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

Sponsor

Yonsei University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04210453

Collaborator

(none)

264

Enrollment

Location

Arms

32.3

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Kidney Injury	Drug: Vitamin C Drug: Control (Normal saline)	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

264 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

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

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Mar 24, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Postoperative oxidative stress and vascular injury(Comparing the serum concentration) [Before anesthetic induction (Baseline)]
Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT04210453

Other Study ID Numbers:

4-2019-1051

First Posted:

Dec 24, 2019

Last Update Posted:

Mar 26, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yonsei University

Postoperative acute kidney injury

Additional relevant MeSH terms:

Acute Kidney Injury

Wounds and Injuries

Ascorbic Acid

Study Results

No Results Posted as of Mar 26, 2020