UMIN-CTR Clinical Trial

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
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Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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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
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Other related organizations
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IRB Contact (For public release)
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Address
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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
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Results
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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/icdr_e/ctr_view.cgi?recptno=R000023269