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

Heart Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05402826
• Other study ID #: 30285
• Status: Completed
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: January 2023
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 3, 2023
• Est. primary completion date: December 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heart Surgery

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shafa Hospital, Kerman University of Medical Sciences	Kerman

Sponsors (2)

Lead Sponsor	Collaborator
Shahid Beheshti University	Kerman University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU LOS	Duration of patients' stay in the intensive care unit	Through study completion, an average of 5 days
Primary	Post surgery hospital LOS	Duration of patients' stay in the hospital	Through study completion, an average of 10 days
Secondary	The sequential organ failure assessment score	Higher scores mean a worse outcome.	On the third day after surgery
Secondary	Plasma superoxide dismutase activity	Plasma superoxide dismutase activity in patients studied before surgery and three days after surgery	up to 3 days after surgery
Secondary	Plasma total antioxidant	Plasma total antioxidant capacity in patients studied before surgery and three days after surgery	up to 3 days after surgery
Secondary	Plasma CRP	Plasma C-reactive protein level in patients studied before surgery and three days after surgery	up to 3 days after surgery