Acute Kidney InjuryPhase 4NCT04210453
The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
A Phase 4 study testing Vitamin C in people with Acute Kidney Injury, run by Yonsei University at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Vitamin C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Mar 2020to Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 20 years and undergoing elective valvular heart surgery whose preoperative acute renal failure score is ≥3 (moderate to severe risk).
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine
Seoul
Hye Bin Kim, 82-2-2224-1242, KAKDDUGI@yuhs.ac
About this study
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.
- Conditions
- Acute Kidney Injury
- Being tested
- Vitamin C, Control (Normal saline)
- Keywords
- Postoperative acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Control (Normal saline)Drug
Participants in "Control group" are administered IV 100cc normal saline at the same timepoint as above.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Participants in this group are administered IV normal saline. Receives: Drug: Control (Normal saline) |
| Vitamin C group | Experimental | Participants in this group are administered IV vitamin C diluted in normal saline. Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative 7 days
Secondary outcomes (2)
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.
Measured: 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.
Measured: 5 minute after CPB cessation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start24 Mar 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are divided into 2 groups, who are administered IV Vitamin C or who are administered IV normal saline.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210453
- Sponsor's protocol ID
- 4-2019-1051
- Status last verified
- Mar 2020
- First submitted
- 12 Dec 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
- ClinicalTrials.gov ID
- NCT04210453
- Acronym / sponsor ID
- 4-2019-1051
- Conditions
- Acute Kidney Injury
- Keywords
- Postoperative acute kidney injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are divided into 2 groups, who are administered IV Vitamin C or who are administered IV normal saline.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Control (Normal saline)Participants in this group are administered IV normal saline. |
| Vitamin C group | Experimental | Drug: Vitamin CParticipants in this group are administered IV vitamin C diluted in normal saline. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 20 years and undergoing elective valvular heart surgery whose preoperative acute renal failure score is ≥3 (moderate to severe risk).
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CParticipants 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. | Drug | Vitamin C group |
| Control (Normal saline)Participants in "Control group" are administered IV 100cc normal saline at the same timepoint as above. | Drug | Control group |
Primary outcome
Postoperative acute kidney injury
Time frame: Postoperative 7 days
Compare the incidence of postoperative acute kidney injury between the Vitamin C group and the control group according to KDIGO guideline.
2 secondary outcomes
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
Time frame: Before anesthetic induction (Baseline)
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
Time frame: 5 minute after CPB cessation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin C in people with Acute Kidney Injury, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hye Bin Kim (82-2-2224-1242, KAKDDUGI@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative acute kidney injury (time frame: Postoperative 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.