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

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04210453
• Other study ID #: 4-2019-1051
• Status: Recruiting
• Phase: Phase 4
• Start date: March 24, 2020
• Est. completion date: December 2022

Study information

• Verified date: March 2020
• Source: Yonsei University
• Contact: Hye Bin Kim
• Phone: 82-2-2224-1242
• Email: KAKDDUGI[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Wounds and Injuries

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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