The Prognostic Impact of Selenium On Critical Surgical Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Prognostic Impact of Selenium On Critical Surgical Patients

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

Intervention / Treatment
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* Drug: Selenium Supplement
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low serum selenium with selenium supplement<br>Patients having low serum selenium with selenium supplement given | Drug: Selenium Supplement<br>* Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days<br>* Other names: Zelnite;|
| Placebo Comparator: low serum selenium with placebo supplement<br>Patients having low serum selenium with placebo given | Drug: normal saline<br>* normal saline 100ml iv infusion for 7 days<br>|
| Active Comparator: non-low serum selenium with selenium supplement<br>Patients having normal serum selenium with selenium supplement given | Drug: Selenium Supplement<br>* Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days<br>* Other names: Zelnite;|
| Placebo Comparator: non-low serum selenium with placebo supplement<br>Patients having normal serum selenium with placebo given | Drug: normal saline<br>* normal saline 100ml iv infusion for 7 days<br>|

What is the study measuring?
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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 |