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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-Ascorbic Acid (Vitamin C) | Active Comparator | 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. |
|
| B-5% Dextrose Water or Normal Saline | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ascorbic Acid | Drug | Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Number of patients who expire within 30 days of their surgery (both in patients and discharged patients) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Renal Insufficiency | The number of patients who develop renal insufficiency during hospitalization. | hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Spotnitz | Rutgers RWJMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | United States |
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Subjects were recruited from Oct. 31, 2007 thru July 22, 2009 in the Cardiothoracic Surgery Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | B-Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality | Number of patients who expire within 30 days of their surgery (both in patients and discharged patients) | Posted | Number | participants | 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A-Ascorbic Acid (Vitamin C) | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Spotnitz, MD | Rutgers RWJMS | 732-235-9806 | spotnitz@rwjms.rutgers.edu |
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| ID | Term |
|---|---|
| D015427 | Reperfusion Injury |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| 5 % Dextrose Water or Normal Saline | Other | 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours. |
|
|
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Renal Insufficiency | The number of patients who develop renal insufficiency during hospitalization. | The PI has left the institution, all efforts to locate the data have been exhausted and therefore no results are available to be reported" | Posted | No | hospital discharge |
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | B-5% Dextrose Water or Normal Saline | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |