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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Surgery
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Oral zinc + vitamin E

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Kerman, Iran, Islamic Republic of
    • Shafa Hospital, Kerman University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shahid Beheshti University
• Collaborators: Kerman University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Actual): December 26, 2022
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: May 21, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin E
• Other Study ID Numbers: 30285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No