Effects of High-dose Intravenous Selenium (Selenase®) in Adult Patients Subjected to Elective All-cause Heart Surgery

NCT01141556 | Completed Phase 3

• 1 other identifier: 236/09
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 3

Brief Summary

Selenoenzymes play a major role in protecting cells against lipid peroxidation and they are involved in the inflammatory response regulation. The degree of selenium deficiency correlates with disease severity and the incidence of mortality in critically ill patients. The aim of our study is to evaluate, if high dosis selenium supplementation (loading dose 4000 μg, daily dosage 1000 μg) results in a significant reduction of inflammation-induced organ dysfunction and length of ICU-stay in patients after heart surgery.

Conditions

Heart; Surgery, Heart, Functional Disturbance as Result; Self Efficacy

Keywords

selenium; clinical outcome; heart surgery

Outcome Measures

Primary Outcomes (1)

• Clinical outcome quantified by using the Sequential Organ Failure Assessment (SOFA) Score

  3 days

Secondary Outcomes (4)

• length of ICU stay in hours

  outcome at 28 days

• incidence of acute renal failure

  28 days

• total requirement of vasoconstrictors

  28 days

• total requirement of fluid replacement therapy

  28 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo (NaCl) i.v. intraoperatively, followed by an daily bolus of Placebo (NaCl) i.v. until discharge from ICU (no longer than 13 days)

Drug: Selenase

Selenase

ACTIVE COMPARATOR

Selenase Bolus 4000 microgram i.v. intraoperatively, followed by an daily bolus of Selenase 1000 microgram i.v. until discharge from ICU (no longer than 13 days)

Drug: Selenase

Interventions

Selenase DRUG

After enrollment, patients will be prospectively randomized into two groups: a placebo group without selenium and a group receiving a loading dose of selenium 4000 μg intraoperatively,followed by a daily dosage of 1000 μg until leaving the ICU (longest supplementation 13 days).

Also known as: Selenase: Selenium

Placebo; Selenase

Eligibility Criteria

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

You may qualify if:

• written informed consent
• males and females age ≥ 18 years
• patients undergoing an elective heart surgery
• normal renal function (serum creatinine ≤ 200 μmol/l)

You may not qualify if:

• pregnancy
• lack of written concent
• emergency operation

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (3)

Kantonsspital Luzern

Lucerne, Canton of Lucerne, 6016, Switzerland

Location

Departement of Anaesthesia and Intensive Care, University Hospital of Basel

Basel, Switzerland

Location

Kantonsspital Luzern

Lucerne, 6016, Switzerland

Location

Related Publications (1)

• Schmidt T, Pargger H, Seeberger E, Eckhart F, von Felten S, Haberthur C. Effect of high-dose sodium selenite in cardiac surgery patients: A randomized controlled bi-center trial. Clin Nutr. 2018 Aug;37(4):1172-1180. doi: 10.1016/j.clnu.2017.04.019. Epub 2017 May 2.

  PMID: 28502744 DERIVED

Study Officials

• Christoph Haberthuer, MD

  Anästhesie/chirurgische Intensivstation Luzerner Kantonsspital

  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: June 8, 2010
• First Posted: June 10, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

CH (3)