NCT00207844

Brief Summary

Septic shock is a frequent syndrome with a 45% mortality rate despite intensive care unit (ICU) care, where free radicals may play a key role, and a \>40% decrease in plasma selenium concentration is observed. Selenium is a trace element with both indirect enzymatic anti-oxidant, and direct oxidant properties. High dose of sodium selenite administration could increase antioxidant cells capacities, and reduce inflammation by a direct paradoxical pro-oxidative effect. We conduct a study to evaluate the effects of selenium treatment in comparison to placebo, in septic shock patients. Efficacy will be evaluated by the weaning time of catecholamines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2002

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

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

Study Start

First participant enrolled

January 1, 2002

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

September 13, 2005

Conditions

Septic ShockSevere Sepsis

Keywords

SeleniumOxidative stressSeptic shockSodium selenite

Outcome Measures

Primary Outcomes (1)

  • Weaning time of catecholamines

Secondary Outcomes (15)

  • - 6 month mortality rate

  • - 6 month quality of life

  • - 28 days mortality

  • - ICU mortality

  • - Hospital mortality

  • +10 more secondary outcomes

Interventions

Selenium as sodium seleniteDRUG

Eligibility Criteria

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

You may qualify if:

  • Hospitalization in ICU
  • Severe documented infection
  • Ventilation
  • Circulatory failure requiring high dose of catecholamine
  • Informed written consent

You may not qualify if:

  • Pregnancy
  • End phase chronic disease
  • Limitation of care
  • Shock due to an urinary infection without bacteriemia
  • Peritonitis related to peritoneal dialysis or trauma
  • Preliminary circulatory failure
  • Participating to another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Service de Réanimation - Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Service de Réanimation Polyvalente - CH de Châlons

Châlons-en-Champagne, 51000, France

Location

Service de Réanimation Médicale - Hôpital Raymond Poincaré

Garches, 92380, France

Location

Service de Réanimation - HIA Desgenettes

Lyon, 69275, France

Location

Service de Réanimation Polyvalente - Hôpital Saint Faron

Meaux, 77104, France

Location

Service Réanimation - HIA Saint Anne

Toulon, 83800, France

Location

Service de Réanimation - Centre Hospitalier G. Dron

Tourcoing, 59208, France

Location

Related Publications (5)

  • Brun-Buisson C, Doyon F, Carlet J, Dellamonica P, Gouin F, Lepoutre A, Mercier JC, Offenstadt G, Regnier B. Incidence, risk factors, and outcome of severe sepsis and septic shock in adults. A multicenter prospective study in intensive care units. French ICU Group for Severe Sepsis. JAMA. 1995 Sep 27;274(12):968-74.

    PMID: 7674528BACKGROUND

  • Forceville X, Vitoux D, Gauzit R, Combes A, Lahilaire P, Chappuis P. Selenium, systemic immune response syndrome, sepsis, and outcome in critically ill patients. Crit Care Med. 1998 Sep;26(9):1536-44. doi: 10.1097/00003246-199809000-00021.

    PMID: 9751590BACKGROUND

  • Goode HF, Webster NR. Free radicals and antioxidants in sepsis. Crit Care Med. 1993 Nov;21(11):1770-6. doi: 10.1097/00003246-199311000-00029.

    PMID: 8222696BACKGROUND

  • Novelli GP. Role of free radicals in septic shock. J Physiol Pharmacol. 1997 Dec;48(4):517-27.

    PMID: 9444605BACKGROUND

  • 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: 17617901DERIVED

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

SeleniumSodium Selenite

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsMineralsSelenious AcidSelenium CompoundsSodium Compounds

Study Officials

  • Xavier Forceville, MD

    CH Meaux

    PRINCIPAL INVESTIGATOR

  • Eric Bellissant, MD, PhD

    CHU Rennes

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2002

Study Completion

January 1, 2005

Last Updated

September 21, 2005

Record last verified: 2005-09

Locations

FR(7)