UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003224 |
|---|---|
| Receipt number | 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 09:25:08 |
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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
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
Sponsor or person
Institute
Aizu chuo hospital
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003905
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
