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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Centre Hospitalier de Meaux
ClinicalTrials.gov Identifier:
NCT00207844
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

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 Intervention Phase
Septic Shock
Severe Sepsis
Drug: Selenium as sodium selenite
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier de Meaux:

Primary Outcome Measures:
  • Weaning time of catecholamines

Secondary Outcome Measures:
  • - 6 month mortality rate
  • - 6 month quality of life
  • - 28 days mortality
  • - ICU mortality
  • - Hospital mortality
  • - ICU length of stay
  • - Hospital length of stay
  • - Number of nosocomial infections in ICU
  • - Duration of ventilation
  • - SOFA score in ICU at days 4, 7, 10 and 14
  • - Oxidative stress evaluation at days 4, 7, 10 and 14
  • - Inflammation evaluation at days 4, 7, 10 and 14
  • - Selenium status
  • - Costs and work load
  • - Onset of clinical events

Estimated Enrollment: 60
Study Start Date: January 2002
Estimated Study Completion Date: January 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00207844

Locations
France
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
Investigators
Principal Investigator: Xavier Forceville, MD CH Meaux
Study Chair: Eric Bellissant, MD, PhD CHU Rennes
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00207844     History of Changes
Other Study ID Numbers: AFSSAPS 10602, CIC0203/003
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 19, 2014