Sepsis Clinical Trial
Official title:
The Prognostic Impact of Selenium On Critical Surgical Patients
Verified date | February 2023 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
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
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 |
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