GCIV as an Adjuvant Therapy for Community-Acquired 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.' in Adult Subjects With Community-Acquired Severe Sepsis or Septic Shock

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.

Study Overview

• Status: Terminated
• Conditions: Septic Shock; Severe Sepsis
• Intervention / Treatment: Drug: Immunoglobulin G

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.

• Study Type: Interventional
• Enrollment (Anticipated): 214
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imunoglobulin 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.	Drug: Immunoglobulin G; Immunoglobulin 1.5-2g/Kg/3days; Other Names: GCIV
Placebo Comparator: Placebo control; 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; Immunoglobulin 1.5-2g/Kg/3days; Other Names: GCIV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Collaborators: Symyoo
• Investigators: Principal Investigator: Min Ja Kim, Professor, Korea University Anam Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: March 14, 2011
• First Submitted That Met QC Criteria: March 14, 2011
• First Posted (Estimate): March 15, 2011

Study Record Updates

• Last Update Posted (Estimate): April 30, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Septic shock; Sepsis; Human Immunoglobulin G
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Immunoglobulin G
• Other Study ID Numbers: GCIV_P3