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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000026824
Receipt No. R000020412
Scientific Title Association between perioperative white blood cell function and postoperative outcome including lung injury
Date of disclosure of the study information 2017/04/02
Last modified on 2018/04/02

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Basic information
Public title Association between perioperative white blood cell function and postoperative outcome including lung injury
Acronym Perioperative white blood cell function and postoperative outcome
Scientific Title Association between perioperative white blood cell function and postoperative outcome including lung injury
Scientific Title:Acronym Perioperative white blood cell function and postoperative outcome
Region
Japan

Condition
Condition surgery for esophageal cancer, lower and upper extremity orthopedic surgery, spine surgery, peripheral vascular surgery, gastrectomy, abdominal aortic aneurysm, lung resection, and non-smoking healthy volunteer
Classification by specialty
Surgery in general Gastrointestinal surgery Vascular surgery
Chest surgery Orthopedics Anesthesiology
Neurosurgery Cardiovascular surgery Emergency medicine
Intensive care medicine Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Determine the occurrence of postoperative respiratory complications, and identify background and clinical factors that affect outcome
Basic objectives2 Others
Basic objectives -Others Assess the relationship between leukocyte function, serum inflammatory mediators and occurrence of postoperative respiratory complications, and identify background and clinical factors affecting above parameters.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Occurrence of postoperative acute lung injury during hospital stay
Key secondary outcomes Postoperative hypoxia, occurrence of postoperative other pulmonary complications. Postoperative ICU stay, duration of ventilation dependent period, postoperative hospital stay, postoperative mortality

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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients who give consent to phlebotomy.
Key exclusion criteria Patients who underwent chemotherapy or radiation within 4 weeks before surgery. Patients who received direct surgical insult to the lung, with massive pulmonary hemorrhage. Patients with transfusion related acute lung injury. Patients with preoperative anemia (Blood hemoglobin <7.0g/dL). Patients who are considered not to be clinically eligible for blood draw.
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kanji Uchida
Organization The University of Tokyo Hospital
Division name Department of Anesthesiology and Pain Relief Center
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email uchidak-ane@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kanji Uchida
Organization The University of Tokyo Hospital
Division name Department of Anesthesiology and Pain Relief Center
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email uchidak-ane@h.u-tokyo.ac.jp

Sponsor
Institute The University of Tokyo
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 02 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 Enrolling by invitation
Date of protocol fixation
2006 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood pressure, pulse, arterial blood oxygen saturation, respiratory rate, body temperature, chest radiograph findings, CT image findings, medical record on medical conditions, blood count, blood biochemistry, blood gas data are extracted from the electronic medical record. 10 ml heparinized blood is collected from the artery or vein before and after operation, postoperative day1, day5, day7 and day10. Actual experience other than blood sampling is the same as usual intraoperative and postoperative experience. Regarding psychological distress, if there is a catheter inserted directly into the artery for perioperative treatment, blood sampling from the catheter is performed, so there is no pain. When the arterial catheter is not inserted, blood is collected at the same time when blood collection is done for therapeutic treatment, and the pain accompanying the puncture is minimized. If there is psychological resistance to the amount of blood collection, consult with the subject and consider reducing blood collection volume for research to about 5 cc. Regarding the physical burden, such as anemia cases with an Hb value less than 7 g / dl, when it is judged clinically that the state of the subject does not tolerate blood collection, blood collection for research is suspended.

Management information
Registered date
2017 Year 04 Month 01 Day
Last modified on
2018 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020412

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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