Critical IllnessPhase 4NCT04662242
The Prognostic Impact of Selenium On Critical Surgical Patients
A Phase 4 study testing Selenium Supplement and normal saline in people with Critical Illness and Selenium Deficiency, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Critical Illness, Selenium Deficiency, Trace Element Deficiency
- What is being tested?
- Selenium Supplement and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2020to 16 Nov 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Selenium Supplement, normal saline
- Medical subject headings
- Critical Illness, Abdomen, Acute, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium SupplementDrug
Also called Zelnite
Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days
normal salineDrug
normal saline 100ml iv infusion for 7 days
| Study group | Role | What they receive |
|---|---|---|
| low serum selenium with selenium supplement | Experimental | Patients having low serum selenium with selenium supplement given Receives: Drug: Selenium Supplement |
| low serum selenium with placebo supplement | Placebo comparator | Patients having low serum selenium with placebo given Receives: Drug: normal saline |
| non-low serum selenium with selenium supplement | Active comparator | Patients having normal serum selenium with selenium supplement given Receives: Drug: Selenium Supplement |
| non-low serum selenium with placebo supplement | Placebo comparator | Patients having normal serum selenium with placebo given Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
mortality rate in 30 days
Measured: 30 day
Secondary outcomes (4)
hospital length
hospital length for current admission
Measured: 1 year
ventilator length
ventilator length for current admission
Measured: 1 year
complication rate
complication rate within 30 days
Measured: 30 days
organ failure rate
organ failure rate within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
- Study start1 Dec 2020
- Primary completion31 Oct 2022
- Study completion16 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Tung Wu, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04662242
- Sponsor's protocol ID
- 201902287A3A0
- Status last verified
- Feb 2023
- First submitted
- 29 Nov 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30348463Allingstrup 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.
PubMed 26214143
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Impact of Selenium On Critical Surgical Patients
- ClinicalTrials.gov ID
- NCT04662242
- Acronym / sponsor ID
- 201902287A3A0
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| low serum selenium with selenium supplement | Experimental | Drug: Selenium SupplementPatients having low serum selenium with selenium supplement given |
| low serum selenium with placebo supplement | Placebo comparator | Drug: normal salinePatients having low serum selenium with placebo given |
| non-low serum selenium with selenium supplement | Active comparator | Drug: Selenium SupplementPatients having normal serum selenium with selenium supplement given |
| non-low serum selenium with placebo supplement | Placebo comparator | Drug: normal salinePatients having normal serum selenium with placebo given |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium SupplementAlso: ZelniteZelnite 400mcg/day in normal saline 100ml iv infusion for 7 days | Drug | low serum selenium with selenium supplement, non-low serum selenium with selenium supplement |
| normal salinenormal saline 100ml iv infusion for 7 days | Drug | low serum selenium with placebo supplement, non-low serum selenium with placebo supplement |
Primary outcome
mortality rate
Time frame: 30 day
mortality rate in 30 days
4 secondary outcomes
hospital length
Time frame: 1 year
ventilator length
Time frame: 1 year
complication rate
Time frame: 30 days
organ failure rate
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 30348463Singer 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.
- Background: PubMed 26214143Allingstrup 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Tung Wu, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Selenium Supplement and normal saline in people with Critical Illness and Selenium Deficiency, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 30 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04662242, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.