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

Phase 4

• Conditions: Acute Kidney Injury
• Interventions: Drug: Control (Normal saline); Drug: Vitamin C

• Registration Number: NCT04210453
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-24
• Status Verified: 2020-03
• Study Start: 2020-03-24
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-26
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 264

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control (Normal saline)	Participants in this group are administered IV normal saline.
Vitamin C group	Vitamin C	Participants in this group are administered IV vitamin C diluted in normal saline.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)	5 minute after CPB cessation	Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of