UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005558 |
|---|---|
| Receipt number | 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 09:49:15 |
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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
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
ohshimos@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006575
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
