An interventional study of Oral zinc + vitamin E and Placebo in Heart Surgery, sponsored by Shahid Beheshti University. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-05.
Sponsored by Shahid Beheshti University · Not applicable, Interventional, and Supportive care
Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. Using antioxidants during perioperative period may help improve this condition. Vitamin E and zinc have antioxidant effects. In this study, the effects of oral co-administration of zinc and vitamin E supplements on short-term postoperative outcomes in cardiac surgery patients will be investigated.
Cardiac surgery is a life-saving invasive procedure that may often be associated with significant postoperative complications. Cardiac surgery can cause oxidative stress due to ischemia-reperfusion. This is a post-ischemic complication that occurs when blood circulation is restored and causes inflammation and oxidative damage. Cardiac surgery with reperfusion injury can adversely affect the prognosis. Thus, reducing the extend of reperfusion injury and its associated pathways can be considered an important clinical issue. Reducing oxidative stress and inflammation may play an important role in the outcomes of heart surgery. Using antioxidants in pre or post surgery may help improve this condition. Vitamin E is a well-known fat-soluble antioxidant that prevents lipid peroxidation. Zinc has several roles including antioxidant effects. Zinc acts as a cofactor for important enzymes that contribute to the proper functioning of the antioxidant defense system. In addition, the mineral is involved in reducing free radicals by inducing metallothionein synthesis and circulating zinc concentration decreases significantly after surgery. In this study, the effects of oral co-administration of zinc and vitamin E supplements shortly before and after surgery on short-term postoperative outcomes, plasma concentrations of biomarkers of oxidative stress and inflammation in patients will be investigated.
Shahid Beheshti University is the lead sponsor of 35 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive placebo pills.
Dietary Supplement: Placebo
Patients will receive zinc tablets plus alpha-tocopherol.
Dietary Supplement: Oral zinc + vitamin E
In the zinc + vitamin E supplementation group, patients will receive a cumulative dose of 120 mg of oral zinc supplementation plus a cumulative dose of 1200 IU of oral vitamin E before surgery. After surgery, from the second day to the end of the hospital stay, patients receive 30 mg of zinc supplement plus 200 units of vitamin E per day.
Patients in the placebo group will receive placebo pills before and after surgery.
ICU LOS
Duration of patients' stay in the intensive care unit
Time frame: Through study completion, an average of 5 days
Post surgery hospital LOS
Duration of patients' stay in the hospital
Time frame: Through study completion, an average of 10 days
The sequential organ failure assessment score
Higher scores mean a worse outcome.
Time frame: On the third day after surgery
Plasma superoxide dismutase activity
Plasma superoxide dismutase activity in patients studied before surgery and three days after surgery
Time frame: up to 3 days after surgery
Plasma total antioxidant
Plasma total antioxidant capacity in patients studied before surgery and three days after surgery
Time frame: up to 3 days after surgery
Plasma CRP
Plasma C-reactive protein level in patients studied before surgery and three days after surgery
Time frame: up to 3 days after surgery
Plan to share: No
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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Shahid Beheshti University