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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030734
Receipt No. R000030578
Scientific Title Assesment of the body water distribution after esophagectomy using Bioelectrical Impedance Analysis(BIA) device and FloTrac system
Date of disclosure of the study information 2018/01/09
Last modified on 2018/01/09

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Basic information
Public title Assesment of the body water distribution after esophagectomy using Bioelectrical Impedance Analysis(BIA) device and FloTrac system
Acronym Assesment of the body water distribution after esophagectomy using BIA device and FloTrac system
Scientific Title Assesment of the body water distribution after esophagectomy using Bioelectrical Impedance Analysis(BIA) device and FloTrac system
Scientific Title:Acronym Assesment of the body water distribution after esophagectomy using BIA device and FloTrac system
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 During the perioperative phase of esophagectomies, cardiovascular or respiratory adverse events occur to some extent due to the changes in the distribution of body water, which makes the positoperative fluid management more important. The aim of this study is to evaluate the utilities of a Bioelectrical Impedance (BIA) device and the FloTrac system for estimating the body water distribution and the circulatory dynamics after esophageal surgeries.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison between the estimated dates of the fluid retention by the traditional judging methods(negative water balance in record-based calculation, decrease in body weight) and the date estimated by the peak in each maker of Bioelectrical Impedance Analysis(BIA) measured on admission day and from postoperative 0 to 7days, or of FloTrac systems measured postoperatively.
Key secondary outcomes 1) Correlation between the marker trends in BIA or FloTrac system and the trends in blood markers(Hb,Hct,Alb,BUN/Cre,CRP)or urinary osmolarity.
2) Correlation between the postoperative courses (adverse events, length of ICU stay, length of hospital stay) and the levels of BIA or FloTrac markers at postoperative specific timing.
3) Difference in BIA or FloTrac marker peaks among different esophageal surgical procedures.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 1) Preoperative BIA measurement after admission(~5 minutes).
2) Anaestheologists insert the peripheral arterial catheter during the esophagectomy and connect to the FloTrac system (intraoperative procedure).
3) BIA measurement at 1 hour after the surgery(~5min). FloTrac markers at the same time are also recorded (automatically).
4) From postoperative day 1 to 7, BIA measurements are perfomed at i)every 10:00 and 18:00(twice/day) or ii) every 12:00(once/day). Will take ~5 minutes each time.
5) From postoperative day 1, FloTrac markers are monitored continuously until the patients discharged from ICU. Each markers are recorded prospectively at every 02:00,10:00,18:00.
6) Urinary samples are submitted to check the osmolarity and the blood sugar from postoperative day 1 to 7 (~5 minutues each time).
7) Postoperative blood samplings, vital signs measurements, calculations of the body water balance are also performed only within routine postoperative managements (not specific for the present study).
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meets all of the conditions below are included in the study.
1) Who are to receive esophagectomy for esophageal cancer at University of Tokyo Hospital.
2) Agreed to participate in the study in documents.
Key exclusion criteria Patients who meets any of the conditions below are excluded from the study.
1) Those under 20 years old.
2) Those with heart pacemakers.
3) Those with preoperatively diagnosed heart failure or respiratory failure.
4) Those who cannnot use electrodes for BIA devices due to allergic reactions or dermatological problems.
5) Those who cannot keep the supine position during the measurements due to psychological or other factors.
6) Those who meet the contraindication criteria described in the manuals of BIA device (MLT-550N) or FloTrac system.
7) Those who have ineligibility judged by the researchers of the study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Seto
Organization Graduate School of Medicine, University of Tokyo
Division name Gastrointestinal Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Email seto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuichiro Oya
Organization Graduate School of Medicine, University of Tokyo
Division name Gastrointestinal Surgery
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-3815-5411
Homepage URL
Email OYAS-SUR@h.u-tokyo.ac.jp

Sponsor
Institute University of Tokyo
Institute
Department

Funding Source
Organization Department of Gastrointestinal Surgery, Graduate School of Medicine, University of Tokyo
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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 09 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
2017 Year 04 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 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
2018 Year 01 Month 09 Day
Last modified on
2018 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030578

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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