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Selenium Replacement and Serum Selenium Level in Severe Sepsis and Septic Shock Patients (SEREAL)

This study is not yet open for participant recruitment.
Verified August 2012 by Seoul National University Hospital
Sponsor:
Collaborators:
Biosyn
Boryung Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Gil Joon Suh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01601938
First received: May 15, 2012
Last updated: August 23, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sepsis
Shock, Septic
 Dietary Supplement: selenium replacement
Dietary Supplement: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 28-day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    All cause mortality occurs within 28 days.


Secondary Outcome Measures:
  • ICU length of stay [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    After 3 months from enrollment, the participant's ICU length of stay will be evaluated.

  • Mortality at hospital discharge [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    After 3 months from enrollment, the participant's in hospital mortality will be evaluated.

  • Development of the new infection [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    After 3 months from enrollment, the development of new infection of the participant during the hospitalization will be evaluated.

  • Serum selenium level [ Time Frame: At 0, 24, 72, 168 hours post-enrollment ] [ Designated as safety issue: No ]
    After study completion, serum selenium level will be measured from stored samples. Then, we will investigate whether selenium replacement contributes differently to the mortality reduction of the enrolled patients according to their initial serum selenium level.

  • Ventilator days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    After 3 months from enrollment, total numbers of ventilator days of the participant during the hospitalization will be evaluated.

  • Renal replacement therapy days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    After 3 months from enrollment, the days of renal replacement therapy of the participant during the hospitalization will be evaluated.

  • Oxidative stress marker [ Time Frame: At 0, 24, 72, 168 hours post-enrollment ] [ Designated as safety issue: No ]
    After study completion, serum glutathione peroxidase, reduced glutathione, NADPH, and MDA will be measured from stored samples.

  • Changes in severity scores [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    APACHE II score, SOFA score, and SAPS II will be calculated at 1, 3, 7 days

  • 3-month mortality [ Time Frame: 3 months post-enrollment ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: At 0, 24, 72, 268 hours post-enrollment ] [ Designated as safety issue: No ]
    After study completion, serum cytokines, CRP, and chemokines will be measured from stored samples.

  • Vasopressor days [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Days of dopamine, norepinephrine, dobutamine, vasopressin, and epinephrine will be investigated


Estimated Enrollment: 294
Study Start Date: September 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Selenium
500 mcg of selenium (10mL) daily for 7 days
 Dietary Supplement: selenium replacement
Selenium 500 mcg (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.
Other Name: Selenase T pro injectione
Placebo Comparator: Placebo
Placebo 10 mL (delivered from biosyn) for 7 days
 Dietary Supplement: Placebo
placebo (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.
Other Name: Normal saline

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601938

Contacts
Contact: Gil Joon Suh, professor 82-2-2072-2196 suhgil@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of, 110-744
Contact: Gil Joon Suh, professor     82-2-2072-2196     suhgil@snu.ac.kr    
Sponsors and Collaborators
Gil Joon Suh
Biosyn
Boryung Pharmaceutical Co., Ltd
Investigators
Principal Investigator: Gil Joon Suh, professor Seoul National University Hospital
  More Information

Additional Information:
Our preliminary observational study which shows low serum selenium level was associated with poor prognosis of patients with septic shock in Korea.  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Gil Joon Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01601938     History of Changes
Other Study ID Numbers: SNUHEM-SEREAL-12-0001
Study First Received: May 15, 2012
Last Updated: August 23, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Sepsis
Shock, Septic
Selenium
Survival

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
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 May 16, 2013