Reperfusion Injury
Conditions
Keywords
Free Radicals, Ascorbic Acid, Cardiac Surgery, Prevention of Reperfusion Injury
Brief summary
It has been shown that the stress that occurs during cardiac surgery leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to complications after surgery. This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the outcome and complications after cardiac surgery.
Detailed description
Patients undergoing cardiac surgery are at significant risk for multiple major complications beyond those associated with other major operations. Most patients survive these events, but up to 10% develop injury to organ systems including the kidneys, lungs, pancreas, brain, etc. It has been shown that the stress that occurs during this critical period (cardiac surgery) leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which seem to contribute to these complications. This study will investigate the effects of high doses of intravenous (IV) Vitamin C administered before, during and after the cardiac surgery.
Interventions
DRUGAscorbic Acid
Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.
OTHER5 % Dextrose Water or Normal Saline
100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients 18 years or older undergoing elective or urgent (prior to hospital discharge) cardiac surgery.
Exclusion criteria
* History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate dehydrogenase deficiency) or the chronic use of steroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 30 days | Number of patients who expire within 30 days of their surgery (both in patients and discharged patients) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Insufficiency | hospital discharge | The number of patients who develop renal insufficiency during hospitalization. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from Oct. 31, 2007 thru July 22, 2009 in the Cardiothoracic Surgery Clinic.
Participants by arm
| Arm | Count |
|---|---|
| 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 x 48 hours. | 28 |
| B-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. | 29 |
| Total | 57 |
Baseline characteristics
| Characteristic | A-Ascorbic Acid (Vitamin C) | Total | B-Placebo |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 28 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 29 Participants | 17 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 2 | 67 years STANDARD_DEVIATION 2 | 65 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 28 participants | 57 participants | 29 participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 21 Participants | 44 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 0 / 28 | 0 / 29 |
| serious Total, serious adverse events | 0 / 28 | 0 / 29 |
Outcome results
Primary
Mortality
Number of patients who expire within 30 days of their surgery (both in patients and discharged patients)
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| A-Ascorbic Acid (Vitamin C) | Mortality | 0 participants |
| B-Placebo | Mortality | 0 participants |
Secondary
Renal Insufficiency
The number of patients who develop renal insufficiency during hospitalization.
Time frame: 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