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

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 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


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

Value
https://center6.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