NCT01601938

Brief Summary

This study will be performed to determine whether selenium replacement reduces 28-day mortality of severe sepsis and septic shock patients, and to investigate whether selenium replacement contributes differently to the mortality reduction of the patients according to their initial serum selenium level.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 18, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

March 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.6 years

First QC Date

May 15, 2012

Last Update Submit

March 3, 2016

Conditions

SepsisShock, Septic

Keywords

SepsisShock, SepticSeleniumSurvival

Outcome Measures

Primary Outcomes (1)

  • 28-day mortality

    All cause mortality occurs within 28 days.

    28 days

Secondary Outcomes (11)

  • ICU length of stay

    3 months

  • Mortality at hospital discharge

    3 months

  • Development of the new infection

    3 months

  • Serum selenium level

    At 0, 24, 72, 168 hours post-enrollment

  • Ventilator days

    3 months

  • +6 more secondary outcomes

Study Arms (2)

Selenium

EXPERIMENTAL

500 mcg of selenium (10mL) daily for 7 days

Dietary Supplement: selenium replacement

Placebo

PLACEBO COMPARATOR

Placebo 10 mL (delivered from biosyn) for 7 days

Dietary Supplement: Placebo

Interventions

selenium replacementDIETARY_SUPPLEMENT

Selenium 500 mcg (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.

Also known as: Selenase T pro injectione
Selenium
PlaceboDIETARY_SUPPLEMENT

placebo (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.

Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 or older
  • clinical diagnosis of severe sepsis or septic shock

You may not qualify if:

  • pregnancy or breast feeding
  • age younger than 18
  • advanced directive state to withhold treatment
  • known allergy to selenium
  • CPR or death within 24 hours after the diagnosis of severe sepsis or septic shock
  • advanced malignancy without further treatment plan

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (3)

  • Angstwurm MW, Engelmann L, Zimmermann T, Lehmann C, Spes CH, Abel P, Strauss R, Meier-Hellmann A, Insel R, Radke J, Schuttler J, Gartner R. Selenium in Intensive Care (SIC): results of a prospective randomized, placebo-controlled, multiple-center study in patients with severe systemic inflammatory response syndrome, sepsis, and septic shock. Crit Care Med. 2007 Jan;35(1):118-26. doi: 10.1097/01.CCM.0000251124.83436.0E.

    PMID: 17095947BACKGROUND

  • Andrews PJ, Avenell A, Noble DW, Campbell MK, Croal BL, Simpson WG, Vale LD, Battison CG, Jenkinson DJ, Cook JA; Scottish Intensive care Glutamine or seleNium Evaluative Trial Trials Group. Randomised trial of glutamine, selenium, or both, to supplement parenteral nutrition for critically ill patients. BMJ. 2011 Mar 17;342:d1542. doi: 10.1136/bmj.d1542.

    PMID: 21415104BACKGROUND

  • Forceville X, Laviolle B, Annane D, Vitoux D, Bleichner G, Korach JM, Cantais E, Georges H, Soubirou JL, Combes A, Bellissant E. Effects of high doses of selenium, as sodium selenite, in septic shock: a placebo-controlled, randomized, double-blind, phase II study. Crit Care. 2007;11(4):R73. doi: 10.1186/cc5960.

    PMID: 17617901BACKGROUND

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Gil Joon Suh, professor

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 18, 2012

Study Start

September 1, 2012

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

March 4, 2016

Record last verified: 2016-03

Locations

KR(1)