Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes in Cardiac Surgery Patients.
- Conditions
- Heart Surgery
- Interventions
- Dietary Supplement: Oral zinc + vitamin EDietary Supplement: Placebo
- Registration Number
- NCT05402826
- Lead Sponsor
- Shahid Beheshti University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
- Patients who are candidates for open heart surgery (coronary artery bypass grafting)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zinc+vitamin E supplements Oral zinc + vitamin E Patients will receive zinc tablets plus alpha-tocopherol. Placebo Placebo Patients will receive placebo pills.
- Primary Outcome Measures
Name Time Method ICU LOS Through study completion, an average of 5 days Duration of patients' stay in the intensive care unit
Post surgery hospital LOS Through study completion, an average of 10 days Duration of patients' stay in the hospital
- Secondary Outcome Measures
Name Time Method The sequential organ failure assessment score On the third day after surgery Higher scores mean a worse outcome.
Plasma total antioxidant up to 3 days after surgery Plasma total antioxidant capacity in patients studied before surgery and three days after surgery
Plasma superoxide dismutase activity up to 3 days after surgery Plasma superoxide dismutase activity in patients studied before surgery and three days after surgery
Plasma CRP up to 3 days after surgery Plasma C-reactive protein level in patients studied before surgery and three days after surgery
Trial Locations
- Locations (1)
Shafa Hospital, Kerman University of Medical Sciences
🇮🇷Kerman, Iran, Islamic Republic of