UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021881 |
|---|---|
| Receipt number | R000025230 |
| Scientific Title | The effects of hydroxyethyl starch loading on perioperative fluid balance |
| Date of disclosure of the study information | 2016/04/12 |
| Last modified on | 2018/02/13 21:58:41 |
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Basic information
Public title
The effects of hydroxyethyl starch loading on perioperative fluid balance
Acronym
The effects of hydroxyethyl starch loading on perioperative fluid balance
Scientific Title
The effects of hydroxyethyl starch loading on perioperative fluid balance
Scientific Title:Acronym
The effects of hydroxyethyl starch loading on perioperative fluid balance
Region
| Japan |
Condition
Condition
Relative hypovolemia on anesthesia induction
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to study the effects of hydroxyehyl starch loading for relative hypovolemia caused by anesthesia induction on perioperative fluid balance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Perioperative fluid balance (infusion, transfusion, urine output, blood loss).
Key secondary outcomes
Dose of vasopressors.
Count of blood cells (WBC, RBC, Hb, Platelets), Biochemical test (Alb, AST, ALT, LDH, BUN,Cr, CRP, electrolytes) on 0, 1 and 7 postoperative day.
Postoperative ICU stay days
Postoperative in-hospital days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hydroxyethyl starch loading
Interventions/Control_2
Acetate Ringer's solution loading
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases scheduled for elective laparoscopic gastrointestinal malignancy surgery and postoperative ICU admission
Key exclusion criteria
History of hydroxyethyl starch allergy, congestive heart failure, renal insufficiency, coagulation abnormality or thrombocytopenia.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Katoh |
Organization
Hyogo Cancer Center
Division name
Department of Anesthesia
Zip code
Address
13-70 Kitaoji Akashi
TEL
0789291151
whoami@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Katoh |
Organization
Hyogo Cancer Center
Division name
Department of Anesthesia
Zip code
Address
13-70 Kitaoji Akashi
TEL
0789291151
Homepage URL
whoami@hp.pref.hyogo.jp
Sponsor or person
Institute
Department of Anesthesia
Hyogo Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Deartment of Anesthesia
Hyogo Cancer Center
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
兵庫県立がんセンター(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 22 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 12 | Day |
Last modified on
| 2018 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025230
