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Recruitment status Completed
Unique ID issued by UMIN UMIN000003627
Receipt No. 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

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Basic information
Public title Prospective multicenter study on the quantitative pathophysiological assessment of acute pulmonary edema
Acronym Prospective multicenter study on the quantitative assessment of acute pulmonary edema
Scientific Title Prospective multicenter study on the quantitative pathophysiological assessment of acute pulmonary edema
Scientific Title:Acronym Prospective multicenter study on the quantitative assessment of acute pulmonary edema
Region
Japan

Condition
Condition acute pulmonary edema
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Others
Basic objectives -Others To establish the quantitative criteria of cardiogenic edema and ALI/ARDS using ELWI and PVPI
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 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).
Key secondary outcomes 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key 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
Key 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
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Kushimoto, M.D.
Organization Tohoku University Graduate School of Medicine
Division name Division of Emergency Medicine
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL 022-717-7487
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shigeki Kushimoto, M.D.
Organization Tohoku University Graduate School of Medicine
Division name Division of Emergency Medicine
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai 980-8574, Japan
TEL 022-717-7487
Homepage URL
Email kussie@emergency-medicine.med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 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

Other administrative information
Date of disclosure of the study information
2010 Year 05 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Main results were published in the following manuscripts;
Critical Care 2012, 16:R232 
Critical Care 2013; 17:R132
Critical Care 2013; 17:418
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 10 Month 13 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 08 Month 01 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information 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.

Management information
Registered date
2010 Year 05 Month 17 Day
Last modified on
2013 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004400


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