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

Phase 3

Terminated

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.

Recruitment & Eligibility

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

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

Arm && Interventions

Group	Intervention	Description
Placebo control	Immunoglobulin G	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.
Imunoglobulin G	Immunoglobulin G	The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days.

Primary Outcome Measures

Name	Time	Method
All cause mortality	28th day

Secondary Outcome Measures

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

Locations (17): Kangdong Sacred Heart Hospital
🇰🇷
Seoul, Korea, Republic of
Gyrongsang National University Hospital
🇰🇷
Jinju-si, Gyeongsangnam-do,, Korea, Republic of
Kangnam Sacred Heart Hospital
🇰🇷
Seoul, Korea, Republic of
The Catholic of Korea Yeouido ST. Mary's Hospital
🇰🇷
Seoul, Korea, Republic of
Gachon University Gil Hospital
🇰🇷
Incheon, Korea, Republic of
Korea University Anam Hospital
🇰🇷
Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
Asan Medical Center
🇰🇷
Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital
🇰🇷
Seoul, Korea, Republic of
Wonju Christian Hospital
🇰🇷
Wonju, Korea, Republic of
Ajuo University Hospital
🇰🇷
Suwon, Korea, Republic of
Korea University Ansan Hospital
🇰🇷
Ansan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷
Anyang, Korea, Republic of
Chungbuk National University Hospital
🇰🇷
Cheongju, Korea, Republic of
Korea University Guro Hospital
🇰🇷
Seoul, Korea, Republic of
Severance Hospital
🇰🇷
Seoul, Korea, Republic of
Seoul Medical Center
🇰🇷
Seoul, Korea, Republic of