Acute Kidney Injury Clinical Trial
Official title:
The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
Verified date | March 2020 |
Source | Yonsei University |
Contact | Hye Bin Kim |
Phone | 82-2-2224-1242 |
KAKDDUGI[@]yuhs.ac | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 264 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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) | |
Secondary | Postoperative oxidative stress and vascular injury(Comparing the serum concentration) | Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation. | 5 minute after CPB cessation |
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