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

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 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


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

Value
https://center6.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