Clinical trial NCT01601938: Selenium Replacement and Serum Selenium Level in Severe Sepsis and Septic Shock Patients
Official title: Effects of Selenium Replacement on Prognosis of Severe Sepsis and Septic Shock Patients and Their Initial Serum Selenium Level: a Randomized, Double-blind Placebo Controlled Phase 2 Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Sepsis
Shock, Septic
Keywords: Sepsis
Shock, Septic
Selenium
Survival
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Biosyn
name: Boryung Pharmaceutical Co., Ltd
First posted: 2012-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study is a single center, randomized, double-blind, placebo controlled trial.

After the diagnosis of severe sepsis and septic shock, enrolled patients will be randomized. Then, selenium or placebo will be intravenously administered to them for 7 days. Hemodynamic and laboratory data will be recorded for 7 days and additional serum samples will be obtained at 0, 24, 72, and 168 hours post-treatment and stored. Mortality will be observed for 28 days.

An interim analysis will be conducted by the independent data safety monitoring board.

Serum selenium levels will be measured from the stored serum samples after the study completion.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: 28-day mortality
timeFrame: 28 days
Secondary outcomes:
measure: ICU length of stay
timeFrame: 3 months
measure: Mortality at hospital discharge
timeFrame: 3 months
measure: Development of the new infection
timeFrame: 3 months
measure: Serum selenium level
timeFrame: At 0, 24, 72, 168 hours post-enrollment
measure: Ventilator days
timeFrame: 3 months
measure: Renal replacement therapy days
timeFrame: 3 months
measure: Oxidative stress marker
timeFrame: At 0, 24, 72, 168 hours post-enrollment
measure: Changes in severity scores
timeFrame: 7 days
measure: 3-month mortality
timeFrame: 3 months post-enrollment
measure: Inflammatory markers
timeFrame: At 0, 24, 72, 268 hours post-enrollment
measure: Vasopressor days
timeFrame: 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Gil Joon Suh, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.