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In cases of cardiac surgery or sepsis which cause inflammation, oxidative stress, endothelial injury and vasoplegia, serum vitamin C concentration is sharply decreased. The anti-inflammatory and anti-oxidant effects of vitamin C and the effects of reducing vasoconstrictor use have been demonstrated in patients with sepsis and septic shock, however, the foregoing effects have not been validated in patients undergoing cardiac surgery.
In this study, investigators investigate the effect of intravenous vitamin C on the incidence of acute renal injury after valvular heart surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Participants in this group are administered IV normal saline. |
|
| Vitamin C group | Experimental | Participants in this group are administered IV vitamin C diluted in normal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | Participants in "Vitamin C group" are administered IV vitamin C diluted in 100 cc normal saline 1 day before surgery, at rewarming during surgery, 3 hours after surgery, and every 6 hours thereafter until postoperative 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative acute kidney injury | Compare the incidence of postoperative acute kidney injury between the Vitamin C group and the control group according to KDIGO guideline. | Postoperative 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative oxidative stress and vascular injury(Comparing the serum concentration) | Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation. | Before anesthetic induction (Baseline) |
| Postoperative oxidative stress and vascular injury(Comparing the serum concentration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hye Bin Kim | Contact | 82-2-2224-1242 | KAKDDUGI@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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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Patients are divided into 2 groups, who are administered IV Vitamin C or who are administered IV normal saline.
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Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
| Control (Normal saline) | Drug | Participants in "Control group" are administered IV 100cc normal saline at the same timepoint as above. |
|
Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation. |
| 5 minute after CPB cessation |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |