Heart DiseasePhase 3SUSTAINCSXNCT02002247

SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX®-Trial).

A Phase 3 study testing sodium selenite in people with Heart Disease, run by Daren K. Heyland at 23 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Disease
What is being tested?: sodium selenite
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,400 participants
Where: 23 sitesin 2 countries
Study dates: Jan 2015to Jul 2021
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

Adult patients (>/=18 years of age)
Scheduled to undergo elective or urgent cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest that exhibit a high perioperative risk profile as defined by the presence of one or more of the following:
a) Planned valve surgery combined with CABG or multiple valve replacement/repair surgeries or combined cardiac surgical procedures involving the thoracic aorta; OR
b) Any cardiac surgery with a high perioperative risk profile, defined as a predicted operative mortality of ≥ 5% (EuroSCORE II).

Who cannot join

We will exclude patients who meet any of the following criteria:
Isolated procedures (CABG only or valve)
Known hypersensitivity to sodium-selenite or to any of the constituents of the solution.
Renal failure requiring dialysis at the point of screening.
Chronic liver disease as evidenced by a pre-operative total bilirubin >2 mg/dl or 34 umol/L.
Disabling neuropsychiatric disorders (severe dementia, severe Alzheimer's disease, advanced Parkinson's disease).

Show all 10Show fewer

Pregnancy or lactation period.
Simultaneous participation in another clinical trial of an experimental therapy (co-enrolment acceptable in observational studies or randomized trials of existing therapies if permitted by both steering committees and local ethics boards).
Patients undergoing heart transplantation or preoperative planned LVAD insertion or complex congenital heart surgery.
Alternate contacts of investigators (required by German Regulatory Authorities).

Trial locations and contacts

23 sites in 2 countries.

Country

City, postcode or hospital

23 sites in 2 countries

Canada12 sites

Hamilton General Hospital
Hamilton, Ontario
London Health Sciences Centre
London, Ontario
Institut de cardiologie de Montreal
Montreal, Quebec, H1C1T8
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
McGill University Health Centre
Montreal, Quebec
Sacre Coeur
Montreal, Quebec
University of Ottawa Heart Institute
Ottawa, Ontario
IUCPQ
Québec, Quebec
Centre de recherche CIUSSS de l'Estrie CHUS
Sherbrooke, Quebec
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
St. Michael's Hospital
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario

Other trials in Canada

Germany11 sites

RWTH Aachen University Hospital
Aachen, 52074
Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin Universitätsklinikum Bonn
Bonn
Klinik und Poliklinik für Herz- und Thoraxchirurgie Uniklinik Köln
Cologne
Universitätsklinikum Frankfurt
Frankfurt, 60590
Klinik für Her- und Gefäßchirurgie Universitäts-Herzzentrum Freiburg
Freiburg im Breisgau
Klinik für Herz-, Kinderherz- und Gefäßchirurgie UKGM Giessen
Giessen
University Medical Center Schleswig-Holstein
Kiel
Klinik für Anästhesiologie Universitätsmedizin Mainz
Mainz
Klinik für Anästhesiologie Klinikum der Universität München
München
Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie Universitätsmedizin Münster, Zentralklinikum
Münster
Klinikum Oldenburg gGmbH Universitätsklinik für Anästhesiologie / Intensivmedizin / Notfallmedizin / Schmerztherapie
Oldenburg

Other trials in Germany

About this study

Official title: SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX®-Trial). A Multicentre Randomized Controlled Trial of High Dose Sodium-selenite Administration in High Risk Cardiac Surgical Patients

The aim of the investigators' research program is to investigate the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a fewer complications, less organ injury and fewer deaths. Before the investigators conducted the large definitive trial, they conducted a pilot study to assess the feasibility of the protocol, and are rolling the pilot patients into the definitive trial.

Read the detailed description

Over a million patients undergo open heart surgery annually and this number is likely to accelerate as the population ages and the prevalence of diabetes and cardiovascular disease continue to increase. Unfortunately, death, organ failure, and other serious complications are all too frequent following open heart surgery, especially in some high-risk patient populations.

Selenium is a trace element that is important for many of the body's regulatory and metabolic functions especially during times of stress. International members of the study team have shown in a non-randomized study that high dose selenium supplementation was associated with improved clinical outcomes compared to a historical control group. The next step in this program of research is to conduct a randomized trial.

The aim of this research program is to investigate the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to fewer complications, less organ injury and fewer deaths.

The investigators propose to conduct a randomized, placebo-controlled, double-blind, multicentre definitive trial of 1400 patients across 20 sites in Germany and Canada, which will include the pilot study patients. An industry partner (Biosyn) will provide the product and some additional support for the European sites. Patients will be randomized to receive either a daily perioperative high-dose selenium or placebo until postoperative day 10 (maximum) or upon earlier discharge from ICU. If the hypothesis is proven true, and this simple, inexpensive nutrient reduces complications and improves recovery of patients undergoing cardiac surgery, there is the potential to dramatically change clinical practice and improve health outcomes.

Conditions: Heart Disease
Being tested: sodium selenite, Placebo
Keywords: antioxidants, selenium, heart disease, cardiac surgery, perioperative
Medical subject headings: Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

sodium seleniteDrug
Also called selenium
All subjects will receive an IV bolus of 2000µg selenium within 30min after induction of anesthesia via the central venous catheter. After termination of surgery, immediately after admission to the ICU, all patients will receive a second bolus of 2000µg selenium. Then on every further morning during ICU-stay, patients will receive an IV bolus of 1000µg selenium via central or peripheral venous access until death, discharge from ICU to the ward, or for a maximum of 10 days.
PlaceboDrug
Also called NaCl 0.9%
All patients will receive an IV bolus of normal saline (equals to 40ml prepared solution) within 30min after induction of anesthesia via the central venous catheter. After termination of surgery, immediately after admission to the ICU, all patients will receive a second bolus of normal saline accordingly. Then on every further morning during ICU-stay, patients will receive an IV bolus of normal saline via central or peripheral venous access until death, discharge from ICU to the ward (treatment may continue in a step down or intermediate care unit), or for a maximum of 10 days.

Study groups in NCT02002247
Study group	Role	What they receive
Placebo	Placebo comparator	Normal saline will be administered to subjects intravenously pre-operatively, upon admission to the ICU, then daily up to post-operative day 10 or ICU discharge, whichever occurs first. Receives: Drug: Placebo
sodium selenite	Active comparator	High-dose sodium-selenite will be administered to subjects intravenously: 1) pre-operatively (2000 ug); 2) upon admission to the ICU (2000 ug), 3) then daily (1000 ug) up to post-operative day 10 or ICU discharge, whichever occurs first. Receives: Drug: sodium selenite

What is being measured

The primary outcome is the main question the study is designed to answer.

PODS free days + alive
Evaluate the PODS free days + alive as the primary outcome for the large-scale Phase III trial. We define PODS as the need for life-sustaining therapies (mechanical ventilation, vasopressor therapy, mechanical circulatory support, continuous renal replacement therapy, or intermittent hemodialysis).
Measured: 30 Day

Secondary outcomes (13)

30-Day Mortality
Mortality 30 days post-randomization.
Measured: 30 Day
Hospital Acquired Infections
To be evaluated up to 6 months post-randomization.
Measured: 30 day
Perioperative hemodynamic profile
This includes: mean arterial blood pressure, cardiac power index, systemic vascular resistance, etc... To be assessed up to 6-months post-randomization.
Measured: 6 months
Cardiovascular Complications
This includes: arrhythmias, cardiac arrest, infarction. To be assessed up to 6-months.
Measured: 6-months
Duration of Mechanical Ventilation
To be assessed up to 6-months.
Measured: 6-months
Incidence of post-operative delirium
Assessed by CAM-ICU score. To be assessed up to 6-months.
Measured: 6-months
ICU Length of stay
To be assessed up to 6 months post-randomization.
Measured: 6-months
Hospital Re-admission Rates
To be assessed up to 6-months post-randomization.
Measured: 6-months
Hospital Length of stay
To be assessed up to 6 months post-randomization.
Measured: 6-months
6-Month Survival
To be assessed at 6 months post-randomization.
Measured: 6-months
Quality of Life
Health related quality of life to be assessed up to 6-months post-randomization.
Measured: 6-months
Return to work
Assessed using a questionnaire to determine the patient's ability to return to their pre-operative working capabilities. To be assessed up to 6 months post-randomization.
Measured: 6-months
6-minute walking test
6-minute walking distance
Measured: up to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jul 2021

First posted5 Dec 2013 (estimated)
Study startJan 2015
Primary completionFeb 2021
Study completionJul 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Heart DiseaseStudies 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: 1,400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02002247
Sponsor's protocol ID: SUSTAIN CSX
Acronym: SUSTAINCSX
Status last verified: May 2021
First submitted: 28 Nov 2013
Last updated: 1 Jun 2021
Results posted: No
Data monitoring committee: Yes

Publications

Zayat R, Kolashov A, Stoppe C, Notz Q, Shieba Y, Moza A, Catena D, Mohsen G, Beer J, Duerr GD, Mohammed AFA. Sex Differences in Postoperative Recovery and Mortality After High-Risk Cardiac Surgery: A Propensity Score-Matched Post Hoc Analysis of the SUSTAIN-CSX Trial. J Am Heart Assoc. 2026 Aug 20:e049243. doi: 10.1161/JAHA.126.049243. Online ahead of print.
PubMed 42622119
Dresen E, Heyland DK, Lee ZY, O'Brien B, Elke G, Radke DI, Meybohm P, Schoenrath F, Sundermann SH, von Dossow V, McDonald B, Christopher KB, Fremes SE, Mohammadi S, Niemann B, Boning A, Mazer CD, Ke L, Zarbock A, Day AG, Stoppe C. Pre- and Immediate Postoperative Prediction Model for Organ Dysfunction or Death Early After Cardiac Surgery: A Post Hoc Analysis of a Multicenter Randomized Trial. J Am Heart Assoc. 2026 Jul 21;15(14):e044394. doi: 10.1161/JAHA.125.044394. Epub 2026 Jul 17.
PubMed 42466520
Stoppe C, McDonald B, Meybohm P, Christopher KB, Fremes S, Whitlock R, Mohammadi S, Kalavrouziotis D, Elke G, Rossaint R, Helmer P, Zacharowski K, Gunther U, Parotto M, Niemann B, Boning A, Mazer CD, Jones PM, Ferner M, Lamarche Y, Lamontagne F, Liakopoulos OJ, Cameron M, Muller M, Zarbock A, Wittmann M, Goetzenich A, Kilger E, Schomburg L, Day AG, Heyland DK; SUSTAIN CSX Study Collaborators. Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients: The SUSTAIN CSX Randomized Clinical Trial. JAMA Surg. 2023 Mar 1;158(3):235-244. doi: 10.1001/jamasurg.2022.6855.
PubMed 36630120
Stoppe C, McDonald B, Rex S, Manzanares W, Whitlock R, Fremes S, Fowler R, Lamarche Y, Meybohm P, Haberthur C, Rossaint R, Goetzenich A, Elke G, Day A, Heyland DK. SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients. Trials. 2014 Aug 28;15:339. doi: 10.1186/1745-6215-15-339.
PubMed 25169040

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX®-Trial). A Multicentre Randomized Controlled Trial of High Dose Sodium-selenite Administration in High Risk Cardiac Surgical Patients
ClinicalTrials.gov ID: NCT02002247
Acronym / sponsor ID: SUSTAINCSX / SUSTAIN CSX
Conditions: Heart Disease
Keywords: antioxidants, selenium, heart disease, cardiac surgery, perioperative
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,400 participants (estimated)
Lead sponsor: Daren K. HeylandUniversity, hospital or other
Collaborators: biosyn Arzneimittel GmbH, Queen's University, RWTH Aachen University
Study start: Jan 2015
Primary completion: Feb 2021 (actual)
Study completion: Jul 2021 (estimated)
First posted: 5 Dec 2013 (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.

Detailed description

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: PlaceboNormal saline will be administered to subjects intravenously pre-operatively, upon admission to the ICU, then daily up to post-operative day 10 or ICU discharge, whichever occurs first.
sodium selenite	Active comparator	Drug: sodium seleniteHigh-dose sodium-selenite will be administered to subjects intravenously: 1) pre-operatively (2000 ug); 2) upon admission to the ICU (2000 ug), 3) then daily (1000 ug) up to post-operative day 10 or ICU discharge, whichever occurs first.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult patients (>/=18 years of age)
Scheduled to undergo elective or urgent cardiac surgery with the use of cardiopulmonary bypass (CPB) and cardioplegic arrest that exhibit a high perioperative risk profile as defined by the presence of one or more of the following:

Key exclusion criteria (10 listed)

Isolated procedures (CABG only or valve)
Known hypersensitivity to sodium-selenite or to any of the constituents of the solution.
Renal failure requiring dialysis at the point of screening.
Chronic liver disease as evidenced by a pre-operative total bilirubin >2 mg/dl or 34 umol/L.
Disabling neuropsychiatric disorders (severe dementia, severe Alzheimer's disease, advanced Parkinson's disease).

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
sodium seleniteAlso: seleniumAll subjects will receive an IV bolus of 2000µg selenium within 30min after induction of anesthesia via the central venous catheter. After termination of surgery, immediately after admission to the ICU, all patients will receive a second bolus of 2000µg selenium. Then on every further morning during ICU-stay, patients will receive an IV bolus of 1000µg selenium via central or peripheral venous access until death, discharge from ICU to the ward, or for a maximum of 10 days.	Drug	sodium selenite
PlaceboAlso: NaCl 0.9%All patients will receive an IV bolus of normal saline (equals to 40ml prepared solution) within 30min after induction of anesthesia via the central venous catheter. After termination of surgery, immediately after admission to the ICU, all patients will receive a second bolus of normal saline accordingly. Then on every further morning during ICU-stay, patients will receive an IV bolus of normal saline via central or peripheral venous access until death, discharge from ICU to the ward (treatment may continue in a step down or intermediate care unit), or for a maximum of 10 days.	Drug	Placebo

Primary outcome

PODS free days + alive
Time frame: 30 Day
Evaluate the PODS free days + alive as the primary outcome for the large-scale Phase III trial. We define PODS as the need for life-sustaining therapies (mechanical ventilation, vasopressor therapy, mechanical circulatory support, continuous renal replacement therapy, or intermittent hemodialysis).

13 secondary outcomes

30-Day Mortality
Time frame: 30 Day
Hospital Acquired Infections
Time frame: 30 day
Perioperative hemodynamic profile
Time frame: 6 months
Cardiovascular Complications
Time frame: 6-months
Duration of Mechanical Ventilation
Time frame: 6-months
Incidence of post-operative delirium
Time frame: 6-months
ICU Length of stay
Time frame: 6-months
Hospital Re-admission Rates
Time frame: 6-months
Hospital Length of stay
Time frame: 6-months
6-Month Survival
Time frame: 6-months
Quality of Life
Time frame: 6-months
Return to work
Time frame: 6-months
6-minute walking test
Time frame: up to 3 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2021.
Derived from this study: PubMed 42622119Zayat R, Kolashov A, Stoppe C, Notz Q, Shieba Y, Moza A, Catena D, Mohsen G, Beer J, Duerr GD, Mohammed AFA. Sex Differences in Postoperative Recovery and Mortality After High-Risk Cardiac Surgery: A Propensity Score-Matched Post Hoc Analysis of the SUSTAIN-CSX Trial. J Am Heart Assoc. 2026 Aug 20:e049243. doi: 10.1161/JAHA.126.049243. Online ahead of print.
Derived from this study: PubMed 42466520Dresen E, Heyland DK, Lee ZY, O'Brien B, Elke G, Radke DI, Meybohm P, Schoenrath F, Sundermann SH, von Dossow V, McDonald B, Christopher KB, Fremes SE, Mohammadi S, Niemann B, Boning A, Mazer CD, Ke L, Zarbock A, Day AG, Stoppe C. Pre- and Immediate Postoperative Prediction Model for Organ Dysfunction or Death Early After Cardiac Surgery: A Post Hoc Analysis of a Multicenter Randomized Trial. J Am Heart Assoc. 2026 Jul 21;15(14):e044394. doi: 10.1161/JAHA.125.044394. Epub 2026 Jul 17.
Derived from this study: PubMed 36630120Stoppe C, McDonald B, Meybohm P, Christopher KB, Fremes S, Whitlock R, Mohammadi S, Kalavrouziotis D, Elke G, Rossaint R, Helmer P, Zacharowski K, Gunther U, Parotto M, Niemann B, Boning A, Mazer CD, Jones PM, Ferner M, Lamarche Y, Lamontagne F, Liakopoulos OJ, Cameron M, Muller M, Zarbock A, Wittmann M, Goetzenich A, Kilger E, Schomburg L, Day AG, Heyland DK; SUSTAIN CSX Study Collaborators. Effect of High-Dose Selenium on Postoperative Organ Dysfunction and Mortality in Cardiac Surgery Patients: The SUSTAIN CSX Randomized Clinical Trial. JAMA Surg. 2023 Mar 1;158(3):235-244. doi: 10.1001/jamasurg.2022.6855.
Derived from this study: PubMed 25169040Stoppe C, McDonald B, Rex S, Manzanares W, Whitlock R, Fremes S, Fowler R, Lamarche Y, Meybohm P, Haberthur C, Rossaint R, Goetzenich A, Elke G, Day A, Heyland DK. SodiUm SeleniTe Adminstration IN Cardiac Surgery (SUSTAIN CSX-trial): study design of an international multicenter randomized double-blinded controlled trial of high dose sodium-selenite administration in high-risk cardiac surgical patients. Trials. 2014 Aug 28;15:339. doi: 10.1186/1745-6215-15-339.

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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.

Daren K Heyland, MD principal investigator

Queen's University

Christian Stoppe, MD principal investigator

RWTH Aachen University Hospital

Bernard J McDonald, MD principal investigator

Ottawa Heart Institute Research Corporation

23 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing sodium selenite in people with Heart Disease, run by Daren K. Heyland at 23 sites in 2 countries.

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 10 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: status not confirmed, as of the sponsor's last update on 1 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Canada, 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?

Results are not available in the source record.

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?

PODS free days + alive (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 NCT02002247, which also lists 4 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 1 Jun 2021.