A Phase 4 interventional study of Vitamin C and Control (Normal saline) in Acute Kidney Injury, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-03-26.
Sponsored by Yonsei University · Phase 4, Interventional, and Prevention
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 264 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.
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Exclusion Criteria:
Participants in this group are administered IV normal saline.
Drug: Control (Normal saline)
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.
Participants in "Control group" are administered IV 100cc normal saline at the same timepoint as above.
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.
Time frame: Postoperative 7 days
Postoperative oxidative stress and vascular injury(Comparing the serum concentration)
Compare the serum concentration of Malondialdehyde, Thrombomodulin before anesthetic induction and after CPB cessation.
Time frame: 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.
Time frame: 5 minute after CPB cessation
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Yonsei University