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Completed

NCT Number: NCT04662242

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selenium Supplement

Drug

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

Other names: Zelnite

normal saline

Drug

normal saline 100ml iv infusion for 7 days

Primary outcomes

  1. mortality rate

    Time frame: 30 day

    mortality rate in 30 days

Secondary outcomes

  1. hospital length

    Time frame: 1 year

    hospital length for current admission

  2. ventilator length

    Time frame: 1 year

    ventilator length for current admission

  3. complication rate

    Time frame: 30 days

    complication rate within 30 days

  4. organ failure rate

    Time frame: 30 days

    organ failure rate within 30 days

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2020
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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