The Prognostic Impact of Selenium On Critical Surgical Patients

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Critical Illness; Acute Abdomen; Selenium Deficiency; Trace Element Deficiency
• Intervention / Treatment: Drug: Selenium Supplement; Drug: normal saline

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: low serum selenium with selenium supplement; Patients having low serum selenium with selenium supplement given	Drug: Selenium Supplement; Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days; Other Names: Zelnite
PLACEBO_COMPARATOR: low serum selenium with placebo supplement; Patients having low serum selenium with placebo given	Drug: normal saline; normal saline 100ml iv infusion for 7 days
ACTIVE_COMPARATOR: non-low serum selenium with selenium supplement; Patients having normal serum selenium with selenium supplement given	Drug: Selenium Supplement; Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days; Other Names: Zelnite
PLACEBO_COMPARATOR: non-low serum selenium with placebo supplement; Patients having normal serum selenium with placebo given	Drug: normal saline; normal saline 100ml iv infusion for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality rate	mortality rate in 30 days	30 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital length	hospital length for current admission	1 year
ventilator length	ventilator length for current admission	1 year
complication rate	complication rate within 30 days	30 days
organ failure rate	organ failure rate within 30 days	30 days

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Yu-Tung Wu, MD, Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2020
• Primary Completion (ACTUAL): October 31, 2022
• Study Completion (ACTUAL): November 16, 2022

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: December 4, 2020
• First Posted (ACTUAL): December 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Signs and Symptoms, Digestive; Abdominal Pain; Critical Illness; Abdomen, Acute; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Trace Elements; Micronutrients; Antioxidants; Selenium
• Other Study ID Numbers: 201902287A3A0

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