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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018632
Receipt No. R000021563
Scientific Title Relationships between orthostatic hypotension and cardiovascular responses to early postoperative mobilization in patients undergoing cardiothoracic and abdominal surgery
Date of disclosure of the study information 2015/08/10
Last modified on 2015/08/13

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Basic information
Public title Relationships between orthostatic hypotension and cardiovascular responses to early postoperative mobilization in patients undergoing cardiothoracic and abdominal surgery
Acronym Cardiovascular responses for early postoperative mobilization in patients undergoing surgery
Scientific Title Relationships between orthostatic hypotension and cardiovascular responses to early postoperative mobilization in patients undergoing cardiothoracic and abdominal surgery
Scientific Title:Acronym Cardiovascular responses for early postoperative mobilization in patients undergoing surgery
Region
Japan

Condition
Condition Postoperative patients undergoing cardiothoracic and abdominal surgery
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Chest surgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The primary aim of this study is to determine the incidence of OH and its clarified relationship to cardiovascular changes and symptoms after each major surgery.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of OH
Key secondary outcomes Relationship to cardiovascular changes and symptoms

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria were planned surgery and written informed consent.
Key exclusion criteria Exclusion criteria were comorbid conditions affecting exercise performance (e.g. musculoskeletal or neurological impairment) and re-operation, serious organ dysfunction.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masatoshi Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Email mstshnd@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masatoshi Hanada
Organization Nagasaki University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7258
Homepage URL
Email mstshnd@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results The present study found a high incidence (38 %) of OH during early mobilization in all patients underwent cardiothoracic and abdominal surgery.
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
2008 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2012 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design
prospective observational study

Inclusion criteria
We enrolled in patients underwent cardiac surgery group and thoracic surgery group, abdominal surgery group.

Statistical analyses
Variables of orthostatic hypotension, age, gender, body mass index, operative time and blood loss, drugs, BP and MAP, HR, SpO2, RR was changed throughout mobilization

Management information
Registered date
2015 Year 08 Month 10 Day
Last modified on
2015 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021563

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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