The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Acute Kidney Injury

Treatments: Drug: Control (Normal saline); Drug: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT04210453

4-2019-1051

Details and patient eligibility

About

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.

Enrollment: 264 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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264 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Participants in this group are administered IV normal saline.

Treatment:

Drug: Control (Normal saline)

Vitamin C group

Experimental group

Description:

Participants in this group are administered IV vitamin C diluted in normal saline.

Treatment:

Drug: Vitamin C