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| Name | Class |
|---|---|
| Kerman University of Medical Sciences | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients will receive placebo pills. |
|
| Zinc+vitamin E supplements | Active Comparator | Patients will receive zinc tablets plus alpha-tocopherol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral zinc + vitamin E | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU LOS | Duration of patients' stay in the intensive care unit | Through study completion, an average of 5 days |
| Post surgery hospital LOS | Duration of patients' stay in the hospital | Through study completion, an average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| The sequential organ failure assessment score | Higher scores mean a worse outcome. | On the third day after surgery |
| Plasma superoxide dismutase activity | Plasma superoxide dismutase activity in patients studied before surgery and three days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shafa Hospital, Kerman University of Medical Sciences | Kerman | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37891226 | Derived | Makiabadi E, Nakhaeizadeh R, Soleimani M, Nasrollahzadeh J. Effects of perioperative vitamin E and zinc co-supplementation on systemic inflammation and length of stay following coronary artery bypass graft surgery: a randomized controlled trial. Eur J Clin Nutr. 2024 Feb;78(2):120-127. doi: 10.1038/s41430-023-01356-x. Epub 2023 Oct 27. |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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| Placebo | Dietary Supplement | Patients in the placebo group will receive placebo pills before and after surgery. |
|
| up to 3 days after surgery |
| Plasma total antioxidant | Plasma total antioxidant capacity in patients studied before surgery and three days after surgery | up to 3 days after surgery |
| Plasma CRP | Plasma C-reactive protein level in patients studied before surgery and three days after surgery | up to 3 days after surgery |
| D008670 |
| Metals |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |