UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020146 |
|---|---|
| Receipt number | 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 11:06:05 |
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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
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
shirohisono@yahoo.co.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023269
