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

RWTH Aachen University

Status and phase: Completed; Phase 3

Conditions: Ventricular Dysfunction, Left

Treatments: Drug: Placebo; Drug: Selenium Supplement (sodium selenite)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02530788

13-036

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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21 participants in 2 patient groups, including a placebo group

Selenium Supplement (sodium selenite)

Active Comparator group

Description:

Active arm receiving Selenium in form of sodium selenite

Treatment:

Drug: Selenium Supplement (sodium selenite)

Placebo

Placebo Comparator group

Description:

Placebo arm receiving Sodium Chloride solution

Treatment:

Drug: Placebo