UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035943
Receipt No. R000014586
Scientific Title The evaluation of time course of gastric fluid volume after drinking clear fluids in fasting state
Date of disclosure of the study information 2019/02/20
Last modified on 2019/02/20

* 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 The evaluation of time course of gastric fluid volume after drinking clear fluids in fasting state
Acronym The evaluation of gastric fluid volume in fasting state
Scientific Title The evaluation of time course of gastric fluid volume after drinking clear fluids in fasting state
Scientific Title:Acronym The evaluation of gastric fluid volume in fasting state
Region
Japan

Condition
Condition patients for elective surgery
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The object is to clarify the regulating factors of gastric emptying flow rate of clear fluids in fasting state in healthy adult volunteers. Preoperative fasting is common procedures in patients for elective surgery. Actually it is revealed that gastric emptying flow rate of clear fluids differ from one to another. It depends on the contents of clear fluid. The goal is to serve safe and suitable clear fluids for the surgical patients by determining the regulating factors of gastric emptying flow rate of clear fluids.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Gastric fluid volume after fasting, immediately after drinking clear fluid, and 30 min after drinking clear fluid.
Key secondary outcomes gastric emptying flow rate

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 To drink 500 mL of normal saline
-> (3days for washing out)
-> To drink 500 mL of isovolume mixture of 5% glucose solution and normal saline
Interventions/Control_2 To drink 500 mL of isovolume mixture of 5% glucose solution and normal saline
-> (3days for washing out)
-> To drink 500 mL of normal saline
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
50 years-old >
Gender Male and Female
Key inclusion criteria (1) Healthy without gastroenterological disease
(2) Body weight is 40 kg and more. Body Mass Index is between 18 and 30 kg/m^2
(3) Obtained written informed consent
Key exclusion criteria (1) Inability to examine Magnetic Resonance Imaging
(2) When the researcher evaluates that the candidate is not suitable for this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Chol KIM
Organization Nippon Medical School
Division name Department of Anesthesiology
Zip code
Address 1-1-5, Sendagi, Bunkyo-ku, Tokyo
TEL 03-3822-2131
Email ckim@nms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chol KIM
Organization Nippon Medical School Chiba Hokusoh Hospital
Division name Department of Anesthesia
Zip code
Address 1715 Kamagari, Inzai, Chiba
TEL 0476-99-1111
Homepage URL
Email ckim@nms.ac.jp

Sponsor
Institute Nippon Medical School Chiba Hokusoh Hospital

Department of Anesthesiology
Institute
Department

Funding Source
Organization Nippon Medical School Chiba Hokusoh Hospital

Department of Anesthesiology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Clinical Imaging Center for Healthcare, Nippon Medical School
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 日本医科大学健診医療センター
(Clinical Imaging Center for Healthcare, Nippon Medical School)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 20 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 Enrolling by invitation
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014586

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.