High-dose Selenium Supplementation in Patients With Left Ventricular Assist

Phase 3

Completed

• Conditions: Ventricular Dysfunction, Left
• Interventions: Drug: Selenium Supplement (sodium selenite); Drug: Placebo

• Registration Number: NCT02530788
• Lead Sponsor: RWTH Aachen University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-17
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Primary Completion: 2017-07
• Study Completion: 2018-01
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Selenium Supplement (sodium selenite)	Selenium Supplement (sodium selenite)	Active arm receiving Selenium in form of sodium selenite
Placebo	Placebo	Placebo arm receiving Sodium Chloride solution

Primary Outcome Measures

Name	Time	Method
Composite Outcome: independence from specific ICU procedures	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 end of the characteristic ICU procedures): * mechanical ventilation; * vasopressor therapy; * mechanical circulatory support; * renal replacement therapy

Secondary Outcome Measures

Name	Time	Method
Incidence of nosocomial infections acquired at ICU	participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Mechanical Ventilation	participants will be followed for the duration of hospital stay, an expected average of 5-10 days	Time of mechanical ventilation (measured in hours after successful intubation) and necessity of re-intubation
Mortality	postoperative day 28	via telephone enquiry
Persistent organ dysfunction	postoperative day 7	Persistent organ dysfunction quantified upon day 7 (or upon day of discharge from hospital) with "Sequential Organ Failure Assessment Score" (SOFA), "Multiple Organ Dysfunction Score" (MODS) and "Simplified Acute Physiology Score" (SAPS), daily quantification while ICU stay
Acute renal failure	participants will be followed for the duration of hospital stay, an expected average of 5-10 days	(quantified with RIFLE score)
postoperative delirium	participants will be followed for the duration of hospital stay, an expected average of 5-10 days	Evaluation of delirium by confusion assessment method: CAM-ICU score
Selenium concentration in whole blood, activity of glutathion-peroxidase, concentration of Selenoprotein-P (Sel-P)	preoperative, by the end of surgery, on day 1, 3, 5, 7, 13, and if the patient is still in hospital, on day 28.
Quality of Life	postoperative day 28	The patients individual "Quality of Life" (pre- and postoperative) quantified with "MACNEW - Health related quality of life in heart disease - Scale" quantified postoperative upon discharge from hospital and on the 28th POD via telephone inquiry. If the patient cannot be contacted via telephone on the 28th POD, we will try to reach the patient on the following 7 days.

Trial Locations

Locations (1)

Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen; 🇩🇪 Aachen, NRW, Germany