SepsisPhase 2SEREALNCT01601938
Selenium Replacement and Serum Selenium Level in Severe Sepsis and Septic Shock Patients
A Phase 2 study testing selenium replacement in people with Sepsis and Shock, Septic, run by Gil Joon Suh at 1 site in South Korea.
Trial summary
This study will be performed to determine whether selenium replacement reduces 28-day mortality of severe sepsis and septic shock patients, and to investigate whether selenium replacement contributes differently to the mortality reduction of the patients according to their initial serum selenium level. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Shock, Septic
- What is being tested?
- selenium replacement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to May 2014
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older
- clinical diagnosis of severe sepsis or septic shock
Who cannot join
- pregnancy or breast feeding
- age younger than 18
- advanced directive state to withhold treatment
- known allergy to selenium
- CPR or death within 24 hours after the diagnosis of severe sepsis or septic shock
- advanced malignancy without further treatment plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Selenium Replacement on Prognosis of Severe Sepsis and Septic Shock Patients and Their Initial Serum Selenium Level: a Randomized, Double-blind Placebo Controlled Phase 2 Study
This study will be performed to determine whether selenium replacement reduces 28-day mortality of severe sepsis and septic shock patients, and to investigate whether selenium replacement contributes differently to the mortality reduction of the patients according to their initial serum selenium level.
Read the detailed description
This study is a single center, randomized, double-blind, placebo controlled trial.
After the diagnosis of severe sepsis and septic shock, enrolled patients will be randomized. Then, selenium or placebo will be intravenously administered to them for 7 days. Hemodynamic and laboratory data will be recorded for 7 days and additional serum samples will be obtained at 0, 24, 72, and 168 hours post-treatment and stored. Mortality will be observed for 28 days.
An interim analysis will be conducted by the independent data safety monitoring board.
Serum selenium levels will be measured from the stored serum samples after the study completion.
- Conditions
- Sepsis, Shock, Septic
- Being tested
- selenium replacement, Placebo
- Keywords
- Sepsis, Shock, Septic, Selenium, Survival
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selenium replacementDietary supplement
Also called Selenase T pro injectione
Selenium 500 mcg (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.
PlaceboDietary supplement
Also called Normal saline
placebo (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| Selenium | Experimental | 500 mcg of selenium (10mL) daily for 7 days Receives: Dietary Supplement: selenium replacement |
| Placebo | Placebo comparator | Placebo 10 mL (delivered from biosyn) for 7 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
All cause mortality occurs within 28 days.
Measured: 28 days
Secondary outcomes (11)
ICU length of stay
After 3 months from enrollment, the participant's ICU length of stay will be evaluated.
Measured: 3 months
Mortality at hospital discharge
After 3 months from enrollment, the participant's in hospital mortality will be evaluated.
Measured: 3 months
Development of the new infection
After 3 months from enrollment, the development of new infection of the participant during the hospitalization will be evaluated.
Measured: 3 months
Serum selenium level
After study completion, serum selenium level will be measured from stored samples. Then, we will investigate whether selenium replacement contributes differently to the mortality reduction of the enrolled patients according to their initial serum selenium level.
Measured: At 0, 24, 72, 168 hours post-enrollment
Ventilator days
After 3 months from enrollment, total numbers of ventilator days of the participant during the hospitalization will be evaluated.
Measured: 3 months
Renal replacement therapy days
After 3 months from enrollment, the days of renal replacement therapy of the participant during the hospitalization will be evaluated.
Measured: 3 months
Oxidative stress marker
After study completion, serum glutathione peroxidase, reduced glutathione, NADPH, and MDA will be measured from stored samples.
Measured: At 0, 24, 72, 168 hours post-enrollment
Changes in severity scores
APACHE II score, SOFA score, and SAPS II will be calculated at 1, 3, 7 days
Measured: 7 days
3-month mortality
Measured: 3 months post-enrollment
Inflammatory markers
After study completion, serum cytokines, CRP, and chemokines will be measured from stored samples.
Measured: At 0, 24, 72, 268 hours post-enrollment
Vasopressor days
Days of dopamine, norepinephrine, dobutamine, vasopressin, and epinephrine will be investigated
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startSep 2012
- Primary completionApr 2014 (estimated)
- Study completionMay 2014 (estimated)
Why it stopped: We failed to obtain study drugs from the company
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gil Joon Suh
- Sponsor type
- University, hospital or other
- Collaborators
- Biosyn, Boryung Pharmaceutical Co., Ltd
- Responsible party
- Sponsor-investigator, Gil Joon Suh, Seoul National University Hospital
- Investigators
- Gil Joon Suh, professor, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601938
- Sponsor's protocol ID
- SNUHEM-SEREAL-12-0001
- Acronym
- SEREAL
- Status last verified
- Mar 2016
- First submitted
- 15 May 2012
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Angstwurm MW, Engelmann L, Zimmermann T, Lehmann C, Spes CH, Abel P, Strauss R, Meier-Hellmann A, Insel R, Radke J, Schuttler J, Gartner R. Selenium in Intensive Care (SIC): results of a prospective randomized, placebo-controlled, multiple-center study in patients with severe systemic inflammatory response syndrome, sepsis, and septic shock. Crit Care Med. 2007 Jan;35(1):118-26. doi: 10.1097/01.CCM.0000251124.83436.0E.
PubMed 17095947Andrews PJ, Avenell A, Noble DW, Campbell MK, Croal BL, Simpson WG, Vale LD, Battison CG, Jenkinson DJ, Cook JA; Scottish Intensive care Glutamine or seleNium Evaluative Trial Trials Group. Randomised trial of glutamine, selenium, or both, to supplement parenteral nutrition for critically ill patients. BMJ. 2011 Mar 17;342:d1542. doi: 10.1136/bmj.d1542.
PubMed 21415104Forceville X, Laviolle B, Annane D, Vitoux D, Bleichner G, Korach JM, Cantais E, Georges H, Soubirou JL, Combes A, Bellissant E. Effects of high doses of selenium, as sodium selenite, in septic shock: a placebo-controlled, randomized, double-blind, phase II study. Crit Care. 2007;11(4):R73. doi: 10.1186/cc5960.
PubMed 17617901
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Selenium Replacement on Prognosis of Severe Sepsis and Septic Shock Patients and Their Initial Serum Selenium Level: a Randomized, Double-blind Placebo Controlled Phase 2 Study
- ClinicalTrials.gov ID
- NCT01601938
- Acronym / sponsor ID
- SEREAL / SNUHEM-SEREAL-12-0001
- Conditions
- Sepsis, Shock, Septic
- Keywords
- Sepsis, Shock, Septic, Selenium, Survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We failed to obtain study drugs from the company
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gil Joon SuhUniversity, hospital or other
- Collaborators
- Biosyn, Boryung Pharmaceutical Co., Ltd
- Study start
- Sep 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 18 May 2012 (estimated)
- 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.
This study will be performed to determine whether selenium replacement reduces 28-day mortality of severe sepsis and septic shock patients, and to investigate whether selenium replacement contributes differently to the mortality reduction of the patients according to their initial serum selenium level.
Detailed description
This study is a single center, randomized, double-blind, placebo controlled trial.
After the diagnosis of severe sepsis and septic shock, enrolled patients will be randomized. Then, selenium or placebo will be intravenously administered to them for 7 days. Hemodynamic and laboratory data will be recorded for 7 days and additional serum samples will be obtained at 0, 24, 72, and 168 hours post-treatment and stored. Mortality will be observed for 28 days.
An interim analysis will be conducted by the independent data safety monitoring board.
Serum selenium levels will be measured from the stored serum samples after the study completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selenium | Experimental | Dietary Supplement: selenium replacement500 mcg of selenium (10mL) daily for 7 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo 10 mL (delivered from biosyn) for 7 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 or older
- clinical diagnosis of severe sepsis or septic shock
Key exclusion criteria (6 listed)
- pregnancy or breast feeding
- age younger than 18
- advanced directive state to withhold treatment
- known allergy to selenium
- CPR or death within 24 hours after the diagnosis of severe sepsis or septic shock
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 replacementAlso: Selenase T pro injectioneSelenium 500 mcg (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days. | Dietary supplement | Selenium |
| PlaceboAlso: Normal salineplacebo (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days. | Dietary supplement | Placebo |
Primary outcome
28-day mortality
Time frame: 28 days
All cause mortality occurs within 28 days.
11 secondary outcomes
ICU length of stay
Time frame: 3 months
Mortality at hospital discharge
Time frame: 3 months
Development of the new infection
Time frame: 3 months
Serum selenium level
Time frame: At 0, 24, 72, 168 hours post-enrollment
Ventilator days
Time frame: 3 months
Renal replacement therapy days
Time frame: 3 months
Oxidative stress marker
Time frame: At 0, 24, 72, 168 hours post-enrollment
Changes in severity scores
Time frame: 7 days
3-month mortality
Time frame: 3 months post-enrollment
Inflammatory markers
Time frame: At 0, 24, 72, 268 hours post-enrollment
Vasopressor days
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
- Background: PubMed 17095947Angstwurm MW, Engelmann L, Zimmermann T, Lehmann C, Spes CH, Abel P, Strauss R, Meier-Hellmann A, Insel R, Radke J, Schuttler J, Gartner R. Selenium in Intensive Care (SIC): results of a prospective randomized, placebo-controlled, multiple-center study in patients with severe systemic inflammatory response syndrome, sepsis, and septic shock. Crit Care Med. 2007 Jan;35(1):118-26. doi: 10.1097/01.CCM.0000251124.83436.0E.
- Background: PubMed 21415104Andrews PJ, Avenell A, Noble DW, Campbell MK, Croal BL, Simpson WG, Vale LD, Battison CG, Jenkinson DJ, Cook JA; Scottish Intensive care Glutamine or seleNium Evaluative Trial Trials Group. Randomised trial of glutamine, selenium, or both, to supplement parenteral nutrition for critically ill patients. BMJ. 2011 Mar 17;342:d1542. doi: 10.1136/bmj.d1542.
- Background: PubMed 17617901Forceville X, Laviolle B, Annane D, Vitoux D, Bleichner G, Korach JM, Cantais E, Georges H, Soubirou JL, Combes A, Bellissant E. Effects of high doses of selenium, as sodium selenite, in septic shock: a placebo-controlled, randomized, double-blind, phase II study. Crit Care. 2007;11(4):R73. doi: 10.1186/cc5960.
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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.
Gil Joon Suh, professor principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing selenium replacement in people with Sepsis and Shock, Septic, run by Gil Joon Suh at 1 site in South Korea.
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 2 inclusion and 6 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: withdrawn, as of the sponsor's last update on 4 Mar 2016. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
28-day mortality (time frame: 28 days). 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 NCT01601938, which also lists 3 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 4 Mar 2016.