Heart Surgery
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOral 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.
DIETARY_SUPPLEMENTPlacebo
Patients in the placebo group will receive placebo pills before and after surgery.
Sponsors
Kerman University of Medical Sciences
Shahid Beheshti University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| The sequential organ failure assessment score | On the third day after surgery | Higher scores mean a worse outcome. |
| 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 total antioxidant | up to 3 days after surgery | Plasma total antioxidant capacity 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 |
Countries
Iran
Outcome results
None listed