NCT04210453

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

March 24, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

2.7 years

First QC Date

December 12, 2019

Last Update Submit

March 24, 2020

Conditions

Acute Kidney Injury

Keywords

Postoperative acute kidney injury

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Postoperative oxidative stress and vascular injury(Comparing the serum concentration)

    Before anesthetic induction (Baseline)

  • Postoperative oxidative stress and vascular injury(Comparing the serum concentration)

    5 minute after CPB cessation

Study Arms (2)

Control group

PLACEBO COMPARATOR

Participants in this group are administered IV normal saline.

Drug: Control (Normal saline)

Vitamin C group

EXPERIMENTAL

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

Drug: Vitamin C

Interventions

Vitamin CDRUG

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.

Vitamin C group
Control (Normal saline)DRUG

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

Control group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 20 years and undergoing elective valvular heart surgery whose preoperative acute renal failure score is ≥3 (moderate to severe risk).

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ascorbic AcidSaline Solution

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Hye Bin Kim

CONTACT

82-2-2224-1242KAKDDUGI@yuhs.ac

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Neither participants, all care providers, investigators nor outcomes assessors know the treatment allocations.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Patients are divided into 2 groups, who are administered IV Vitamin C or who are administered IV normal saline.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 24, 2019

Study Start

March 24, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 26, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)