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

NCT ID: NCT00511212

Last Updated: 2011-07-21

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-06-30

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.

Detailed Description

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Conditions

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Peritonitis Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intravenous immunoglobulin

Intervention Type DRUG

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.

1. Patients with \>=38 degrees C, \>=15,000/mm3 or \<=3,000/mm3 of WBC and \>=10mg/dL of CRP
2. Patients who have no abscess on the abdominal image
3. Patients who were administered antibacterial agents for 1 day or more, and show no sign of improvement
4. Patients who are 20 years old or older
5. Patients who have signed the agreement for participation in this study

Exclusion Criteria

1. Patients who have a history of hypersensitivity to any of the ingredients of Immunoglobulin products
2. Patients who have a history of shock due to any of the ingredients of Immunoglobulin products
3. Patients who were administered immunoglobulin within 1 month before entry
4. Patients who were administered antibacterial agents for 1 day or more, and show signs of improvement
5. Patients with IgA deficiency
6. Patients with hereditary fructose intolerance
7. Patients with history of allergy or adverse effect for antibacterial agents
8. Patients who have underlying or concomitant disease that may seriously affect the assessment of this study
9. Patients who are or could be pregnant
10. Patients who have noninfectious fever, fungal infection or viral illness
11. Other patients who are judged to be inadequate to participate in this study by their physician
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

OTHER

Sponsor Role lead

Principal Investigators

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Morito Monden, MD, PhD

Role: STUDY_CHAIR

Multicenter Clinical Study Group of Osaka

Locations

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Osaka University Hospital

Suita, Osaka, Japan

Site Status

Countries

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Japan

Other Identifiers

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MCSGO-0701

Identifier Type: -

Identifier Source: org_study_id

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