Ventricular Dysfunction, LeftPhase 3SOS-LVADNCT02530788
High-dose Selenium Supplementation in Patients With Left Ventricular Assist
A Phase 3 study testing Selenium Supplement (sodium selenite) in people with Ventricular Dysfunction, Left, run by RWTH Aachen University at 1 site in Germany.
Trial summary
This planned pilot study is a monocentric, prospective, double-blind randomized and placebo controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Dysfunction, Left
- What is being tested?
- Selenium Supplement (sodium selenite)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Jan 2018
- 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
- Patients with chronic left ventricular heart failure, who undergo LVAD Implant surgery (including other heart surgery)
- Full aged, contractually capable, male and female patients
- Patients that are capable and willing to understand and obey the instructions of the study staff.
- Signed informed consent
Who cannot join
- Selenium intoxication
- Patients with contraindications to the planned intervention, due to diseases
- Severe exacerbation of comorbidities such as renal failure requiring dialysis or liver dysfunction (defined as bilirubin >2mg/dl)
- Known hypersensitivity to the trial medication (selenase® 300 RP, selenase® T), to any of the constituents of the solution or to the placebo
- Patients that are not contractually capable; Patients accommodated to a facility by court order or public authority
- Pregnancy or lactation period
Show all 11Show fewer
- Women at reproductive age, without suitable contraception
- Patients in a relationship of dependency or in employment with the head of study's
- Underaged
- No signed informed consent
- Simultaneous participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial
This planned pilot study is a monocentric, prospective, double-blind randomized and placebo controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.
The aim of the present trial is to provide the scientific rationale for a large multicenter clinical trial, investigating the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery with prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a faster independency from life-sustaining technologies in the ICU and a decrease of postoperative morbidity and mortality. Before proceeding to the large-scale, definitive trial, the investigators propose to conduct a pilot study of the definitive randomized trial, to determine the feasibility of the study protocol.
- Conditions
- Ventricular Dysfunction, Left
- Being tested
- Selenium Supplement (sodium selenite), Placebo
- Keywords
- Heart Failure, Cardiac Surgery, Ventricular Assist Device, Selenium
- Medical subject headings
- Ventricular Dysfunction, Left, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium Supplement (sodium selenite)Drug
Also called Selenase (R) 300 RP, Selenase (R) T
On the evening before operation the patient receives the first dosage of Selenium (300µg orally) orally as a pill.
After induction of anaesthesia and before being put on the heart-lung-machine the patient receives 3000µg Selenium as sodium selenite (selenase® T) intravenous (as bolus infusion in the space of 30 minutes). In addition the patient gets 1000µg Selenium as sodium selenite (selenase® T) intravenous as bolus infusion in the space of 30 minutes after admission to ICU. On every POD the patient receives 1000µg Selenium as sodium selenite (selenase® T) intravenous as bolus infusion in the space of 30 minutes (until transfer to standard care unit or maximum substitution until 13th POD).
PlaceboDrug
On the evening before operation the patient receives the first dosage of placebo orally as a pill.
After induction of anaesthesia and before being put on the heart-lung-machine the patient receives placebo intravenous (as bolus infusion in the space of 30 minutes). In addition the patient gets placebo intravenous as bolus infusion in the space of 30 minutes after admission to ICU. On every POD the patient receives placebo intravenous as bolus infusion in the space of 30 minutes (until transfer to standard care unit or maximum substitution until 13th POD).
| Study group | Role | What they receive |
|---|---|---|
| Selenium Supplement (sodium selenite) | Active comparator | Active arm receiving Selenium in form of sodium selenite Receives: Drug: Selenium Supplement (sodium selenite) |
| Placebo | Placebo comparator | Placebo arm receiving Sodium Chloride solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Outcome: independence from specific ICU procedures
As primary outcome, the investigators have chosen a composite outcome. This allows to assess the postoperative process of the included patients irrespective of extrinsic sources of irritation (e.g. daily routine, clinic based processes). The independency from specific ICU procedures is taken as a primary target (time is taken from postoperative admission to ICU after implantation of LVAD until the end of the characteristic ICU procedures):
- mechanical ventilation
- vasopressor therapy
- mechanical circulatory support
- renal replacement therapy
Measured: postoperative day 28
Secondary outcomes (8)
Mortality
via telephone enquiry
Measured: postoperative day 28
Persistent organ dysfunction
Persistent organ dysfunction quantified upon day 7 (or upon day of discharge from hospital) with "Sequential Organ Failure Assessment Score" (SOFA), "Multiple Organ Dysfunction Score" (MODS) and "Simplified Acute Physiology Score" (SAPS), daily quantification while ICU stay
Measured: postoperative day 7
Incidence of nosocomial infections acquired at ICU
Measured: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Acute renal failure
(quantified with RIFLE score)
Measured: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Mechanical Ventilation
Time of mechanical ventilation (measured in hours after successful intubation) and necessity of re-intubation
Measured: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
postoperative delirium
Evaluation of delirium by confusion assessment method: CAM-ICU score
Measured: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Selenium concentration in whole blood, activity of glutathion-peroxidase, concentration of Selenoprotein-P (Sel-P)
Measured: preoperative, by the end of surgery, on day 1, 3, 5, 7, 13, and if the patient is still in hospital, on day 28.
Quality of Life
The patients individual "Quality of Life" (pre- and postoperative) quantified with "MACNEW - Health related quality of life in heart disease - Scale" quantified postoperative upon discharge from hospital and on the 28th POD via telephone inquiry. If the patient cannot be contacted via telephone on the 28th POD, we will try to reach the patient on the following 7 days.
Measured: postoperative day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJul 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Dysfunction, LeftStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Collaborators
- biosyn Arzneimittel GmbH, Cardiodevice Stiftung
- Responsible party
- Sponsor
- Investigators
- Andreas Goetzenich, MD, PhD, Principal investigator, Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH AachenChristian Stoppe, MD, Principal investigator, Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530788
- Sponsor's protocol ID
- 13-036
- Acronym
- SOS-LVAD
- Status last verified
- Feb 2018
- First submitted
- 17 Aug 2015
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02530788
- Acronym / sponsor ID
- SOS-LVAD / 13-036
- Conditions
- Ventricular Dysfunction, Left
- Keywords
- Heart Failure, Cardiac Surgery, Ventricular Assist Device, Selenium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Collaborators
- biosyn Arzneimittel GmbH, Cardiodevice Stiftung
- Study start
- Aug 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 21 Aug 2015 (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 planned pilot study is a monocentric, prospective, double-blind randomized and placebo controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III.
The aim of the present trial is to provide the scientific rationale for a large multicenter clinical trial, investigating the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery with prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a faster independency from life-sustaining technologies in the ICU and a decrease of postoperative morbidity and mortality. Before proceeding to the large-scale, definitive trial, the investigators propose to conduct a pilot study of the definitive randomized trial, to determine the feasibility of the study protocol.
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 Supplement (sodium selenite) | Active comparator | Drug: Selenium Supplement (sodium selenite)Active arm receiving Selenium in form of sodium selenite |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo arm receiving Sodium Chloride solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chronic left ventricular heart failure, who undergo LVAD Implant surgery (including other heart surgery)
- Full aged, contractually capable, male and female patients
- Patients that are capable and willing to understand and obey the instructions of the study staff.
- Signed informed consent
Key exclusion criteria (11 listed)
- Selenium intoxication
- Patients with contraindications to the planned intervention, due to diseases
- Severe exacerbation of comorbidities such as renal failure requiring dialysis or liver dysfunction (defined as bilirubin >2mg/dl)
- Known hypersensitivity to the trial medication (selenase® 300 RP, selenase® T), to any of the constituents of the solution or to the placebo
- Patients that are not contractually capable; Patients accommodated to a facility by court order or public authority
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 Supplement (sodium selenite)Also: Selenase (R) 300 RP, Selenase (R) TOn the evening before operation the patient receives the first dosage of Selenium (300µg orally) orally as a pill. After induction of anaesthesia and before being put on the heart-lung-machine the patient receives 3000µg Selenium as sodium selenite (selenase® T) intravenous (as bolus infusion in the space of 30 minutes). In addition the patient gets 1000µg Selenium as sodium selenite (selenase® T) intravenous as bolus infusion in the space of 30 minutes after admission to ICU. On every POD the patient receives 1000µg Selenium as sodium selenite (selenase® T) intravenous as bolus infusion in the space of 30 minutes (until transfer to standard care unit or maximum substitution until 13th POD). | Drug | Selenium Supplement (sodium selenite) |
| PlaceboOn the evening before operation the patient receives the first dosage of placebo orally as a pill. After induction of anaesthesia and before being put on the heart-lung-machine the patient receives placebo intravenous (as bolus infusion in the space of 30 minutes). In addition the patient gets placebo intravenous as bolus infusion in the space of 30 minutes after admission to ICU. On every POD the patient receives placebo intravenous as bolus infusion in the space of 30 minutes (until transfer to standard care unit or maximum substitution until 13th POD). | Drug | Placebo |
Primary outcome
Composite Outcome: independence from specific ICU procedures
Time frame: postoperative day 28
As primary outcome, the investigators have chosen a composite outcome. This allows to assess the postoperative process of the included patients irrespective of extrinsic sources of irritation (e.g. daily routine, clinic based processes). The independency from specific ICU procedures is taken as a primary target (time is taken from postoperative admission to ICU after implantation of LVAD until the end of the characteristic ICU procedures): * mechanical ventilation * vasopressor therapy * mechanical circulatory support * renal replacement therapy
8 secondary outcomes
Mortality
Time frame: postoperative day 28
Persistent organ dysfunction
Time frame: postoperative day 7
Incidence of nosocomial infections acquired at ICU
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Acute renal failure
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Mechanical Ventilation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
postoperative delirium
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Selenium concentration in whole blood, activity of glutathion-peroxidase, concentration of Selenoprotein-P (Sel-P)
Time frame: preoperative, by the end of surgery, on day 1, 3, 5, 7, 13, and if the patient is still in hospital, on day 28.
Quality of Life
Time frame: postoperative day 28
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 7 Feb 2018.
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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.
Andreas Goetzenich, MD, PhD principal investigator
Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
Christian Stoppe, MD principal investigator
Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selenium Supplement (sodium selenite) in people with Ventricular Dysfunction, Left, run by RWTH Aachen University at 1 site in Germany.
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 11 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 7 Feb 2018. 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 Germany. 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?
Composite Outcome: independence from specific ICU procedures (time frame: postoperative day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2018.