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

Primary Purpose

Severe Sepsis, Septic Shock

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Immunoglobulin G
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring Human Immunoglobulin G, Sepsis, Septic shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Ansan Hospital
  • Hallym University Sacred Heart Hospital
  • Chungbuk National University Hospital
  • Gachon University Gil Hospital
  • Gyrongsang National University Hospital
  • Asan Medical Center
  • Ewha Womans University Mokdong Hospital
  • Kangdong Sacred Heart Hospital
  • Kangnam Sacred Heart Hospital
  • Korea University Anam Hospital
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Seoul Medical Center
  • Severance Hospital
  • The Catholic of Korea Yeouido ST. Mary's Hospital
  • Ajuo University Hospital
  • Wonju Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Imunoglobulin G

Placebo control

Arm Description

The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days.

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.

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

All cause mortality
Course of SOFA subscores
Laboratory Test
sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA
Duration of ICU and general ward admission

Full Information

First Posted
March 14, 2011
Last Updated
April 29, 2013
Sponsor
Green Cross Corporation
Collaborators
Symyoo
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1. Study Identification

Unique Protocol Identification Number
NCT01315496
Brief Title
GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Green Cross Corporation
Collaborators
Symyoo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis, Septic Shock
Keywords
Human Immunoglobulin G, Sepsis, Septic shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imunoglobulin G
Arm Type
Experimental
Arm Description
The enrolled patients will be randomized to receive supplementation of IVIG in ICU within 48 hours after hospital arrival admission for 3 consecutive days.
Arm Title
Placebo control
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Immunoglobulin G
Other Intervention Name(s)
GCIV
Intervention Description
Immunoglobulin 1.5-2g/Kg/3days
Primary Outcome Measure Information:
Title
All cause mortality
Time Frame
28th day
Secondary Outcome Measure Information:
Title
All cause mortality
Time Frame
7th day
Title
Course of SOFA subscores
Time Frame
5 Times: D-1, D1, D3, D5, D7
Title
Laboratory Test
Description
sputum culture test, CBC, blood chemistry, blood coagulation test, CRP, ABGA
Time Frame
7th Day
Title
Duration of ICU and general ward admission
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Ja Kim, Professor
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Ansan Hospital
City
Ansan
Country
Korea, Republic of
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju
Country
Korea, Republic of
Facility Name
Gachon University Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Gyrongsang National University Hospital
City
Jinju-si, Gyeongsangnam-do,
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangdong Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kangnam Sacred Heart Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic of Korea Yeouido ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajuo University Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Wonju Christian Hospital
City
Wonju
Country
Korea, Republic of

12. IPD Sharing Statement

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

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