UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010674
Receipt No. 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

* 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 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
Email

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
Email

Sponsor
Institute Department of Anesthesiology, Tokyo Medical and Dental University, Graduate School of Medicine
Institute
Department

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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012420

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.