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
1 other identifier
interventional
214
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2009
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 30, 2013
April 1, 2013
4.2 years
March 14, 2011
April 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All cause mortality
28th day
Secondary Outcomes (4)
All cause mortality
7th day
Course of SOFA subscores
5 Times: D-1, D1, D3, D5, D7
Laboratory Test
7th Day
Duration of ICU and general ward admission
28 days
Study Arms (2)
Imunoglobulin G
EXPERIMENTALThe enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days.
Placebo control
PLACEBO COMPARATORThe 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- +2 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Green Cross Corporationlead
- Symyoocollaborator
Study Sites (17)
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Chungbuk National University Hospital
Cheongju-si, South Korea
Gachon University Gil Hospital
Incheon, South Korea
Gyrongsang National University Hospital
Jinju-si, Gyeongsangnam-do,, South Korea
Asan Medical Center
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Kangdong Sacred Heart Hospital
Seoul, South Korea
Kangnam Sacred Heart Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
The Catholic of Korea Yeouido ST. Mary's Hospital
Seoul, South Korea
Ajuo University Hospital
Suwon, South Korea
Wonju Christian Hospital
Wŏnju, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Ja Kim, Professor
Korea University Anam Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 15, 2011
Study Start
October 1, 2009
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 30, 2013
Record last verified: 2013-04