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

Primary Purpose

Ventricular Dysfunction, Left

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Selenium Supplement (sodium selenite)
Placebo
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Dysfunction, Left focused on measuring Heart Failure, Cardiac Surgery, Ventricular Assist Device, Selenium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Selenium Supplement (sodium selenite)

Placebo

Arm Description

Active arm receiving Selenium in form of sodium selenite

Placebo arm receiving Sodium Chloride solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality
via telephone enquiry
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
Incidence of nosocomial infections acquired at ICU
Acute renal failure
(quantified with RIFLE score)
Mechanical Ventilation
Time of mechanical ventilation (measured in hours after successful intubation) and necessity of re-intubation
postoperative delirium
Evaluation of delirium by confusion assessment method: CAM-ICU score
Selenium concentration in whole blood, activity of glutathion-peroxidase, concentration of Selenoprotein-P (Sel-P)
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.

Full Information

First Posted
August 17, 2015
Last Updated
February 6, 2018
Sponsor
RWTH Aachen University
Collaborators
biosyn Arzneimittel GmbH, Cardiodevice Stiftung
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1. Study Identification

Unique Protocol Identification Number
NCT02530788
Brief Title
High-dose Selenium Supplementation in Patients With Left Ventricular Assist
Acronym
SOS-LVAD
Official Title
Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University
Collaborators
biosyn Arzneimittel GmbH, Cardiodevice Stiftung

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Dysfunction, Left
Keywords
Heart Failure, Cardiac Surgery, Ventricular Assist Device, Selenium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selenium Supplement (sodium selenite)
Arm Type
Active Comparator
Arm Description
Active arm receiving Selenium in form of sodium selenite
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm receiving Sodium Chloride solution
Intervention Type
Drug
Intervention Name(s)
Selenium Supplement (sodium selenite)
Other Intervention Name(s)
Selenase (R) 300 RP, Selenase (R) T
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
Composite Outcome: independence from specific ICU procedures
Description
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
Time Frame
postoperative day 28
Secondary Outcome Measure Information:
Title
Mortality
Description
via telephone enquiry
Time Frame
postoperative day 28
Title
Persistent organ dysfunction
Description
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
Time Frame
postoperative day 7
Title
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
Title
Acute renal failure
Description
(quantified with RIFLE score)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Title
Mechanical Ventilation
Description
Time of mechanical ventilation (measured in hours after successful intubation) and necessity of re-intubation
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Title
postoperative delirium
Description
Evaluation of delirium by confusion assessment method: CAM-ICU score
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Title
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.
Title
Quality of Life
Description
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.
Time Frame
postoperative day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Goetzenich, MD, PhD
Organizational Affiliation
Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Stoppe, MD
Organizational Affiliation
Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
City
Aachen
State/Province
NRW
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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High-dose Selenium Supplementation in Patients With Left Ventricular Assist

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