UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prediction of fluid responsiveness in patients undergoing thoracoscopic esophagectomy with prone position.
Title of the study (Brief title)	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	Hiroshi Morimatsu
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science
Division name	Department of Anesthesiology and Resuscitology
Address	2-5-1 Kita-ku,Shikata-cho, Okayama
TEL	086-235-7778
Email	morima-h@md.okayama-u.ac.jp

Public contact
Name of contact person	Yukiko Hikasa
Organization	Okayama University Hospital
Division name	Department of intensive Care
Address	2-5-1 Kita-ku,Shikata-cho, Okayama
TEL	086-235-7778
Homepage URL
Email	ichi_go_ichi_e_kokoro@yahoo.co.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029591