The Prognostic Impact of Selenium On Critical Surgical Patients

NCT ID: NCT04662242

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-11-16

Brief Summary

Selenium is an important trace element for human for its multiple roles such as the antioxidant activity. Previous evidences showed that critically ill patients may benefit from selenium supplement but the dose and results are controversial.

Patients after operations for acute abdomen usually suffer from sepsis and stress. The aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see the impact on prognosis.

Detailed Description

Acute abdomen is a common surgical emergency and is often the result of peritonitis due to an acute inflammatory process within abdominal cavity. Many of the patients with acute abdomen have severe sepsis and are critically ill that require an emergency surgery.

The mortality rate of such patients are high because these patients usually have a profound pathophysiological dysregulation and multiple organ dysfunction. One of the mechanism of is the loss of anti-oxidative capacity of cells that fail to recover from ischemic-reperfusion injury.

Selenium is an important cofactor that participate in the antioxidant activity of glutathione peroxidase reaction. There are evidences that critically ill patients may benefit from selenium supplement by better outcome and less mortality but the dose and results are still heterogenous and inconclusive.

The aim of this study is to investigate the efficacy of selenium replacement in critical patients of acute abdomen, to see if there is a significant impact on prognosis, and to establish a clinical guide in the future.

Conditions

Critical Illness; Selenium Deficiency; Trace Element Deficiency; Acute Abdomen; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

low serum selenium with selenium supplement

Patients having low serum selenium with selenium supplement given

Group Type: EXPERIMENTAL

Selenium Supplement

Intervention Type: DRUG

Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days

low serum selenium with placebo supplement

Patients having low serum selenium with placebo given

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

normal saline 100ml iv infusion for 7 days

non-low serum selenium with selenium supplement

Patients having normal serum selenium with selenium supplement given

Group Type: ACTIVE_COMPARATOR

Selenium Supplement

Intervention Type: DRUG

Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days

non-low serum selenium with placebo supplement

Patients having normal serum selenium with placebo given

Group Type: PLACEBO_COMPARATOR

normal saline

Intervention Type: DRUG

normal saline 100ml iv infusion for 7 days

Interventions

Selenium Supplement

Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days

Intervention Type: DRUG

normal saline

normal saline 100ml iv infusion for 7 days

Intervention Type: DRUG

Other Intervention Names

Zelnite

Eligibility Criteria

Inclusion Criteria

• Intensive care unit (ICU) patients receiving abdominal surgeries for acute abdomen
• within 48 hours post-operatively
• stay in ICU for more than 48 hours
• meets sepsis criteria of Sepsis-3 (2016)

Exclusion Criteria

• liver cirrhosis Child-Pugh score B or C
• breastfeeding or pregnancy
• allergy yo selenium
• vegetative status or irreversible diseases with life-expectancy fewer than 28 days
• End-stage renal disease under dialysis
• Human immunodeficiency virus infection
• neutropenia not due to sepsis (granulocyte < 1000/mm3)
• Heart failure (New York Heart Association class III-IV) or recent myocardial infarction (within 6 weeks)
• post cardiopulmonary cerebral resuscitation within 4 weeks
• taking immunosuppressants
• receiving anti-cancer therapy
• signed do not resuscitation
• joined other clinical research

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yu-Tung Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

References

Singer P, Blaser AR, Berger MM, Alhazzani W, Calder PC, Casaer MP, Hiesmayr M, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Oczkowski S, Szczeklik W, Bischoff SC. ESPEN guideline on clinical nutrition in the intensive care unit. Clin Nutr. 2019 Feb;38(1):48-79. doi: 10.1016/j.clnu.2018.08.037. Epub 2018 Sep 29.

Reference Type: BACKGROUND

PMID: 30348463 (View on PubMed)

Allingstrup M, Afshari A. Selenium supplementation for critically ill adults. Cochrane Database Syst Rev. 2015 Jul 27;2015(7):CD003703. doi: 10.1002/14651858.CD003703.pub3.

Reference Type: BACKGROUND

PMID: 26214143 (View on PubMed)

Other Identifiers

201902287A3A0

Identifier Type: -

Identifier Source: org_study_id