UMIN-CTR Clinical Trial

Basic information
Public title	Comparison between colloid solutions on the hemodynamics in patients undergoing major gastrointestinal surgery.
Acronym	Hemodynamic effects of intraoperative colloids
Scientific Title	Comparison between colloid solutions on the hemodynamics in patients undergoing major gastrointestinal surgery.
Scientific Title:Acronym	Hemodynamic effects of intraoperative colloids
Region	Japan

Condition
Condition	Elective hepatobiliary surgery
Classification by specialty	Gastrointestinal surgery Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparison between albumin and hydroxyethyl starch solution
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Time course of stroke volume measured with invasive and non-invasive pulse contour analysis. Change of respiratory variation of stroke volume, pulse pressure and plethysmographic waveform Change of left ventricular volume Change of colloid osmotic pressure and hemodilution
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients whose surgical team request intraoperative administration of 5% albumin
Key exclusion criteria	Patients who had known conditions that may negatively affect the accuracy of stroke volume measurement with pulse contour method. Patients who have any contraindication of transesophageal echocardiographic examination.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshifumi Middle name Last name Kotake
Organization	Toho University Ohashi Medical Center
Division name	Department of Anesthesiology
Zip code	158-8515
Address	2-17-6, Ohashi, Meguro, Tokyo
TEL	03-3468-1251
Email	ykotake@med.toho-u.ac.jp

Public contact
Name of contact person	1st name Yoshifumi Middle name Last name Kotake
Organization	Toho University Ohashi Medical Center
Division name	Department of Anesthesiology
Zip code	158-8515
Address	2-17-6, Ohashi, Meguro, Tokyo
TEL	03-3468-1251
Homepage URL
Email	ykotake@med.toho-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Toho University Ohashi Medical Center
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	Toho University Ohashi Medical Center
Address	2-17-6, Ohashi, Meguro, Tokyo
Tel	03-3468-1251
Email	secretary@oha.toho-u.ac.jp

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	東邦大学医療センター大橋病院（東京都） Toho University Ohashi Medical Center (Tokyo)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 01 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	2015 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	In this study, the change of colloid osmotic pressure and degree of hemodilution caused by albumin, synthetic colloid and crystalloid are measured in order to evaluate the difference of volume effects of these solutions in clinical situation.

Management information
Registered date	2015 Year 06 Month 18 Day
Last modified on	2021 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020819