Clinical trial NCT04662242: The Prognostic Impact of Selenium On Critical Surgical Patients
Official title: The Prognostic Impact of Selenium On Critical Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Selenium Deficiency
Trace Element Deficiency
Acute Abdomen
Sepsis
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-12-10
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: mortality rate
timeFrame: 30 day
Secondary outcomes:
measure: hospital length
timeFrame: 1 year
measure: ventilator length
timeFrame: 1 year
measure: complication rate
timeFrame: 30 days
measure: organ failure rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Tung Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.