UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003800 |
|---|---|
| Receipt number | 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 17:13:07 |
* 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
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/
isotani.accm@tmd.ac.jp
Sponsor or person
Institute
SHI PiCCO study group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
