This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.
A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S inj.(Human Immunoglobulin G)' as an Adjuvant Therapy in Adult Subjects with Community-Acquired Severe Sepsis or Septic Shock.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
214
Immunoglobulin 1.5-2g/Kg/3days
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Chungbuk National University Hospital
All cause mortality
Time frame: 28th day
All cause mortality
Time frame: 7th day
Course of SOFA subscores
Time frame: 5 Times: D-1, D1, D3, D5, D7
Laboratory Test
sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA
Time frame: 7th Day
Duration of ICU and general ward admission
Time frame: 28 days
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Cheongju-si, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Gyrongsang National University Hospital
Jinju-si, Gyeongsangnam-do,, South Korea
Asan Medical Center
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Kangdong Sacred Heart Hospital
Seoul, South Korea
Kangnam Sacred Heart Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
...and 7 more locations