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High-dose Selenium Supplementation in Patients With Left Ventricular Assist (SOS-LVAD)

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ClinicalTrials.gov Identifier: NCT02530788
Recruitment Status : Completed
First Posted : August 21, 2015
Last Update Posted : February 7, 2018
Sponsor:
Collaborators:
biosyn Arzneimittel GmbH
Cardiodevice Stiftung
Information provided by (Responsible Party):
RWTH Aachen University

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Ventricular Dysfunction, Left Drug: Selenium Supplement (sodium selenite) Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial
Actual Study Start Date : August 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Selenium Supplement (sodium selenite)
Active arm receiving Selenium in form of sodium selenite
Drug: Selenium Supplement (sodium selenite)

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).

Other Names:
  • Selenase (R) 300 RP
  • Selenase (R) T

Placebo Comparator: Placebo
Placebo arm receiving Sodium Chloride solution
Drug: Placebo

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).





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Mortality [ Time Frame: postoperative day 28 ]
    via telephone enquiry

  2. Persistent organ dysfunction [ Time Frame: postoperative day 7 ]
    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

  3. 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 ]
  4. Acute renal failure [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days ]
    (quantified with RIFLE score)

  5. Mechanical Ventilation [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days ]
    Time of mechanical ventilation (measured in hours after successful intubation) and necessity of re-intubation

  6. postoperative delirium [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days ]
    Evaluation of delirium by confusion assessment method: CAM-ICU score

  7. 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. ]
  8. Quality of Life [ Time Frame: postoperative day 28 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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

Exclusion criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530788


Locations
Germany
Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
biosyn Arzneimittel GmbH
Cardiodevice Stiftung
Investigators
Principal Investigator: Andreas Goetzenich, MD, PhD Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
Principal Investigator: Christian Stoppe, MD Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02530788     History of Changes
Other Study ID Numbers: 13-036
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Keywords provided by RWTH Aachen University:
Heart Failure
Cardiac Surgery
Ventricular Assist Device
Selenium

Additional relevant MeSH terms:
Ventricular Dysfunction
Ventricular Dysfunction, Left
Heart Diseases
Cardiovascular Diseases
Selenium
Selenious Acid
Sodium Selenite
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances