UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000011493
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Last 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
Email kmori@marianna-u.ac.jp

Public contact
1st 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
Email kmori@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Department of Emergency and Critical Care Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013446


Contact us.