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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003224
Receipt No. R000003905
Scientific Title Extravascular lung water in patients with Post-Cardiac Arrest Syndrome:a prospective cohort study
Date of disclosure of the study information 2010/02/21
Last modified on 2012/02/21

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Basic information
Public title Extravascular lung water in patients with Post-Cardiac Arrest Syndrome:a prospective cohort study
Acronym Extravascular lung water in patients with Post-Cardiac Arrest Syndrome
Scientific Title Extravascular lung water in patients with Post-Cardiac Arrest Syndrome:a prospective cohort study
Scientific Title:Acronym Extravascular lung water in patients with Post-Cardiac Arrest Syndrome
Region
Japan

Condition
Condition Post-Cardiac Arrest Syndrome
Classification by specialty
Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to determine the amount of Extravascular Lung Water in patients with post-cardiac arrest syndrome.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Extravascular Lung Water and Pulmonary Vascular Permeability Index obtained from the PiCCO monitoring system in patient with post-cardiac arrest syndrome
Key secondary outcomes

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 1) Patients in cardiac arrest on arrival at hospital. Regardless of the presence of recovery of spontaneous circulation (ROSC) before arrival.
2) Patients resuscitated by 2005 American Heart Association Guideline for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.
3) Regardless of existence or nonexistence of witness.
4) Regardless of with or without bystander cardiopulmonary resuscitation (CPR).
Key exclusion criteria 1) Patients aged below 15
2) Patients in cardiac arrest associated with terminal stage of cancer.
3) Patients in cardiac arrest due to cerebrovascular disease.
4) Patients in cardiac arrest due to aortic dissection or aortic aneurysm
5) Family or other agents refuse to the registry of patient.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Tagami,MD
Organization Aizu chuo hospital
Division name Department of Emergency & Critical Care Medicine
Zip code
Address 1-1 Tsuruga, Aizuwakamatsu, Fukushima, Japan
TEL 0242-25-1515
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Tagami,MD
Organization Aizu chuo hospital
Division name Department of Emergency & Critical Care Medicine
Zip code
Address 1-1 Tsuruga, Aizuwakamatsu, Fukushima, Japan
TEL 0242-25-1515
Homepage URL
Email

Sponsor
Institute Aizu chuo hospital
Institute
Department

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 会津中央病院

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 21 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 Completed
Date of protocol fixation
2008 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 09 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information We evaluate the degree of the pulmonary edema in patient with post-cardiac arrest syndrome using Extravascular Lung Water.

Management information
Registered date
2010 Year 02 Month 21 Day
Last modified on
2012 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003905

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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