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Completed

NCT Number: NCT02530788

High-dose Selenium Supplementation in Patients With Left Ventricular Assist

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.

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Key information

Conditions

Ventricular Dysfunction, Left Cardiovascular Diseases Heart Diseases Heart Failure Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selenium Supplement (sodium selenite)

Drug

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

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Collaborators

  • Cardiodevice Stiftung
  • biosyn Arzneimittel GmbH

Registry information

Official study title

Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial

Acronym: SOS-LVAD

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Aug 21, 2015
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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