UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036240
Receipt number 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 2022/09/22 12:34:27

* 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 or person

Institute

Shonan Kamakura General Hospital
Department of Anesthesia

Institute

Department

Personal name



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

Value
https://center6.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