GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.' in Adult Subjects With Community-Acquired Severe Sepsis or Septic Shock

Conditions
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Severe Sepsis, Septic Shock

Intervention / Treatment
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* Drug: Immunoglobulin G


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with severe sepsis or septic shock, if all of the following criteria is satisfied. Age ≥ 18 years 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: Pregnant or breast-feeding women a weight > 100kg discharged from the hospital at least 14 days prior to new admission Transferred from another hospital staying more than 48 hours allergy or shock of IVIG Treated with IVIG within the 12 weeks immediately preceding enrolment in this study IgA deficiency Hypernatremia or hyperhydration Proved or suspected HIV or AIDS patients(CD4+ <200mL) Current participation in any study within the last 4 weeks Do not resuscitate (DNR) status Patient's death is considered imminent due to coexisting disease physicians decision to exclude patients from this protocol Immunocompromised patients

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imunoglobulin G<br>The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days. | Drug: Immunoglobulin G<br>* Immunoglobulin 1.5-2g/Kg/3days<br>* Other names: GCIV;|
| Placebo Comparator: Placebo control<br>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. | Drug: Immunoglobulin G<br>* Immunoglobulin 1.5-2g/Kg/3days<br>* Other names: GCIV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 28th day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | 7th day | 
| Course of SOFA subscores |  | 5 Times: D-1, D1, D3, D5, D7 | 
| Laboratory Test | sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA | 7th Day | 
| Duration of ICU and general ward admission |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunoglobulin G, Sepsis, Septic shock