Clinical trial NCT02530788: High-dose Selenium Supplementation in Patients With Left Ventricular Assist
Official title: Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ventricular Dysfunction, Left
Keywords: Heart Failure
Cardiac Surgery
Ventricular Assist Device
Selenium
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: biosyn Arzneimittel GmbH
name: Cardiodevice Stiftung
First posted: 2015-08-21
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Composite Outcome: independence from specific ICU procedures
timeFrame: postoperative day 28
Secondary outcomes:
measure: Mortality
timeFrame: postoperative day 28
measure: Persistent organ dysfunction
timeFrame: postoperative day 7
measure: Incidence of nosocomial infections acquired at ICU
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
measure: Acute renal failure
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
measure: Mechanical Ventilation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
measure: postoperative delirium
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
measure: Selenium concentration in whole blood, activity of glutathion-peroxidase, concentration of Selenoprotein-P (Sel-P)
timeFrame: preoperative, by the end of surgery, on day 1, 3, 5, 7, 13, and if the patient is still in hospital, on day 28.
measure: Quality of Life
timeFrame: postoperative day 28
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
state: NRW
Study officials:
affiliation: Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
name: Andreas Goetzenich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen
name: Christian Stoppe, MD
role: PRINCIPAL_INVESTIGATOR
References: