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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021881
Receipt No. 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

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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
Email 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
Email whoami@hp.pref.hyogo.jp

Sponsor
Institute Department of Anesthesia
Hyogo Cancer Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025230

Research Plan
Registered date File name
2017/10/13 HES研究実施計画書_2.pages

Research case data specifications
Registered date File name

Research case data
Registered date File name


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