UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015658 |
|---|---|
| Receipt number | R000018164 |
| Scientific Title | Prediction of neurological prognosis by automated quantitative pupillometry in post resuscitation patients |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2019/11/15 12:29:16 |
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Basic information
Public title
Prediction of neurological prognosis by automated quantitative pupillometry in post resuscitation patients
Acronym
Pupil reaction in postresuscitation patient
Scientific Title
Prediction of neurological prognosis by automated quantitative pupillometry in post resuscitation patients
Scientific Title:Acronym
Pupil reaction in postresuscitation patient
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
To evaluate prospectively whether the pupillary objective evaluation is useful for prediction of neurological prognosis in the patients after resuscitation from out-of-hospital cardiac arrest
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The survival rate and consciousness recovery rate by the Glasgow-Pittsburg Outcome Categories on the 30th and 90th hospital day
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients after resuscitation from an out-of-hospital cardiac arrest whose spontaneous circulation has returned in the emergency room or before arrival to the hospital
Key exclusion criteria
1.Trauma, aortic dissection, or terminal stage of cancer
2.Do Not Attempt Resuscitate (DNAR)
3.A pregnant woman
4.A cerebral function state before cardiac arrest is poor
5.Use of PCPS
6.Patients not applicable for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Sasaki |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
sasakij@1989.jukuin.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Shibusawa |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
takayukishibusawa@gmail.com
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Donation or research grant of non profit foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
慶應義塾大学病院（東京都）、済生会横浜市東部病院（神奈川県）、済生会中央病院（東京都）、川崎市立川崎病院（神奈川県）、済生会宇都宮病院（栃木県）、平塚市民病院（神奈川県）、日本医科大学附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 01 | 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
| 2014 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 22 | Day |
Other
Other related information
Study design: Single arm, uncontrolled, and prospective study
Measurements: Pupil examination by a pupillometer
Results: Survival rate and consciousness recovery rate
Management information
Registered date
| 2014 | Year | 11 | Month | 11 | Day |
Last modified on
| 2019 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018164
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2020/02/12 | UMIN000018164_data repository_2020-02-04.xlsx |
