Acute Kidney Injury
Conditions
Keywords
Postoperative acute kidney injury
Brief summary
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.
Interventions
DRUGVitamin C
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.
Participants in Control group are administered IV 100cc normal saline at the same timepoint as above.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
Intervention model description
Patients are divided into 2 groups, who are administered IV Vitamin C or who are administered IV normal saline.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 20 years and undergoing elective valvular heart surgery whose preoperative acute renal failure score is ≥3 (moderate to severe risk).
Exclusion criteria
* Emergency operation * Cardiogenic shock or ventricular-assist device (eg. ECMO, IABP) * Severe chronic kidney disease (GFR(CKD-EPI) \<30ml/min/1.73m2) * Patients with past history of gout or renal stone or hyperoxaluria or cystinuria * Hemolytic anemia due to pyruvate kinase deficiency or glucose-6-phosphate dehydrogenase deficiency * Sicklemia or thalassemia * Hemochromatosis * Allergy to disodium ethylenediamine-tetraacetate or ascorbic acid * Patients taking aspirin up to 3 days before surgery * Patients taking antiepileptic drug or fluphenazine or steroid * Patients taking vitamin C within a month of surgery * Pregnant or lactating women * Patients who cannot understand the informed consent (eg. Foreigner)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative acute kidney injury | Postoperative 7 days | Compare the incidence of postoperative acute kidney injury between the Vitamin C group and the control group according to KDIGO guideline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative oxidative stress and vascular injury(Comparing the serum concentration) | Before anesthetic induction (Baseline) | Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation. |
Countries
South Korea
Contacts
Primary ContactHye Bin Kim
Outcome results
None listed