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

Email

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

Email

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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013446


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name