GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock
NCT ID: NCT01315496
Last Updated: 2013-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
214 participants
INTERVENTIONAL
2009-10-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
Immunoglobulin G
Immunoglobulin 1.5-2g/Kg/3days
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.
Immunoglobulin G
Immunoglobulin 1.5-2g/Kg/3days
Interventions
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Immunoglobulin G
Immunoglobulin 1.5-2g/Kg/3days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Symyoo
INDUSTRY
Green Cross Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Min Ja Kim, Professor
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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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
Countries
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Other Identifiers
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GCIV_P3
Identifier Type: -
Identifier Source: org_study_id