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Table 1 Randomized clinical trials evaluating selenium supplementation in critically ill patients

From: High-dose intravenous selenium does not improve clinical outcomes in the critically ill: a systematic review and meta-analysis

Study Population Methodology (score) Intervention
Kuklinski 1991 [38] Patients with acute pancreatic necrosis C.Random: not sure PN + selenium supplementation (500 μg/day) vs. PN without selenium supplementation
n = 17 ITT: no
Blinding: no
(4)
Zimmerman 1997 [39] Patients with SIRS, sepsis, APACHE II score >15, and multiorgan failure score >6 C.Random: no IV selenium as sodium selenite 1000 μg as a bolus and then 1000 μg sodium selenite 24 h as a continuous infusion over 28 days vs. standard
n = 40 ITT: yes
Blinding: no
(6)
Berger 1998 [40] Burns >30 % TBSA C.Random: yes IV copper (40.4 μmol), selenium (159 μg), zinc (406 μmol) + standard trace elements vs. standard trace elements (copper 20 μmol, selenium 32 μg, zinc 100 μmol) from days 0 to 8, all received early EN
n = 20 ITT: yes
Blinding: double blind
(12)
Angstwurm 1999 [41] Patients with SIRS and sepsis at 11 ICUs C.Random: not sure PN with high-dose selenium (535 μg × 3 days, 285 μg × 3 days, 155 μg × 3 days, and 35 μg thereafter) vs. low-dose selenium (35 μg/day for duration of study)
n = 42 ITT: yes
Blinding: no
(10)
Porter 1999 [42] Surgical ICU penetrating trauma patients with Injury Severity Score ≥25 C.Random: yes 50 μg selenium IV every 6 h + 400 IU vitamin E, 100 mg vitamin C every 8 h, and 8 g of N-acetylcysteine every 6 h via nasogastric or oral route from days 0 to 7 vs. none
n = 18 ITT: yes
Blinding: no
(9)
Berger 2001 [43] Trauma patients, surgical ICU C.Random: yes IV selenium supplementation (500 μg/day) vs. placebo (selenium group randomized further to two groups: 500 μg selenium alone vs. 500 μg selenium + 150 mg α-tocopherol + 13 mg zinc) given slowly for first 5 days after injury (all groups received EN)
n = 31 ITT: no
Blinding: double
(9)
Lindner 2004 [44] Patients with acute pancreatitis admitted to the ICU C.Random: not sure IV sodium selenite dose of 2000 μg on day 1, 1000 μg on days 2–5, and 300 μg from day 6 until discharge vs. placebo (isotonic 0.9 % IV NaCl solution)
n = 70 ITT: no
Blinding: single
(9)
Angstwurm 2007 [45] Multicenter mixed ICUs C.Random: not sure 1000 μg selenium IV within 1 h followed by 1000 μg selenium for 14 days vs. NaCl (0.9 %) (all patients received EN or PN)
n = 249 ITT: no
Blinding: double
(8)
Berger 2007 [46] Burns >20 % TBSA C.Random: not sure IV 100 ml of copper (59 μmol) + selenium (375 μg + zinc (574 μmol) vs. NaCl (0.9 %) from admission for 5–15 days
n = 21 ITT: yes Both groups were on EN
Blinding: no
(8)
Forceville 2007 [47] Septic shock patients C.Random: not sure 4000 μg selenium IV on day 1 followed by 1000 μg selenium for 9 days vs. NaCl (0.9 %) (all patients received EN or PN)
n = 60 ITT: no
Blinding: double
(8)
Mishra 2007 [48] Septic ICU patients C.Random: not sure 474 μg selenium IV × 3 days followed by 316 μg × 3 days, 158 μg × 3 days, and 31.6 μg thereafter vs. 31.6 μg selenium (all patients received EN or PN)
n = 40 ITT: yes
Blinding: double
(9)
Berger 2008 [49] Mixed ICU C.Random: not sure IV selenium supplementation loading dose 540 μg/day + zinc (60 mg) + vitamin C 2700 mg + vitamin B 305 mg + vitamin E enteral 600 mg + vitamin E 12.8 mg IV for 2 days followed by half the dose of all vs. standard vitamins
n = 200 ITT: yes
Blinding: no All groups received EN or PN
(10)
El-Attar 2009 [50] Patients with COPD C.Random: yes IV selenium as sodium selenite 100 μg/day, zinc 2 mg/day, and manganese 0.4 mg/day vs. none
n = 80 ITT: yes Trace elements were administered during the period on mechanical ventilation
Blinding: yes
(12)
Montoya 2009 [51] Medical/surgical septic C.Random: yes Day 1 IV sodium selenite 1000 μg , day 2 sodium selenite 500 μg, and thereafter 200 μg during 7 additional days vs. selenite 100 μg/day
ICU patients ITT: yes
n = 68 Blinding: double
(7)
Andrews 2011 [52] Mixed ICU, multicenter C.Random: yes 500 μg selenium supplemented PN (12.5 g nitrogen, 2000 kcal) vs. standard PN (12.5 g nitrogen, 2000 kcal) initiated after ICU admission (actual median 2.6 days) for 7 days (actual duration, mean 4.1 days).
n = 502 ITT: yes
Blinding: double blind
(13)
Manzanares 2011 [53] Septic or trauma patients C.Random: not sure IV selenium supplementation loading dose 2000 μg (2 h) on day 1 followed by 1600 μg/day for 10 days vs. NaCl as placebo
n = 35 ITT: no (except mortality)
Blinding: single blind
(9)
Valenta 2011 [54] Patients with sepsis or SIRS C.Random: not sure IV selenium supplementation loading dose 1000 μg on day 1 followed by 500 μg/day for 5–14 days + <75 μg/day of sodium selenite added to PN vs. NaCl + <75 μg/day of sodium selenite added to PN
n = 150 ITT: yes
Blinding: no
(8)
Heyland 2013 [16] Multicenter mixed ICUs C.Random: yes 500 μg selenium via PN + 300 μg selenium, 20 mg zinc, 10 mg β-carotene, 500 mg vitamin E, 1500 mg vitamin C via EN vs. placebo via PN and EN
n = 1218 ITT: yes
Blinding: double
(12)
Woth 2014 [14] Mixed ICU, severe septic patients with multiorgan failure C.Random: not sure 1000-μg/30 minutes loading dose of sodium selenite and 1000-μg/day treatment for a maximum of 14 days vs. control group (not described)
n = 40 ITT: yes
Blinding: no
(6)
Bloos 2016 [17] Multicenter mixed ICU patients with severe sepsis or septic shock in last 24 h C.Random: yes IV loading dose of 1000 μg sodium selenite followed by continuous IV of 1000 μg sodium selenite daily until ICU discharge or for 21 days, whichever comes first vs. placebo (NaCl)
ITT: yes
n = 1089 Blinding: double
(12)
Chelkeba 2015 [15] Mixed ICU patients with severe sepsis and septic shock C.Random: yes IV loading dose of 2000 μg sodium selenite followed by continuous IV of 1500 μg sodium selenite daily until day 14 vs. standard therapy without selenium
n = 54 ITT: no
Blinding: single
(11)
  1. Abbreviations: APACHE Acute Physiology and Chronic Health Evaluation, COPD Chronic obstructive pulmonary disease, C.Random Concealed randomization, D5W Dextrose 5 % in water, EN Enteral nutrition, ICU Intensive care unit, ITT Intention to treat, IV Intravenous, PN Parenteral nutrition, SIRS Systemic inflammatory response syndrome, TBSA Total body surface area