The Prognostic Impact of Selenium On Critical Surgical Patients
Primary Purpose
Critical Illness, Selenium Deficiency, Trace Element Deficiency
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Selenium Supplement
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness
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 inmunodeficiency 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
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Active Comparator
Placebo Comparator
Arm Label
low serum selenium with selenium supplement
low serum selenium with placebo supplement
non-low serum selenium with selenium supplement
non-low serum selenium with placebo supplement
Arm Description
Patients having low serum selenium with selenium supplement given
Patients having low serum selenium with placebo given
Patients having normal serum selenium with selenium supplement given
Patients having normal serum selenium with placebo given
Outcomes
Primary Outcome Measures
mortality rate
mortality rate in 30 days
Secondary Outcome Measures
hospital length
hospital length for current admission
ventilator length
ventilator length for current admission
complication rate
complication rate within 30 days
organ failure rate
organ failure rate within 30 days
Full Information
NCT ID
NCT04662242
First Posted
November 29, 2020
Last Updated
February 8, 2023
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04662242
Brief Title
The Prognostic Impact of Selenium On Critical Surgical Patients
Official Title
The Prognostic Impact of Selenium On Critical Surgical Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
November 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Selenium Deficiency, Trace Element Deficiency, Acute Abdomen, Sepsis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low serum selenium with selenium supplement
Arm Type
Experimental
Arm Description
Patients having low serum selenium with selenium supplement given
Arm Title
low serum selenium with placebo supplement
Arm Type
Placebo Comparator
Arm Description
Patients having low serum selenium with placebo given
Arm Title
non-low serum selenium with selenium supplement
Arm Type
Active Comparator
Arm Description
Patients having normal serum selenium with selenium supplement given
Arm Title
non-low serum selenium with placebo supplement
Arm Type
Placebo Comparator
Arm Description
Patients having normal serum selenium with placebo given
Intervention Type
Drug
Intervention Name(s)
Selenium Supplement
Other Intervention Name(s)
Zelnite
Intervention Description
Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
normal saline 100ml iv infusion for 7 days
Primary Outcome Measure Information:
Title
mortality rate
Description
mortality rate in 30 days
Time Frame
30 day
Secondary Outcome Measure Information:
Title
hospital length
Description
hospital length for current admission
Time Frame
1 year
Title
ventilator length
Description
ventilator length for current admission
Time Frame
1 year
Title
complication rate
Description
complication rate within 30 days
Time Frame
30 days
Title
organ failure rate
Description
organ failure rate within 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Tung Wu, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30348463
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.
Results Reference
background
PubMed Identifier
26214143
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.
Results Reference
background
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The Prognostic Impact of Selenium On Critical Surgical Patients
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