High-dose Selenium Supplementation in Patients With Left Ventricular Assist

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RWTH Aachen University
• Collaborators: biosyn Arzneimittel GmbH; Cardiodevice Stiftung
• Treatments: Selenious Acid; Selenium; Sodium Selenite

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