Selenium, as Sodium Selenite, in the Treatment of Septic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00207844
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : September 21, 2005
Ministry of Health, France
Information provided by:
Centre Hospitalier de Meaux

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.

Condition or disease Intervention/treatment Phase
Septic Shock Severe Sepsis Drug: Selenium as sodium selenite Phase 2

Detailed Description:

Septic shock - an uncontrolled systemic host response to invasive infection -, leading to multiple organ failure, is a public health issue because of its frequency (> 1/1000 inhabitants per year), its cost and its 45% mortality rate, remaining high despite all the improvements made in ICU for the past 20 years. His physiopathology is better understood with increasing data supporting the key role of free radicals, and a more than 40% plasma selenium concentration decrease that maybe associated with increased morbidity and mortality. Meanwhile, for the past 30 years, researches have been conducted on the essential trace element selenium for its requirement for key antioxidant enzymes, through the 21st aa selenocystein, and also for its potentially toxic, pro-oxidant properties. In septic shock, both properties may be useful, antioxidant enzymatic to increase cell defense especially endothelial cells, and direct pro-oxidant action to decrease the genomic response, especially on phagocytic cells.

The objective of this study is to evaluate the effects of a high dose of selenium administration, such as selenite, at pro-oxydant initial dose followed by anti-oxidant dose in severe septic shock patients with documented infection. The initial dose was chosen as the highest dose of selenium, as sodium selenite, estimated without severe adverse effects in healthy people for a one-day ingestion. The patients are randomized to receive either the placebo or the selenite at this high initial dose followed by lower doses on a 9-day period. The efficacy will be evaluated by the weaning time of catecholamines, with a special attention to the 6-month mortality rate as first secondary end point.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of a Therapeutic Administration of Selenium, as Selenite, in Septic Shock Patients.
Study Start Date : January 2002
Estimated Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Primary Outcome Measures :
  1. Weaning time of catecholamines

Secondary Outcome Measures :
  1. - 6 month mortality rate
  2. - 6 month quality of life
  3. - 28 days mortality
  4. - ICU mortality
  5. - Hospital mortality
  6. - ICU length of stay
  7. - Hospital length of stay
  8. - Number of nosocomial infections in ICU
  9. - Duration of ventilation
  10. - SOFA score in ICU at days 4, 7, 10 and 14
  11. - Oxidative stress evaluation at days 4, 7, 10 and 14
  12. - Inflammation evaluation at days 4, 7, 10 and 14
  13. - Selenium status
  14. - Costs and work load
  15. - Onset of clinical events

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hospitalization in ICU
  • Severe documented infection
  • Ventilation
  • Circulatory failure requiring high dose of catecholamine
  • IGS II score >25 at inclusion
  • Informed written consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00207844

Service de Réanimation - Centre Hospitalier Victor Dupouy
Argenteuil, France, 95107
Service de Réanimation Polyvalente - CH de Châlons
Châlons-en-Champagne, France, 51000
Service de Réanimation Médicale - Hôpital Raymond Poincaré
Garches, France, 92380
Service de Réanimation - HIA Desgenettes
Lyon, France, 69275
Service de Réanimation Polyvalente - Hôpital Saint Faron
Meaux, France, 77104
Service Réanimation - HIA Saint Anne
Toulon, France, 83800
Service de Réanimation - Centre Hospitalier G. Dron
Tourcoing, France, 59208
Sponsors and Collaborators
Centre Hospitalier de Meaux
Ministry of Health, France
Principal Investigator: Xavier Forceville, MD CH Meaux
Study Chair: Eric Bellissant, MD, PhD CHU Rennes

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00207844     History of Changes
Other Study ID Numbers: AFSSAPS 10602
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: September 21, 2005
Last Verified: September 2005

Keywords provided by Centre Hospitalier de Meaux:
Oxidative stress
Septic shock
Sodium selenite

Additional relevant MeSH terms:
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Selenious Acid
Sodium Selenite
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances