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| Name | Class |
|---|---|
| Biosyn | INDUSTRY |
| Boryung Pharmaceutical Co., Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selenium | Experimental | 500 mcg of selenium (10mL) daily for 7 days |
|
| Placebo | Placebo Comparator | Placebo 10 mL (delivered from biosyn) for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selenium replacement | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | All cause mortality occurs within 28 days. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| ICU length of stay | After 3 months from enrollment, the participant's ICU length of stay will be evaluated. | 3 months |
| Mortality at hospital discharge | After 3 months from enrollment, the participant's in hospital mortality will be evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gil Joon Suh, professor | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17095947 | Background | 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. | |
| 21415104 |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Placebo | Dietary Supplement | 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. |
|
|
| 3 months |
| Development of the new infection | After 3 months from enrollment, the development of new infection of the participant during the hospitalization will be evaluated. | 3 months |
| Serum selenium level | 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. | At 0, 24, 72, 168 hours post-enrollment |
| Ventilator days | After 3 months from enrollment, total numbers of ventilator days of the participant during the hospitalization will be evaluated. | 3 months |
| Renal replacement therapy days | After 3 months from enrollment, the days of renal replacement therapy of the participant during the hospitalization will be evaluated. | 3 months |
| Oxidative stress marker | After study completion, serum glutathione peroxidase, reduced glutathione, NADPH, and MDA will be measured from stored samples. | At 0, 24, 72, 168 hours post-enrollment |
| Changes in severity scores | APACHE II score, SOFA score, and SAPS II will be calculated at 1, 3, 7 days | 7 days |
| 3-month mortality | 3 months post-enrollment |
| Inflammatory markers | After study completion, serum cytokines, CRP, and chemokines will be measured from stored samples. | At 0, 24, 72, 268 hours post-enrollment |
| Vasopressor days | Days of dopamine, norepinephrine, dobutamine, vasopressin, and epinephrine will be investigated | 3 months |
| Background |
| 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. |
| 17617901 | Background | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |