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

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Green Cross Corporation
• Collaborator: Symyoo
• Treatments: Antibodies; Immunoglobulin G; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

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