UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003627
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

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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


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



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 or person

Institute

Tohoku University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004400


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name