NCT02530788: SOS-LVAD

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

Completed Phase 3 Last updated 6 February 2018

What this trial tests

Phase 3 trial testing Selenium Supplement (sodium selenite) in Ventricular Dysfunction, Left in 21 participants. Completed in 1 January 2018.

Timeline

1 August 2015

Primary endpoint
1 July 2017

1 January 2018

Quick facts

Lead sponsor	RWTH Aachen University
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	21
Start date	1 August 2015
Primary completion	1 July 2017
Estimated completion	1 January 2018
Sites	1 location across Germany

Drugs / interventions tested

• Selenium Supplement (sodium selenite) — full drug profile →
• Placebo

Conditions studied

• Ventricular Dysfunction, Left — all drugs for Ventricular Dysfunction, Left →

Sponsor

RWTH Aachen University

Who can join

18 and older, any sex, with Ventricular Dysfunction, Left. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Composite Outcome: independence from specific ICU procedures
  Time frame: postoperative day 28
  As primary outcome, the investigators have chosen a composite outcome. This allows to assess the postoperative process of the included patients irrespective of extrinsic sources of irritation (e.g. daily routine, clinic based processes). The independency from specific ICU procedures is taken as a primary target (time is taken from postoperative admission to ICU after implantation of LVAD until the

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Selenoprotein P as Biomarker of Selenium Status in Clinical Trials with Therapeutic Dosages of Selenite.
   Brodin O, Hackler J, Misra S, Wendt S, et al · · 2020 · cited 52× · PMID 32290626 · DOI 10.3390/nu12041067
2. Selenium compounds for cancer prevention and therapy - human clinical trial considerations.
   Lü J, Jiang C, Hu H. · · 2025 · PMID 40600186 · DOI 10.1515/mr-2024-0065