Unique ID issued by UMIN | UMIN000003627 |
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Receipt number | R000004400 |
Scientific Title | Prospective multicenter study on the quantitative pathophysiological assessment of acute pulmonary edema |
Date of disclosure of the study information | 2010/05/17 |
Last modified on | 2013/11/17 09:21:28 |
Prospective multicenter study on the quantitative pathophysiological assessment of acute pulmonary edema
Prospective multicenter study on the quantitative 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
Japan |
acute pulmonary edema
Emergency medicine | Intensive care medicine |
Others
NO
The purpose of this study is to establish the quantitative differential criteria of cardiogenic edema and ALI/ARDS (permeability edema) using transpulmonary thermodilution technique monitoring. To assessed the pathophysioly of pulmonary edema, pulmonary vascular permeability index (PVPI) by extravascular lung water index (ELWI)/pulmonary blood volume index was used. Pulmonary edema was defined as ELWI >10mL/kg.
Others
To establish the quantitative criteria of cardiogenic edema and ALI/ARDS using ELWI and PVPI
Confirmatory
Pragmatic
Not applicable
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).
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
Observational
15 | years-old | <= |
Not applicable |
Male and Female
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
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
200
1st name | |
Middle name | |
Last name | Shigeki Kushimoto, M.D. |
Tohoku University Graduate School of Medicine
Division of Emergency Medicine
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
022-717-7487
1st name | |
Middle name | |
Last name | Shigeki Kushimoto, M.D. |
Tohoku University Graduate School of Medicine
Division of Emergency Medicine
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
022-717-7487
kussie@emergency-medicine.med.tohoku.ac.jp
Tohoku University Graduate School of Medicine
none
Self funding
NO
東京医科歯科大学医学部附属病院
独立行政法人国立病院機構災害医療センター
東京女子医科大学東医療センター
日本大学医学部附属板橋病院
聖マリアンナ医科大学病院
日本医科大学多摩永山病院
日本医科大学千葉北総病院
川口市立医療センター
自治医科大学附属病院
関西医科大学附属枚方病院
大阪市立総合医療センター
奈良県立医科大学附属病院
兵庫医科大学病院
神戸大学医学部附属病院
高知大学医学部附属病院
北海道大学病院
東北大学病院
福岡大学病院
健和会 大手町病院
長崎大学医学部・歯学部附属病院
久留米大学病院
名古屋大学医学部附属病院
社会保険中京病院
会津中央病院
日本医科大学付属病院
2010 | Year | 05 | Month | 17 | Day |
Published
Main results were published in the following manuscripts;
Critical Care 2012, 16:R232
Critical Care 2013; 17:R132
Critical Care 2013; 17:418
Completed
2008 | Year | 10 | Month | 13 | Day |
2009 | Year | 01 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 08 | Month | 01 | Day |
2014 | Year | 03 | Month | 31 | Day |
The cause of pulmonary edema was determined by three or more experts, taking into account medical history, clinical features, respiratory and hemodynamic variables, clinical course with therapy. Experts were blind for PVPI.
2010 | Year | 05 | Month | 17 | Day |
2013 | Year | 11 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004400
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