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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032769
Receipt No. R000036948
Scientific Title Effect of low dose of noradrenaline on the hypotension in the patients with general surgery: Case controlled study
Date of disclosure of the study information 2018/06/03
Last modified on 2018/05/30

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Basic information
Public title Effect of low dose of noradrenaline on the hypotension in the patients with general surgery: Case controlled study
Acronym Effect of low dose of noradrenaline on the hypotension in the patients with general surgery
Scientific Title Effect of low dose of noradrenaline on the hypotension in the patients with general surgery: Case controlled study
Scientific Title:Acronym Effect of low dose of noradrenaline on the hypotension in the patients with general surgery
Region
Japan

Condition
Condition surgical patients
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is that investigate of the effect of low dose of noradrenaline on the hypotension in the patients with general surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To compare the effect to raise blood pressure via low doses of noradrareline and dopamine and to examine the usefulness of noradrenaline
Key secondary outcomes Prove the safety of noradrenaline use at low dose in surgical patients

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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1.patients over 20years old
2.It does not matter men and women
3.Patient agreed with this protocol
Key exclusion criteria 1. Patients with Pheochromocytoma
2. Shock aptients
3. Patients with Dialysis
4. Pregnat woman
5. Energency operation
6. Obviously death patient
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Isao Tsuneyoshi
Organization Faculty of medicine University of Miyazaki
Division name Department of Anesthesiology
Zip code
Address 5200 Kihara Kiyotake Miyazaki
TEL 0985-85-9357
Email isao45@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isao Tsuneyoshi
Organization Faculty of medicine University of Miyazaki
Division name Department of Anesthesiology
Zip code
Address 5200 Kihara Kiyotake Miyazaki
TEL 0985-85-9357
Homepage URL http://www.med.miyazaki-u.ac.jp/home/masui/
Email isao45@med.miyazaki-u.ac.jp

Sponsor
Institute Department of Anesthesiology Faculty of medicine University of Miyazaki
Institute
Department

Funding Source
Organization Clinical research support expenses in 2018
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
2018 Year 06 Month 03 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 04 Month 10 Day
Date analysis concluded
2020 Year 04 Month 29 Day

Other
Other related information Observational study

Management information
Registered date
2018 Year 05 Month 30 Day
Last modified on
2018 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036948

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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