 participants n=5 Participants	29 participants n=7 Participants	57 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)

Outcome measures

Outcome measures
Measure	A-Ascorbic Acid (Vitamin C) n=28 Participants Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours. Ascorbic Acid: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.	B-Placebo n=29 Participants 5% Dextrose Water or Normal Saline (placebo) x 2 in the operating room followed by 5 % Dextrose Water or NS (placebo) every 4 hours X 48 hours. 5 % Dextrose Water or Normal Saline: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
Mortality	0 participants	0 participants

SECONDARY outcome

Timeframe: hospital discharge

Population: The PI has left the institution, all efforts to locate the data have been exhausted and therefore no results are available to be reported"

The number of patients who develop renal insufficiency during hospitalization.

Outcome measures

Outcome data not reported

Adverse Events

A-Ascorbic Acid (Vitamin C)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B-5% Dextrose Water 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

Alan Spotnitz, MD

Rutgers RWJMS

Phone: 732-235-9806

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place