Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Symyoo | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imunoglobulin G | Experimental | The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days. |
|
| Placebo control | Placebo Comparator | The enrolled patients will be randomized to receive supplementation of placebo (0.9% NaCl) in ICU within 48 hours after hospital arrival admission for 3 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunoglobulin G | Drug | Immunoglobulin 1.5-2g/Kg/3days |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 28th day |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | 7th day | |
| Course of SOFA subscores | 5 Times: D-1, D1, D3, D5, D7 | |
| Laboratory Test |
Not provided
Inclusion Criteria:
Patients with severe sepsis or septic shock, if all of the following criteria is satisfied.
pneumonia
urinary tract infection
intra-abdominal infection
primary bloodstream infection
skin and soft tissue infection 3. Three or more of the following
a core temperature ≥ 38° C or ≤ 36° C
a heart rate ≥ 90 beats/min
a respiratory rate ≥ 20 breaths/min or PaCO2 ≤ 32 mmHg or use of mechanical ventilation for an acute process
a white blood cell count ≥ 12000/mm3 or ≤ 4000/ mm3 or immature neutrophils > 10% 4. Acute organ failure in one or more of the following
kidney
respiratory system
blood system
metabolic system
circulatory system 5. APACHE score ≥ 20 and ≤ 29 6. Patient can treatment with GCIV in ICU within at least 48 hours 7. Informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Min Ja Kim, Professor | Korea University Anam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | South Korea | ||||
| Hallym University Sacred Heart Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA
| 7th Day |
| Duration of ICU and general ward admission | 28 days |
| Anyang |
| South Korea |
| Chungbuk National University Hospital | 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 |
| Korea University Guro Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul Medical Center | Seoul | South Korea |
| Severance Hospital | Seoul | South Korea |
| The Catholic of Korea Yeouido ST. Mary's Hospital | Seoul | South Korea |
| Ajuo University Hospital | Suwon | South Korea |
| Wonju Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
Not provided
Not provided
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided