HIGH DOSE SUPPLEMENTATION OF SELENIUM IN LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT SURGERY – A DOUBLE BLIND RANDOMISED CONTROLLED TRIAL

HIGH DOSE SUPPLEMENTATION OF SELENIUM IN LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT SURGERY – A DOUBLE BLIND RANDOMISED CONTROLLED TRIAL - SOS-LVAD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001357-26-DE

Enrollment

Registered

2014-04-01

Start date

2014-08-04

Completion date

Unknown

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selenium is a key component of a number of selenoproteins which protect against oxidative stress and is well recognised for its prominent role in immune defence. Selenoproteins have the potential to reduce inflammatory reactions e.g. after trauma, sepsis or multi organ failure. However, Germany is a shortage region for Selenium. Especially patients in need of treatment requiring the use of heart-lung-machines have shown a significant decrease of Selenium levels after surgery. MedDRA version: 17

Interventions

Trade Name: selenase T pro injectione (20ml) Pharmaceutical Form: Solution for injection CAS Number: 7782-49-2 Current Sponsor code: 13-036 Other descriptive name: SELENIUM Concentration unit: µg micr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: It is intended to include 20 adult patients (> 18 years) diagnosed with left ventricular heart failure scheduled for LVAD. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Selenium intoxication, pregnant or lactating women, women of child-bearing age not using a suitable method of contraception, patients with severe co-morbidities (renal failure requiring dialysis, hepatic impairment defined as bilirubin > 2 mg/dl) as well as patients with known anaphylaxis against the investigational product are excluded from this clinical trial.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the effects and safety of Selenium supplementation on postoperative recovery after LVAD implant surgery.;Secondary Objective: ICU independency (freedom of life sustaining therapies e.g. ventilation); Quality of life, inflammation;Primary end point(s): composite outcome (ICU independency, independency of dialysis, circulatory support and ventilation);Timepoint(s) of evaluation of this end point: ICU discharge, hospital discharge, 28 days follow-up	—

Measure

Time frame

Main Objective: To determine the effects and safety of Selenium supplementation on postoperative recovery after LVAD implant surgery.;Secondary Objective: ICU independency (freedom of life sustaining therapies e.g. ventilation); Quality of life, inflammation;Primary end point(s): composite outcome (ICU independency, independency of dialysis, circulatory support and ventilation);Timepoint(s) of evaluation of this end point: ICU discharge, hospital discharge, 28 days follow-up

—

Secondary

Measure	Time frame
Secondary end point(s): 28 days mortality; persistent organ disfunction, aquired infectious disease, renal failure, duration on respirator, neurocognitive disorder, quality of life;Timepoint(s) of evaluation of this end point: depending on end point (up to daily), up to 28 days post implantation	—

Countries

Germany

Contacts

Public ContactClinical Trial Center Aachen

University Clinic RWTH Aachen

vdeserno@ukaachen.de492418080092

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026