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A pilot study the effectiveness of immune globulin for ALI / ARDS

A pilot study the effectiveness of immune globulin for ALI / ARDS - A pilot study the effectiveness of immune globulin for ALI / ARDS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000005422
Enrollment
10
Registered
2011-04-12
Start date
2011-03-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ALI/ARDS due to sepsis

Interventions

Freeze-Dried Sulfonated Human Normal Immunoglobulin

Sponsors

Division of Respirology, department of internal medicine, Jikei University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients clinically diagnosed as ALI / ARDS due to sepsis 2) Over 18 years of age, gender does not matter

Exclusion criteria

Exclusion criteria: 1) Patients with a history of allergy or shock to the components of the immune globulin 2) Patients with severe liver damage (for example: patients with cirrhosis), however, derived from liver failure include sepsis. 3) Patients with severe renal failure (for example: chronic dialysis patients), however, derived from kidney failure include sepsis. 4) Patients with sepsis due to hematological malignancies 5) Patients in the treatment of malignant tumors 6) Patients treated with immunosuppressive drugs such as cyclosporine 7) Patients with less than 1000 granulocytes / mm2 due to any reasons other than sepsis 8) Patients who develop chronic heart failure or acute myocardial infarction within the last six weeks 9) Patients who are judged to be inappropriate by doctor

Design outcomes

Primary

MeasureTime frame
Variation of septic inflammation markers (IL-6, TNF-a, CRP, PCT, HMGB-1, etc.)

Secondary

MeasureTime frame
1) Duration to recover from ALI/ARDS 2) Duration to recover from SIRS 3) The survival rate after 30 days 4) The period of ventilator use [VFD (Ventilator Free Days): survival time in a state that seceded from the ventilator 28 days] 5) Inspection infections (WBC, neutrophil count, the number of peripheral blood lymphocytes, the serum IgG and albumin)

Countries

Japan

Contacts

Public ContactYoshitaka Seki

Jikei University Daisan-Hospital Division of Respirology, department of internal medicine

ms97-seki@jikei.ac.jp03-3480-1151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026