Heart; Surgery, Heart, Functional Disturbance as ResultPhase 3NCT01141556
Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery
A Phase 3 study testing Selenase in people with Heart; Surgery, Heart, Functional Disturbance as Result and Self Efficacy, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
Trial summary
Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result, Self Efficacy
- What is being tested?
- Selenase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Dec 2010to Sep 2012
- Phase
- Phase 3
- 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
- written informed consent
- males and females age ≥ 18 years
- patients undergoing an elective heart surgery
- normal renal function (serum creatinine ≤ 200 μmol/l)
Who cannot join
- pregnancy
- lack of written concent
- emergency operation
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Departement of Anaesthesia and Intensive Care, University Hospital of Basel
Basel
Kantonsspital Luzern
Lucerne, Canton of Lucerne, 6016
Kantonsspital Luzern
Lucerne, 6016
About this study
Official title: Effects of High-dose Intravenous Selenium (Selenase®) on the Systemic Inflammatory Response Syndrome and Related Organ Dysfunction
Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality in critically ill patients. The aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.
Read the detailed description
Selenium is a essential micronutrient that is present in form of selenocysteine in many enzymes. Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality. Different studies showed that selenium supplementation had beneficial effects in critically ill patients with systemic inflammatory response syndrome (SIRS), reducing the rate of infectious complications and length of hospital stay.
Heart surgery is associated with a complex systemic inflammatory response and the extent correlates with the development of postoperative complications. Former clinical trials used selenium supplementation with a loading dose of normally 1000 to 2000 μg, followed by a daily dosage of 1000 μg. With these dosage regimes pharmacological investigations demonstrated a delayed increase of the selenium concentration in plasma and whole blood. As a result a delayed increase of selenoenzymes can be assumed.
Aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.
Primary endpoints are: Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score and the length of ICU stay in hours.
Secondary endpoints are: incidence of acute renal failure, total requirement of vasoconstrictors and fluid replacement therapy
Inclusion criteria: written informed consent, males and females age ≥ 18 years, patients undergoing an elective heart surgery, normal renal function (serum creatinine ≤ 200 μmol/l)
Exclusion criteria: pregnancy, lack of written concent, emergency operation
- Being tested
- Selenase
- Keywords
- selenium, clinical outcome, heart surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelenaseDrug
Also called Selenase: Selenium
After enrollment, patients will be prospectively randomized into two groups: a placebo group without selenium and a group receiving a loading dose of selenium 4000 μg intraoperatively,followed by a daily dosage of 1000 μg until leaving the ICU (longest supplementation 13 days).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (NaCl) i.v. intraoperatively, followed by an daily bolus of Placebo (NaCl) i.v. until discharge from ICU (no longer than 13 days) Receives: Drug: Selenase |
| Selenase | Active comparator | Selenase Bolus 4000 microgram i.v. intraoperatively, followed by an daily bolus of Selenase 1000 microgram i.v. until discharge from ICU (no longer than 13 days) Receives: Drug: Selenase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score
Measured: 3 days
Secondary outcomes (4)
length of ICU stay in hours
Measured: outcome at 28 days
incidence of acute renal failure
Measured: 28 days
total requirement of vasoconstrictors
Measured: 28 days
total requirement of fluid replacement therapy
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart; Surgery, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Haberthuer, MD, Principal investigator, Anästhesie/chirurgische Intensivstation Luzerner Kantonsspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141556
- Sponsor's protocol ID
- 236/09
- Status last verified
- Oct 2012
- First submitted
- 8 Jun 2010
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt T, Pargger H, Seeberger E, Eckhart F, von Felten S, Haberthur C. Effect of high-dose sodium selenite in cardiac surgery patients: A randomized controlled bi-center trial. Clin Nutr. 2018 Aug;37(4):1172-1180. doi: 10.1016/j.clnu.2017.04.019. Epub 2017 May 2.
PubMed 28502744
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-dose Intravenous Selenium (Selenase®) on the Systemic Inflammatory Response Syndrome and Related Organ Dysfunction
- ClinicalTrials.gov ID
- NCT01141556
- Acronym / sponsor ID
- 236/09
- Keywords
- selenium, clinical outcome, heart surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Jun 2010 (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.
Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality in critically ill patients. The aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.
Detailed description
Selenium is a essential micronutrient that is present in form of selenocysteine in many enzymes. Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality. Different studies showed that selenium supplementation had beneficial effects in critically ill patients with systemic inflammatory response syndrome (SIRS), reducing the rate of infectious complications and length of hospital stay.
Heart surgery is associated with a complex systemic inflammatory response and the extent correlates with the development of postoperative complications. Former clinical trials used selenium supplementation with a loading dose of normally 1000 to 2000 μg, followed by a daily dosage of 1000 μg. With these dosage regimes pharmacological investigations demonstrated a delayed increase of the selenium concentration in plasma and whole blood. As a result a delayed increase of selenoenzymes can be assumed.
Aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.
Primary endpoints are: Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score and the length of ICU stay in hours.
Secondary endpoints are: incidence of acute renal failure, total requirement of vasoconstrictors and fluid replacement therapy
Inclusion criteria: written informed consent, males and females age ≥ 18 years, patients undergoing an elective heart surgery, normal renal function (serum creatinine ≤ 200 μmol/l)
Exclusion criteria: pregnancy, lack of written concent, emergency operation
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: SelenasePlacebo (NaCl) i.v. intraoperatively, followed by an daily bolus of Placebo (NaCl) i.v. until discharge from ICU (no longer than 13 days) |
| Selenase | Active comparator | Drug: SelenaseSelenase Bolus 4000 microgram i.v. intraoperatively, followed by an daily bolus of Selenase 1000 microgram i.v. until discharge from ICU (no longer than 13 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- written informed consent
- males and females age ≥ 18 years
- patients undergoing an elective heart surgery
- normal renal function (serum creatinine ≤ 200 μmol/l)
Key exclusion criteria (3 listed)
- pregnancy
- lack of written concent
- emergency operation
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 |
|---|---|---|
| SelenaseAlso: Selenase: SeleniumAfter enrollment, patients will be prospectively randomized into two groups: a placebo group without selenium and a group receiving a loading dose of selenium 4000 μg intraoperatively,followed by a daily dosage of 1000 μg until leaving the ICU (longest supplementation 13 days). | Drug | Placebo, Selenase |
Primary outcome
Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score
Time frame: 3 days
4 secondary outcomes
length of ICU stay in hours
Time frame: outcome at 28 days
incidence of acute renal failure
Time frame: 28 days
total requirement of vasoconstrictors
Time frame: 28 days
total requirement of fluid replacement therapy
Time frame: 28 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 25 Oct 2012.
- Derived from this study: PubMed 28502744Schmidt T, Pargger H, Seeberger E, Eckhart F, von Felten S, Haberthur C. Effect of high-dose sodium selenite in cardiac surgery patients: A randomized controlled bi-center trial. Clin Nutr. 2018 Aug;37(4):1172-1180. doi: 10.1016/j.clnu.2017.04.019. Epub 2017 May 2.
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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.
Christoph Haberthuer, MD principal investigator
Anästhesie/chirurgische Intensivstation Luzerner Kantonsspital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selenase in people with Heart; Surgery, Heart, Functional Disturbance as Result and Self Efficacy, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
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 3 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 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score (time frame: 3 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 NCT01141556, which also lists 1 linked publication.
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 25 Oct 2012.