Septic Shock, Severe Sepsis
Conditions
Keywords
Human Immunoglobulin G, Sepsis, Septic shock
Brief summary
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.
Detailed description
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.
Interventions
DRUGImmunoglobulin G
Immunoglobulin 1.5-2g/Kg/3days
Sponsors
Symyoo
Green Cross Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with severe sepsis or septic shock, if all of the following criteria is satisfied. 1. Age ≥ 18 years 2. Proved or suspected infection in at least one site * 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
1. Pregnant or breast-feeding women 2. a weight \> 100kg 3. discharged from the hospital at least 14 days prior to new admission 4. Transferred from another hospital staying more than 48 hours 5. allergy or shock of IVIG 6. Treated with IVIG within the 12 weeks immediately preceding enrolment in this study 7. IgA deficiency 8. Hypernatremia or hyperhydration 9. Proved or suspected HIV or AIDS patients(CD4+ \<200mL) 10. Current participation in any study within the last 4 weeks 11. Do not resuscitate (DNR) status 12. Patient's death is considered imminent due to coexisting disease 13. physicians decision to exclude patients from this protocol 14. Immunocompromised patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality | 28th day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 7th day | — |
| Course of SOFA subscores | 5 Times: D-1, D1, D3, D5, D7 | — |
| Laboratory Test | 7th Day | sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA |
| Duration of ICU and general ward admission | 28 days | — |
Countries
South Korea
Outcome results
None listed