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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000005558
Receipt No. R000006575
Scientific Title Effects on gas exchange of the extracorporeal membrane oxygenation in severe respiratory failure
Date of disclosure of the study information 2011/05/06
Last modified on 2020/05/12

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Basic information
Public title Effects on gas exchange of the extracorporeal membrane oxygenation in severe respiratory failure
Acronym Effects on gas exchange of the extracorporeal membrane oxygenation in severe respiratory failure
Scientific Title Effects on gas exchange of the extracorporeal membrane oxygenation in severe respiratory failure
Scientific Title:Acronym Effects on gas exchange of the extracorporeal membrane oxygenation in severe respiratory failure
Region
Japan

Condition
Condition severe respiratory failure
Classification by specialty
Pneumology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of combined therapy with traditional ventilatory support using low tidal volume and extracorporeal membrane oxygenation (ECMO) in patients with severe respiratory failure, for minimizing the use of anticoagulants and mechanical damage on blood cells, and for avoiding the ventilator-induced lung injury
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in partial pressure of carbon dioxide and partial pressure of oxygen
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 ECMO-treated group. The combination therapy of ECMO and the conventional low tidal volume ventilation is introduced. Two venous cannulae are inserted in the jugular vein (for blood removal) and the femoral vein (for blood return) under the echo ultrasound-guidance. ACT is maintained around 150 seconds by heparin or nafamostat mesilate. The blood flow is controlled within 5-20 mL/min/kg (maximum 1000 mL/min), and the oxygen flow is adjusted within 3-5 L/min. When the discontinuation criteria are met, the treatment with ECMO is aborted. In this group, the concurrent ventilatory mode is limited to the conventional low tidal volume ventilation of less than 6 mL/kg.
Interventions/Control_2 Non-ECMO-treated group. The conventional low tidal volume ventilation alone is started. The ventilatory strategy is consisted of low tidal volume ventilation and open lung strategy recommended by ARDS Network.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria (1)Patients with severe acute respiratory failure under mechanical ventilation (hypoxia of PaO2/FIO2 ratio <200mmHg, or hypercapnia of PaCO2 >=60mmHg)
(2)Documented informed consent can be obtained from the patient or his/her family for his/her participation in the study
Key exclusion criteria (1)Patients with life-threatening respiratory failure
(2)Patients with contraindications to anticoagulant drugs
(3)Pregnant woman
(4)Patients who are considered inappropriate for enrollement in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Nobuaki
Middle name
Last name Shime
Organization Hiroshima University
Division name Department of Emergency and Critical Care Medicine
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5456
Email nshime@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Shinichiro
Middle name
Last name Ohshimo
Organization Hiroshima University
Division name Department of Emergency and Critical Care Medicine
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima 734-8551, Japan
TEL 082-257-5456
Homepage URL
Email ohshimos@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Medical Policy Office, Hiroshima University
Address 1-2-3, Kasumi, Minami-kku, Hiroshima, 734-8551
Tel 082-257-5907
Email iryo-seisaku@office.hiroshima-u.ac.jp

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
2011 Year 05 Month 06 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 Enrolling by invitation
Date of protocol fixation
2011 Year 05 Month 06 Day
Date of IRB
2011 Year 03 Month 09 Day
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
2031 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 05 Month 06 Day
Last modified on
2020 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006575

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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