UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003800
Receipt No. R000004594
Scientific Title Analysis of cardiopulmonary function after severe head injury
Date of disclosure of the study information 2010/07/01
Last modified on 2010/06/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Analysis of cardiopulmonary function after severe head injury
Acronym Analysis of cardiopulmonary function after severe head injury
Scientific Title Analysis of cardiopulmonary function after severe head injury
Scientific Title:Acronym Analysis of cardiopulmonary function after severe head injury
Region
Japan

Condition
Condition severe head injury
Classification by specialty
Neurosurgery Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Volume management is crucial in intensive care, however, in some patients it is very hard to achieve optimal water balance. Severe head injury (SHI) patient is a representative example. Cardiopulmonary complications are common after SHI: neurogenic pulmonary edema, cardiac failure, and so on. We have started controlled trial about cardiopulmonary function after SHI. In this study we will present the effects of PiCCO plus monitoring after SHI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes incidence of neurogenic pulmonary edema
Key secondary outcomes cardiac function

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Factor A
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria severe head injury (GCS<9)
Key exclusion criteria no brain stem response
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiji Isotani
Organization Tokyo medical and Dental University
Division name Department of acute critical care medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5102
Email

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Isotani
Organization Tokyo medical and Dental University
Division name Department of acute critical care medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5102
Homepage URL http://www.tmd.ac.jp/med/accm/
Email isotani.accm@tmd.ac.jp

Sponsor
Institute SHI PiCCO study group
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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 東京医科歯科大学附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 Day

Related information
URL releasing protocol http://www.tmd.ac.jp/med/accm/
Publication of results Partially published

Result
URL related to results and publications http://www.tmd.ac.jp/med/accm/
Number of participants that the trial has enrolled
Results
Output, contractility and afterload were essentially normal after SAH. Intrathoracic blood volume was slightly elevated and this fluid redistribution causes hydrostatic fluid retention in lung tissues on PiCCO monitoring after SHI. 
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 Open public recruiting
Date of protocol fixation
2008 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 10 Month 01 Day
Date trial data considered complete
2012 Year 10 Month 01 Day
Date analysis concluded
2013 Year 03 Month 01 Day

Other
Other related information Preliminary report will be announced at 38th annual meeting of Japanese Association of Acute Medicine and 69th annual meeting of Japanese Association of Neurusurgery

Management information
Registered date
2010 Year 06 Month 22 Day
Last modified on
2010 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004594

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.