UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030734 |
|---|---|
| Receipt number | 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 | 2019/09/21 14:45:30 |
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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 | Yasuyuki |
| Middle name | |
| Last name | Seto |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Gastrointestinal Surgery
Zip code
113-8655,
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shuichiro |
| Middle name | |
| Last name | Oya |
Organization
Graduate School of Medicine, University of Tokyo
Division name
Gastrointestinal Surgery
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Homepage URL
OYAS-SUR@h.u-tokyo.ac.jp
Sponsor or person
Institute
University of Tokyo
Institute
Department
Personal name
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
Ethical comittee of the University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
Tel
03-5841-3557
ethics@m.u-tokyo.ac.jp
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
| 2017 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
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
| 2019 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030578
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| Registered date | File name |
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| Registered date | File name |
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