UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011493 |
|---|---|
| Receipt number | R000013446 |
| Scientific Title | Evaluation of the transpulmonary thermodilution technique for the fluid resuscitation in sepsis |
| Date of disclosure of the study information | 2013/08/15 |
| Last modified on | 2018/08/19 23:54:22 |
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Basic information
Public title
Evaluation of the transpulmonary thermodilution technique for the fluid resuscitation in sepsis
Acronym
TPTD study
Scientific Title
Evaluation of the transpulmonary thermodilution technique for the fluid resuscitation in sepsis
Scientific Title:Acronym
TPTD study
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the usefulness of the transpulmonary thermodilution method (TPTD) in the fluid management for sepsis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ventilator-free days at 28 days
Key secondary outcomes
Probability of survival during 28 days, length of ICU stay, water balance for three days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
the group (TPTD group) which performed fluid management by the transpulmonary thermodilution method
Interventions/Control_2
the group (CVP group) which performed fluid management by using central venous pressure
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
A. Sepsis: infection focus and two items or more of following SIRS items corresponds.
a. Temperature >38C or <36C
b. Heart rate > 90/min
c. Number of breathing >20/min or PaCO2<32 mmHg
d. Leukocyte >12000/mu l or <4000/micro l
B. expected to require mechanical ventilatory support in ICU for at least 48 hours
Key exclusion criteria
Below 18 years of age,Pregnant women,Burns,Drug intoxication,Severe acute pancreatitis,Intracranial vascular lesions,Coronary artery disease,24 hours or more have passed after meeting a selection criteria,TPTD measurement is difficult,under percutaneous-cardiopulmonary-support equipment (PCPS),Present of DNAR,Occurrence of arrhythmia,Physician's discretion
Target sample size
196
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Morisawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa-ken, Japan
TEL
044-977-8111
kmori@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Morisawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa-ken, Japan
TEL
044-977-8111
Homepage URL
http://www.marianna-u.ac.jp/eccm/office/14297/014296.html
kmori@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Department of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Department of Emergency and Critical Care Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
聖マリアンナ医科大学病院（神奈川県）、東京ベイ市川浦安医療センター（千葉県）、大阪市立総合医療センター（大阪府）、日本医科大学千葉北総病院（千葉県）、埼玉赤十字病院（埼玉県）、武蔵野赤十字病院（東京都）、香川大学医学部附属病院（香川県）、産業医科大学病院（福岡県）、嬉野医療センター（佐賀県）、近畿大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
http://www.marianna-u.ac.jp/eccm/office/14297/014296.html
Publication of results
Partially published
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
| 2013 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 15 | Day |
Last modified on
| 2018 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013446
