The Prognostic Impact of Selenium On Critical Surgical Patients

Sepsis Clinical Trial

Official title:

The Prognostic Impact of Selenium On Critical Surgical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04662242
• Other study ID #: 201902287A3A0
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: November 16, 2022

Study information

• Verified date: February 2023
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 16, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdomen, Acute
• Acute Abdomen
• Critical Illness
• Selenium Deficiency
• Sepsis
• Trace Element Deficiency

Intervention

Drug:
• Selenium Supplement
Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days
• normal saline
normal saline 100ml iv infusion for 7 days

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rate	mortality rate in 30 days	30 day
Secondary	hospital length	hospital length for current admission	1 year
Secondary	ventilator length	ventilator length for current admission	1 year
Secondary	complication rate	complication rate within 30 days	30 days
Secondary	organ failure rate	organ failure rate within 30 days	30 days