UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017964 |
|---|---|
| Receipt number | R000020819 |
| Scientific Title | Comparison between colloid solutions on the hemodynamics in patients undergoing major gastrointestinal surgery. |
| Date of disclosure of the study information | 2015/07/01 |
| Last modified on | 2021/06/22 10:28:45 |
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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
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
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
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
Toho University Ohashi Medical Center
Address
2-17-6, Ohashi, Meguro, Tokyo
Tel
03-3468-1251
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020819
