UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring of stroke volume variation and fluid responsiveness in laparotomy and pneumoperitoneum surgery
Acronym	Fluid responsiveness in laparotomy and pneumoperitoneum surgery
Scientific Title	Monitoring of stroke volume variation and fluid responsiveness in laparotomy and pneumoperitoneum surgery
Scientific Title:Acronym	Fluid responsiveness in laparotomy and pneumoperitoneum surgery
Region	Japan

Condition
Condition	Gastrointestinal surgery
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify whether deterioration of fluid responsiveness seen in laparoscopic surgery is caused by threshold setting of SVV or change in circulation dynamics due to pneumoperitoneum
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fluid responsiveness by administration of artificial colloid solution
Key secondary outcomes	Side effects associated with fluid therapy

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	When FloTrac SVV >10%, rapid fluid therapy (artificial colloid solution, Once 200ml)
Interventions/Control_2	When FloTrac SVV >15%, rapid fluid therapy (artificial colloid solution, Once 200ml)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Inpatients who undergo gastrointestinal surgery
Key exclusion criteria	1) Patients with a history of myocardial infarction within 30 days prior to surgery 2) Patients with a history of percutaneous coronary intervention or coronary artery bypass surgery 3) Patients with unstable angina 4) Patients with decreased left ventricular function (LVEF<=50%) 5) Patients with a history of cerebrovascular disorder (excluding asymptomatic lacunar infarction) 6) Patients with a history of hospitalization due to heart failure within 30 days before surgery 7) Patients with severe liver disease (AST (GOT) or ALT (GPT)>=100 U) 8) Patients with severe kidney disease (BUN>25 mg / dL or serum creatinine>=2.0 mg / dL) 9) Patients with sepsis 10) Borben contraindicated patients 11) Women who may be pregnant or may become pregnant 12) A lactating woman 13) Patients with arrhythmia 14) In addition, patients whose research managers judged inappropriate based on medical evidence as research subjects
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yasuhiro Middle name Last name Koide
Organization	Shonan Kamakura General Hospital
Division name	Operating Room Management Center
Zip code	247-8533
Address	1370-1 Okamoto Kamakura Kanagawa-pref, JAPAN
TEL	0467-46-1717
Email	hiro5454@jcom.home.ne.jp

Public contact
Name of contact person	1st name Misaki Middle name Last name Ichikawa
Organization	Shonan Kamakura General Hospital
Division name	Research Office
Zip code	247-8533
Address	1370-1 Okamoto Kamakura Kanagawa-pref, JAPAN
TEL	0467-47-1717
Homepage URL
Email	m_ichikawa4@shonankamakura.or.jp

Sponsor
Institute	Shonan Kamakura General Hospital Department of Anesthesia
Institute
Department

Funding Source
Organization	None
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	Tokushukai Group Joint Ethics Review Committee
Address	1-8-7, Koji-machi, Chiyoda-ku Tokyo 102-0083, Japan
Tel	03-3263-4801
Email	03-3263-4802

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	2019 Year 03 Month 18 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	Terminated
Date of protocol fixation	2019 Year 03 Month 07 Day
Date of IRB	2019 Year 03 Month 07 Day
Anticipated trial start date	2019 Year 03 Month 18 Day
Last follow-up date	2020 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 18 Day
Last modified on	2022 Year 09 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040726