High-dose Selenium Supplementation in Patients With Left Ventricular Assist

NCT02530788 | Completed Phase 3 DMC

• 1 other identifier: 13-036
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Dysfunction, Left

Keywords

Heart Failure; Cardiac Surgery; Ventricular Assist Device; Selenium

Outcome Measures

Primary Outcomes (1)

• Composite Outcome: independence from specific ICU procedures

  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

  postoperative day 28

Secondary Outcomes (8)

• Mortality

  postoperative day 28

• Persistent organ dysfunction

  postoperative day 7

• Incidence of nosocomial infections acquired at ICU

  participants will be followed for the duration of hospital stay, an expected average of 5-10 days

• Acute renal failure

  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

Study Arms (2)

Selenium Supplement (sodium selenite)

ACTIVE COMPARATOR

Active arm receiving Selenium in form of sodium selenite

Drug: Selenium Supplement (sodium selenite)

Placebo

PLACEBO COMPARATOR

Placebo arm receiving Sodium Chloride solution

Drug: Placebo

Interventions

Selenium Supplement (sodium selenite) DRUG

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).

Also known as: Selenase (R) 300 RP, Selenase (R) T

Selenium Supplement (sodium selenite)

Placebo DRUG

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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead
• biosyn Arzneimittel GmbH: collaborator
• Cardiodevice Stiftung: collaborator

Study Sites (1)

Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left; Heart Failure

Interventions

Sodium Selenite

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Selenious Acid; Selenium Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Andreas Goetzenich, MD, PhD

  Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen

  PRINCIPAL INVESTIGATOR

• Christian Stoppe, MD

  Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2015
• First Posted: August 21, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

DE (1)