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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020146
Receipt No. R000023269
Scientific Title Postoperative ambulatory blood pressure monitoring and cardiac function in patients with sleep disordered breathing
Date of disclosure of the study information 2015/12/10
Last modified on 2019/12/13

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Basic information
Public title Postoperative ambulatory blood pressure monitoring and cardiac function in patients with sleep disordered breathing
Acronym Sleep disordered breathing and postoperative cardiac functions
Scientific Title Postoperative ambulatory blood pressure monitoring and cardiac function in patients with sleep disordered breathing
Scientific Title:Acronym Sleep disordered breathing and postoperative cardiac functions
Region
Japan

Condition
Condition Adult patients undergoing abdominal surgeries under general anesthesia combined with epidural anesthesia
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore whether patterns of preoperative nocturnal blood pressure monitoring are associated with level of serum high-sensitive troponin T after abdominal surgeries in patients with sleep disordered breathing.
Basic objectives2 Others
Basic objectives -Others effectiveness of preoperative evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of serum high-sensitive troponin T
Key secondary outcomes patterns of nocturnal blood pressure changes, sleep disordered breathing, NT-proBNP

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Patients undergoing abdominal surgeries
2. Patients scheduled for general anesthesia combined with epidural anesthesia
3. Patients with hypertension (systolic and diastolic blood pressure greater and/or equal to 140mmHg and 90mmHg, respectively, or under treatment)
4. Patients with moderate to sever sleep disordered breathing
Key exclusion criteria 1. Shift worker
2. Obstructive sleep apnea patients treated with nasal CPAP more than one month
3. Patients with severe cardiac diseases
4. Patients with intra-cranial pathologies
5. Patients with hypoxemia
6. Patients with tracheostomy
7. Patients without indication for extubation in the operating room
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiroh Isono
Organization Graduate School of Medicine, Chiba University
Division name Anesthesiology
Zip code
Address 1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL 043-222-7171
Email shirohisono@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiroh Isono
Organization Graduate School of Medicine, Chiba University
Division name Anesthesiology
Zip code
Address 1-8-1 Inohana-cho, Chuo-ku, Chiba
TEL 043-222-7171
Homepage URL
Email shirohisono@yahoo.co.jp

Sponsor
Institute Graduate School of Medicine, Chiba University
Institute
Department

Funding Source
Organization Japanese grant-in-aid for challenging explaratory resarch (26670679) from the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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 千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2015 Year 12 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
2015 Year 11 Month 09 Day
Date of IRB
2015 Year 11 Month 09 Day
Anticipated trial start date
2015 Year 12 Month 10 Day
Last follow-up date
2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a prospective observational (Cohort) study exploring whether preoperative nocturnal blood pressure patterns are associated with changes of cardiac functions assessed by bio-markers such as high-sensitive troponin T and NT-proBNP after abdominal surgeries under general anesthesia combined epidual anesthesia in patients with moderate to severe sleep disordered breathing and with hypertension (systolic and diastolic blood pressure greater and/or equal to 140mmHg and 90mmHg, respectively, or under treatment). Types of nocturnal blood pressure changes (dipper and non-dipper types) are determined by an investigator who do not know the values of the troponin T and other cardiac markers.

Management information
Registered date
2015 Year 12 Month 10 Day
Last modified on
2019 Year 12 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023269

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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