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

This study has been terminated.
Sponsor:
Collaborator:
Symyoo
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01315496
First received: March 14, 2011
Last updated: April 29, 2013
Last verified: April 2013

March 14, 2011
April 29, 2013
October 2009
December 2013   (final data collection date for primary outcome measure)
All cause mortality [ Time Frame: 28th day ] [ Designated as safety issue: Yes ]
Mortality [ Time Frame: 28th day ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01315496 on ClinicalTrials.gov Archive Site
  • All cause mortality [ Time Frame: 7th day ] [ Designated as safety issue: Yes ]
  • Course of SOFA subscores [ Time Frame: 5 Times: D-1, D1, D3, D5, D7 ] [ Designated as safety issue: Yes ]
  • Laboratory Test [ Time Frame: 7th Day ] [ Designated as safety issue: Yes ]
    sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA
  • Duration of ICU and general ward admission [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 7th day ] [ Designated as safety issue: Yes ]
  • Course of SOFA subscores [ Time Frame: 5 Times: D-1, D1, D3, D5, D7 ] [ Designated as safety issue: Yes ]
  • Laboratory Test [ Time Frame: 7th Day ] [ Designated as safety issue: Yes ]
    sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA
  • Duration of ICU and general ward admission [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Severe Sepsis
  • Septic Shock
Drug: Immunoglobulin G
Immunoglobulin 1.5-2g/Kg/3days
Other Name: GCIV
  • 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.
    Intervention: Drug: Immunoglobulin G
  • 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.
    Intervention: Drug: Immunoglobulin G
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
214
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01315496
GCIV_P3
No
Green Cross Corporation
Green Cross Corporation
Symyoo
Principal Investigator: Min Ja Kim, Professor Korea University Anam Hospital
Green Cross Corporation
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP