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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Drug: Control (Normal saline); Drug: Vitamin C

• Study Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
    • Contact: Hye Bin Kim; Phone Number: 82-2-2224-1242; Email: KAKDDUGI@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Participants in this group are administered IV normal saline.	Drug: Control (Normal saline); Participants in "Control group" are administered IV 100cc normal saline at the same timepoint as above.
Experimental: Vitamin C group; Participants in this group are administered IV vitamin C diluted in normal saline.	Drug: Vitamin 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.	5 minute after CPB cessation

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2020
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 20, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative acute kidney injury
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: 4-2019-1051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No