UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040983
Receipt number R000046652
Scientific Title a systematic review and meta-analysis of brain natriuretic peptide and N-terminal brain natriuretic peptide for the diagnosis of cardiopulmonary edema in acute respiratory failure.
Date of disclosure of the study information 2020/07/20
Last modified on 2020/07/14 22:41:54

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Basic information

Public title

a systematic review and meta-analysis of brain natriuretic peptide and N-terminal brain natriuretic peptide for the diagnosis of cardiopulmonary edema in acute respiratory failure.

Acronym

Diagnostic test accuracy of BNP and NT_pro BNP for cardiopulmonary edema among acute respiratory failure

Scientific Title

a systematic review and meta-analysis of brain natriuretic peptide and N-terminal brain natriuretic peptide for the diagnosis of cardiopulmonary edema in acute respiratory failure.

Scientific Title:Acronym

Diagnostic test accuracy of BNP and NT_pro BNP for cardiopulmonary edema among acute respiratory failure

Region

Japan


Condition

Condition

acute respiratory failure

Classification by specialty

Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the diagnostic accuracy of the BNP and NT-proBNP for diagnosis of CPE in patients with acute respiratory failure.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the diagnostic accuracy of the BNP and NT-proBNP for diagnosis of CPE in patients with acute respiratory failure.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

120 years-old >=

Gender

Male and Female

Key inclusion criteria

The target participants are as follows; 1) Adult patients who are 15 or more years old. 2) Presentation to ED or ICU with acute respiratory failure or dyspnea. 3) Bilateral pulmonary edema is demonstrated in chest X-ray. Study that was performed to distinguish between acute respiratory distress syndrome and cardiopulmonary edema with BNP or NT-proBNP.

Key exclusion criteria

acute respiratory failure due to heart failure.

Target sample size



Research contact person

Name of lead principal investigator

1st name Takero
Middle name
Last name Terayama

Organization

National Defense Medical College

Division name

Psychiatry Department

Zip code

359-0042

Address

Namiki 3-2, Tokorozawa, Saitama, Japan

TEL

+81-4-2995-1211

Email

takero.for.medical.journal@gmail.com


Public contact

Name of contact person

1st name Takero
Middle name
Last name Terayama

Organization

National Defense Medical College

Division name

Psychiatry Department

Zip code

359-0042

Address

Namiki 3-2, Tokorozawa, Saitama, Japan

TEL

+81-4-2995-1211

Homepage URL


Email

takero.for.medical.journal@gmail.com


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

National Desenfe Medical college

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

None

Address

None

Tel

None

Email

None


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



Other administrative information

Date of disclosure of the study information

2020 Year 07 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

Preinitiation

Date of protocol fixation

2020 Year 06 Month 10 Day

Date of IRB


Anticipated trial start date

2020 Year 07 Month 09 Day

Last follow-up date

2023 Year 06 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients: acute respiratory failure, adult
Index test: BNP or NT-proBNP
Reference standard: diagnosis of experts
Target condition: cardiopulmonary edema
Objective: To determine the diagnostic accuracy of the BNP and NT-proBNP for diagnosis of CPE in patients with acute respiratory failure.
Study design: randomized controlled trial or observational study.


Management information

Registered date

2020 Year 07 Month 02 Day

Last modified on

2020 Year 07 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046652


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name