NCT02530788

High-dose Selenium Supplementation in Patients With Left Ventricular Assist

Perioperative High-dose Selenium Supplementation in Patients With Left Ventricular Assist Device - a Double Blinded Randomised Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: RWTH Aachen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventricular Dysfunction, Left

Interventions

Type	Name	Description
DRUG	Selenium Supplement (sodium selenite)	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).
DRUG	Placebo	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).

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-07-01
• Completion: 2018-01-01
• First posted: 2015-08-21
• Last updated: 2018-02-07

Locations

1 site across 1 country: Germany