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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-24

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients are divided into 2 groups, who are administered IV Vitamin C or who are administered IV normal saline.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.

Study Groups

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Control group

Participants in this group are administered IV normal saline.

Group Type PLACEBO_COMPARATOR

Control (Normal saline)

Intervention Type DRUG

Participants in "Control group" are administered IV 100cc normal saline at the same timepoint as above.

Vitamin C group

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

Group Type EXPERIMENTAL

Vitamin C

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Control (Normal saline)

Participants in "Control group" are administered IV 100cc normal saline at the same timepoint as above.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No