UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027264 |
|---|---|
| Receipt number | R000029591 |
| Scientific Title | Prediction of fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position. |
| Date of disclosure of the study information | 2017/05/10 |
| Last modified on | 2018/03/02 18:13:18 |
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Basic information
Public title
Prediction of fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Acronym
Fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Scientific Title
Prediction of fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Scientific Title:Acronym
Fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether dynamic parameters such as pulse pressure variation and stroke volume variation could predict fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position, especially in thoracoscopic procedure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ROC and AUC of PPV, SVV, PPV/SVV ratio, Heart rate, MAP and CVP to fluid responsiveness.
Key secondary outcomes
The changes in PPV, SVV, PPV/SVV ratio, CI, heart rate, MAP and CVP before and after the fluid bolus.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Implementation period:day (during surgery)
Machine:Edwards Lifesciences
EV1000 and FloTrac sensor
When mean blood pressure decrease to 65 mmHg or less during thoracoscopic procedure with prone position, we have to inject 200ml of Hydroxyethyl Starch in sodium chloride injection (Voluven) will be administered over 10 minutes.
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
1)Patients with esophageal cancer undergoing thoracoscopic esophagectomy with prone position.
2)Patient who are 20 years or older.
3)Patients with ASA physical status of 3 or less.
4)Patients capable of giving written informed consent for the participation in this study.
Key exclusion criteria
1)Patients who are unable to have an operation with thoracoscopic approach.
2)Patients who cannot take prone position.
3)Patients who preoperatively have
cardiac arrhythmia.
4)history of myocardial ischemia.
5)unstable angina pectoris.
6)history of pulmonary edema or congestive heart failure.
7)severe liver dysfunction (AST or ALT of 100 IU/L or greater).
8)severe renal dysfunction (Creatinine of 3 mg/dl or greater, or undergoing dialysis).
9)intracranial hemorrhage.
10)severe hypernatremia or severe hyperchloremia.
11)Pregnant women or women of childbearing potential.
12)Lactating women.
13)Inability to fully comprehend and/or perform study procedures in the investigator opinion.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morimatsu |
Organization
Okayama University Graduate School of Medicine, Dentistry and
Pharmaceutical Science
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
2-5-1 Kita-ku,Shikata-cho, Okayama
TEL
086-235-7778
morima-h@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukiko Hikasa |
Organization
Okayama University Hospital
Division name
Department of intensive Care
Zip code
Address
2-5-1 Kita-ku,Shikata-cho, Okayama
TEL
086-235-7778
Homepage URL
ichi_go_ichi_e_kokoro@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Edwards Lifescience
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 05 | Month | 10 | 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 08 | Day |
Last modified on
| 2018 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029591
