UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010674 |
|---|---|
| Receipt number | R000012420 |
| Scientific Title | Clinical evaluation of receptor for advanced glycation endproducts (RAGE) as a biomarker for lung injury |
| Date of disclosure of the study information | 2013/05/10 |
| Last modified on | 2013/05/08 20:03:59 |
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Basic information
Public title
Clinical evaluation of receptor for advanced glycation endproducts (RAGE) as a biomarker for lung injury
Acronym
RAGE as a biomarker for lung injury
Scientific Title
Clinical evaluation of receptor for advanced glycation endproducts (RAGE) as a biomarker for lung injury
Scientific Title:Acronym
RAGE as a biomarker for lung injury
Region
| Japan |
Condition
Condition
Patients undergoing cardiac surgery
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measure the RAGE levels perioperatively, and study the relationship betweem RAGE levels and duration of mechanical ventilation.
Basic objectives2
Others
Basic objectives -Others
We study the predictive performance of biomarkers to detect postoperative respiratory dysfunction.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between RAGE levels and duration of mechanical ventilation
Key secondary outcomes
Relationships between RAGE and other biomarker proteins (interleukin-8, S100/A12, Angiopoietins, von Willbrand factor antigen, HMGB1 etc)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective cardiac surgery listed below
(1) Aortic surgery
(2) Valve surgery
(3) Offpump coronary artery bypass grafting
Key exclusion criteria
Preoperative exclusion criteria were: 1) patient's age < 20 years; 2) history of myocardial infarction within 30 days before the day of surgery; 3) preoperative diagnosis of pneumothorax; 4) diagnosis of chronic obstructive pulmonary disease; 5) neuromuscular disease; 6) morbidly obese (body mass index > 40); and 7) systemic connective tissue disease. Postoperative exclusion criteria were: 1) severe neurological complications requiring mechanical ventilation; 2) the need for an extracorporeal circuit due to cardiac failure; and 3) patients whose pulmonary artery occlusion pressure (PAOP) was >18 mm Hg in the first postoperative week.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tokujiro Uchida |
Organization
Tokyo Medical and Dental University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
81-3-5803-5325
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokujiro Uchida |
Organization
Tokyo Medical and Dental University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The University of Tokyo Hospital
Yokohama City University Medical Center
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
東京医科歯科大学医学部附属病院(東京都)
東京大学医学部附属病院 (東京都)
横浜市立市民医療センター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 10 | 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
| 2007 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2009 | Year | 08 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Eighty-seven patients undergoing elective cardiac surgery were enrolled in this multicenter observational study.
Management information
Registered date
| 2013 | Year | 05 | Month | 08 | Day |
Last modified on
| 2013 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012420
