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Prospective multicenter study on the quantitative pathophysiological assessment of acute pulmonary edema

Prospective multicenter study on the quantitative pathophysiological assessment of acute pulmonary edema - Prospective multicenter study on the quantitative assessment of acute pulmonary edema

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000003627
Enrollment
200
Registered
2010-05-17
Start date
2009-01-01
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

acute pulmonary edema

Interventions

None listed

Sponsors

Tohoku University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients ventilated (expected over 48 hours) for acute respiratory failure with P/F ratio <300 and bilateral infiltration on chest radiograph requiring transpulmonary thermodilution technique monitoring

Exclusion criteria

Exclusion criteria: 1) Over 5 days from the onset of acute respiratory failure with PaO2 /FIO2 ratio < 300 2) Chronic respiratory insufficiency (COPD, et al) 3) After pulmonary resection / pneumonectomy 4) Pulmonary thromboembolism 5) Severe peripheral arterial disease (ASO, et al) 6) Cardiogenic shock with cardiac index < 1.5 L/min/m2 7) Inappropriate for evaluation with transpulmonary thermodilution technique 8) Attending physician's decision for inappropriateness for inclusion

Design outcomes

Primary

MeasureTime frame
To establish the quantitative differential criteria of cardiogenic edema and ALI/ARDS (permeability edema), using pulmonary vascular permeability index (PVPI) and extravascular lung water index (ELWI).

Secondary

MeasureTime frame
1) Effects of serum albumin level and osmolarity on ELWI 2) Assessment of the relationship between PVPI and capillary leak index 3) Effect of selective neutrophil elastase inhibitor on patients with acute pulmonary edema 4) Assessment of severity and prognosis using ELWI, PVPI, and plasma antithrombin activity 5) Prognostic value of ELWI calculated from predicted body weight 6) Differences of EVLW and PVPI between direct and indirect injury 7) Relationship between serum BNP, NT-proBNP, creatinine and ELWI, PVPI. 8) Relationship between DIC and ELWI, PVPI 9) Relationship between ELWI, PVPI and 28-day mortarityl, period of time on mechanical ventilation. 10) Relationship between ELWI, PVPI measured at the onset of acute pulmonary edema and quasi-static lung compliance, PEEP level. 11)Relationship between procalcitonin, acutephase reactants and ELWI, PVPI

Countries

Japan

Contacts

Public ContactShigeki Kushimoto, M.D.

Tohoku University Graduate School of Medicine Division of Emergency Medicine

kussie@emergency-medicine.med.tohoku.ac.jp022-717-7487

Outcome results

None listed

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