| 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. | |
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MedLine Citation:
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PMID: 17095947 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: Sepsis is associated with an increase in reactive oxygen species and low endogenous antioxidative capacity. We postulated that high-dose supplementation of sodium-selenite would improve the outcome of patients with severe sepsis and septic shock. DESIGN: Prospective randomized, placebo-controlled, multiple-center trial. SETTING: Eleven intensive care units in Germany. PATIENTS: Patients were 249 patients with severe systemic inflammatory response syndrome, sepsis, and septic shock and an Acute Physiology and Chronic Health Evaluation (APACHE) III score >70. INTERVENTIONS: Patients received 1000 microg of sodium-selenite as a 30-min bolus injection, followed by 14 daily continuous infusions of 1000 microg intravenously, or placebo. MEASUREMENTS AND MAIN RESULTS: The primary end point was 28-day mortality; secondary end points were survival time and clinical course of APACHE III and logistic organ dysfunction system scores. In addition, selenium levels in serum, whole blood, and urine as well as serum glutathione-peroxidase-3 activity were measured. From 249 patients included, 11 patients had to be excluded. The intention-to-treat analysis of the remaining 238 patients revealed a mortality rate of 50.0% in the placebo group and 39.7% in the selenium-treated group (p = .109; odds ratio, 0.66; confidence interval, 0.39-1.1). A further 49 patients had to be excluded before the final analysis because of severe violations of the study protocol. In the remaining 92 patients of the study group, the 28-day mortality rate was significantly reduced to 42.4% compared with 56.7% in 97 patients of the placebo group (p = .049, odds ratio, 0.56; confidence interval, 0.32-1.00). In predefined subgroup analyses, the mortality rate was significantly reduced in patients with septic shock with disseminated intravascular coagulation (n = 82, p = .018) as well as in the most critically ill patients with an APACHE III score > or =102 (>75% quartile, n = 54, p = .040) or in patients with more than three organ dysfunctions (n = 83, p = .039). Whole blood selenium concentrations and glutathione peroxidase-3 activity were within the upper normal range during selenium treatment, whereas they remained significantly low in the placebo group. There were no side effects observed due to high-dose sodium-selenite treatment. CONCLUSIONS: The adjuvant treatment of patients with high-dose sodium-selenite reduces mortality rate in patients with severe sepsis or septic shock. |
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Authors:
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Matthias W A Angstwurm; Lothar Engelmann; Thomas Zimmermann; Christian Lehmann; Christoph H Spes; Peter Abel; Richard Strauss; Andreas Meier-Hellmann; Rudolf Insel; Joachim Radke; Jürgen Schüttler; Roland Gärtner |
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Publication Detail:
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Type: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Critical care medicine Volume: 35 ISSN: 0090-3493 ISO Abbreviation: Crit. Care Med. Publication Date: 2007 Jan |
Date Detail:
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Created Date: 2007-01-01 Completed Date: 2007-01-19 Revised Date: 2008-02-26 |
Medline Journal Info:
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Nlm Unique ID: 0355501 Medline TA: Crit Care Med Country: United States |
Other Details:
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Languages: eng Pagination: 118-26 Citation Subset: AIM; IM |
Affiliation:
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Medizinische Klinik Innenstadt, Ludwig-Maximilians Universität München, Münich, Germany. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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APACHE Adult Aged Aged, 80 and over Disseminated Intravascular Coagulation / etiology Double-Blind Method Drug Monitoring Female Germany / epidemiology Glutathione Peroxidase / blood Hospital Mortality Humans Infusions, Intravenous Kaplan-Meiers Estimate Male Middle Aged Multiple Organ Failure / etiology Prospective Studies Sepsis / complications, drug therapy*, metabolism, mortality Severity of Illness Index Shock, Septic / complications, drug therapy*, metabolism, mortality Sodium Selenite / metabolism, pharmacology, therapeutic use* Survival Rate Systemic Inflammatory Response Syndrome / complications, drug therapy*, metabolism, mortality Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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10102-18-8/Sodium Selenite; EC 1.11.1.-/GPX3 protein, human; EC 1.11.1.9/Glutathione Peroxidase |
| Comments/Corrections | |
Comment In:
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Crit Care Med. 2008 Feb;36(2):656-7; author reply 657
[PMID:
18216642
]
Crit Care Med. 2007 Jan;35(1):306-7 [PMID: 17197777 ] Crit Care Med. 2007 Mar;35(3):995-6; author reply 996-7 [PMID: 17421119 ] Crit Care Med. 2007 Jul;35(7):1802-3 [PMID: 17581380 ] Crit Care Med. 2007 Jul;35(7):1812 [PMID: 17581398 ] |
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