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NCT Number: NCT05402826

Effect of Oral Zinc and Vitamin E Supplementation on Short-term Postoperative Outcomes 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.

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Key information

Conditions

Heart Surgery

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shafa Hospital, Kerman University of Medical Sciences

Kerman, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oral zinc + vitamin E

Dietary Supplement

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.

Placebo

Dietary Supplement

Patients in the placebo group will receive placebo pills before and after surgery.

Primary outcomes

  1. ICU LOS

    Time frame: Through study completion, an average of 5 days

    Duration of patients' stay in the intensive care unit

  2. Post surgery hospital LOS

    Time frame: Through study completion, an average of 10 days

    Duration of patients' stay in the hospital

Secondary outcomes

  1. The sequential organ failure assessment score

    Time frame: On the third day after surgery

    Higher scores mean a worse outcome.

  2. Plasma superoxide dismutase activity

    Time frame: up to 3 days after surgery

    Plasma superoxide dismutase activity in patients studied before surgery and three days after surgery

  3. Plasma total antioxidant

    Time frame: up to 3 days after surgery

    Plasma total antioxidant capacity in patients studied before surgery and three days after surgery

  4. Plasma CRP

    Time frame: up to 3 days after surgery

    Plasma C-reactive protein level in patients studied before surgery and three days after surgery

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University

Other

Collaborators

  • Kerman University of Medical Sciences

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 2, 2022
Registry last updated
Jan 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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