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

NCT02002247 | Unknown Phase 3 DMC

• 1 other identifier: SUSTAIN CSX
• Study Type: interventional
• Target: 1,400
• Locations: 2 countries
• Sites: 23

Brief Summary

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.

Conditions

Heart Disease

Keywords

antioxidants; selenium; heart disease; cardiac surgery; perioperative

Outcome Measures

Primary Outcomes (1)

• 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).

  30 Day

Secondary Outcomes (13)

• 30-Day Mortality

  30 Day

• Hospital Acquired Infections

  30 day

• Perioperative hemodynamic profile

  6 months

• Cardiovascular Complications

  6-months

• Duration of Mechanical Ventilation

  6-months

Other Outcomes (1)

• Laboratory outcomes

  POD 10

Study Arms (2)

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.

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.

Drug: sodium selenite

Interventions

sodium selenite DRUG

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.

Also known as: selenium

sodium selenite

Placebo DRUG

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.

Also known as: NaCl 0.9%

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Daren K. Heyland: lead
• biosyn Arzneimittel GmbH: collaborator
• Queen's University: collaborator
• RWTH Aachen University: collaborator

Study Sites (23)

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Institut de cardiologie de Montreal

Montreal, Quebec, H1C1T8, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Sacre Coeur

Montreal, Quebec, Canada

Location

IUCPQ

Québec, Quebec, Canada

Location

Centre de recherche CIUSSS de l'Estrie CHUS

Sherbrooke, Quebec, Canada

Location

RWTH Aachen University Hospital

Aachen, 52074, Germany

Location

Klinik und Poliklinik für Anästhesiologie und Operative Intensivmedizin Universitätsklinikum Bonn

Bonn, Germany

Location

Klinik und Poliklinik für Herz- und Thoraxchirurgie Uniklinik Köln

Cologne, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Klinik für Her- und Gefäßchirurgie Universitäts-Herzzentrum Freiburg

Freiburg im Breisgau, Germany

Location

Klinik für Herz-, Kinderherz- und Gefäßchirurgie UKGM Giessen

Giessen, Germany

Location

University Medical Center Schleswig-Holstein

Kiel, Germany

Location

Klinik für Anästhesiologie Universitätsmedizin Mainz

Mainz, Germany

Location

Klinik für Anästhesiologie Klinikum der Universität München

München, Germany

Location

Klinik für Anästhesiologie, operative Intensivmedizin und Schmerztherapie Universitätsmedizin Münster, Zentralklinikum

Münster, Germany

Location

Klinikum Oldenburg gGmbH Universitätsklinik für Anästhesiologie / Intensivmedizin / Notfallmedizin / Schmerztherapie

Oldenburg, Germany

Location

Related Publications (2)

• 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.

  PMID: 36630120 DERIVED

• 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.

  PMID: 25169040 DERIVED

MeSH Terms

Conditions

Heart Diseases

Interventions

Sodium Selenite; Selenium; Sodium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Selenious Acid; Selenium Compounds; Inorganic Chemicals; Sodium Compounds; Chalcogens; Elements; Minerals; Chlorides; Hydrochloric Acid; Chlorine Compounds

Study Officials

• Daren K Heyland, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

• Christian Stoppe, MD

  RWTH Aachen University Hospital

  PRINCIPAL INVESTIGATOR

• Bernard J McDonald, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: November 28, 2013
• First Posted: December 5, 2013
• Study Start: January 1, 2015
• Primary Completion: February 1, 2021
• Study Completion: July 1, 2021
• Last Updated: June 1, 2021

Record last verified: 2021-05

Locations

CA (12); DE (11)