Intravenous Immunoglobulin in Combination Therapy With Antibacterial Agents for SSI of the Lower Digestive Tract

Study Overview
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Brief Summary
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The purpose of this study is to assess the clinical usefulness of IVIG in combination therapy with antibacterial agents for severe peritonitis after lower digestive tract surgery.

Official Title
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Clinical Study of Intravenous Immunoglobulin (IVIG) in Combination Therapy With Antibacterial Agents for Surgical Site Infection of the Lower Digestive Tract

Conditions
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Peritonitis, Postoperative Complications

Intervention / Treatment
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* Drug: intravenous immunoglobulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have obvious symptoms and observation of post-surgical peritonitis, and meet the criteria described bellow. Patients with >=38 degrees C, >=15,000/mm3 or <=3,000/mm3 of WBC and >=10mg/dL of CRP Patients who have no abscess on the abdominal image Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement Patients who are 20 years old or older Patients who have signed the agreement for participation in this study Exclusion Criteria: Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products Patients who have a history of shock due to any of the ingredients of Immunoglobulin products Patients who were administered immunoglobulin within 1 month before entry Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement Patients with IgA deficiency Patients with hereditary fructose intolerance Patients with history of allergy or adverse effect for antibacterial agents Patients who have underlying or concomitant disease that may seriously affect the assessment of this study Patients who are or could be pregnant Patients who have noninfectious fever, fungal infection or viral illness Other patients who are judged to be inadequate to participate in this study by their physician

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: intravenous immunoglobulin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical efficacy |  | at day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical efficacy, recurrence rate, mortality, time between drug administration and defervescence, defervescence rate,time between drug administration and disappearance of clinical symptoms, improvement rate on clinical symptoms |  | at day 3 and at the end of test drug administration, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe peritonitis, SSI, lower digestive tract surgery, Severe peritonitis after lower digestive tract surgery