UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036240
Receipt No. R000040726
Scientific Title Monitoring of stroke volume variation and fluid responsiveness in laparotomy and pneumoperitoneum surgery
Date of disclosure of the study information 2019/03/18
Last modified on 2019/03/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Open public recruiting
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
2022 Year 06 Month 30 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
2019 Year 03 Month 18 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.