UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the transpulmonary thermodilution technique for the fluid resuscitation in sepsis
Title of the study (Brief title)	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	Kenichiro Morisawa
Organization	St. Marianna University School of Medicine
Division name	Department of Emergency and Critical Care Medicine
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	Kenichiro Morisawa
Organization	St. Marianna University School of Medicine
Division name	Department of Emergency and Critical Care Medicine
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 26 Day
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

Related information
URL releasing protocol	http://www.marianna-u.ac.jp/eccm/office/14297/014296.html
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000013446