UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026824 |
|---|---|
| Receipt number | 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 18:34:20 |
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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
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
uchidak-ane@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020412
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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