Clinical trial NCT05402826: Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes in Cardiac Surgery Patients.
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Surgery
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: Kerman University of Medical Sciences
First posted: 2022-06-02
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: ICU LOS
timeFrame: Through study completion, an average of 5 days
measure: Post surgery hospital LOS
timeFrame: Through study completion, an average of 10 days
Secondary outcomes:
measure: The sequential organ failure assessment score
timeFrame: On the third day after surgery
measure: Plasma superoxide dismutase activity
timeFrame: up to 3 days after surgery
measure: Plasma total antioxidant
timeFrame: up to 3 days after surgery
measure: Plasma CRP
timeFrame: up to 3 days after surgery
Other outcomes:
Locations:
city: Kerman
country: Iran, Islamic Republic of
facility: Shafa Hospital, Kerman University of Medical Sciences
Study officials:
References: