UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between perioperative white blood cell function and postoperative outcome including lung injury
Title of the study (Brief title)	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	Kanji Uchida
Organization	The University of Tokyo Hospital
Division name	Department of Anesthesiology and Pain Relief Center
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	Kanji Uchida
Organization	The University of Tokyo Hospital
Division name	Department of Anesthesiology and Pain Relief Center
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2006 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020412