Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes in Cardiac Surgery Patients.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Co-administration of Zinc and Vitamin E Oral Supplements on Short-term Postoperative Outcomes and Plasma Concentrations of Oxidative Stress Biomarkers in Cardiac Surgery Patients

Conditions
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Heart Surgery

Intervention / Treatment
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* Dietary Supplement: Oral zinc + vitamin E
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are candidates for open heart surgery (coronary artery bypass grafting) Exclusion Criteria: Frequent use of multivitamin, zinc, vitamin E, vitamin C, omega-3 supplements over the past month Active cancer, chronic rheumatic disease, ESRD, liver cirrhosis, severe infection (WBC> 12000 mm3) before surgery Continued use of corticosteroids or NSAIDs for two weeks prior to admission (except A.S.A)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients will receive placebo pills. | Dietary Supplement: Placebo<br>* Patients in the placebo group will receive placebo pills before and after surgery.<br>|
| Active Comparator: Zinc+vitamin E supplements<br>Patients will receive zinc tablets plus alpha-tocopherol. | Dietary Supplement: Oral zinc + vitamin E<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |