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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029057
Receipt No. R000033232
Scientific Title A prospective randomized controlled trial of isotonic versus hypotonic maintenance intraveneous fluids after surgery for children
Date of disclosure of the study information 2017/11/01
Last modified on 2018/03/12

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Basic information
Public title A prospective randomized controlled trial of isotonic versus hypotonic maintenance intraveneous fluids after surgery for children
Acronym A prospective randomized controlled trial of isotonic versus hypotonic maintenance intraveneous fluids after surgery for children
Scientific Title A prospective randomized controlled trial of isotonic versus hypotonic maintenance intraveneous fluids after surgery for children
Scientific Title:Acronym A prospective randomized controlled trial of isotonic versus hypotonic maintenance intraveneous fluids after surgery for children
Region
Japan

Condition
Condition Pediatric patient who will be performed abdominal surgery.
Classification by specialty
Surgery in general Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 After surgery in pediatric patients, it is said that the invasive stress tends to become SIADH and cause hyponatremia. Consider appropriate composition in postoperative maintenance intraveneous fluids of pediatric patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood sampling are performed on the 3rd postoperative day. Primary outcome is serum Na, 136 mEq / L or less is defined as hyponatremia and its frequency is compared.
Key secondary outcomes Secondary endpoints were examination of changes in serum Na levels before and after surgery and analyzed ADH, plasma osmotic pressure, urinary osmotic pressure and urinary Na, respectively, and compared with SIADH and also consider the relationship.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Extracellular fluid is used as a postoperative maintenance intraveneous fluidsuntil 3 days after operation.
Interventions/Control_2 Half saline is used as a postoperative maintenance intraveneous fluidsuntil 3 days after operation.
Interventions/Control_3 About 0.23% saline is used as a postoperative maintenance intraveneous fluidsuntil 3 days after operation.
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
0 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria Patients who are undergoing surgery in our department and are expected to have meals on or after the 3rd postoperative day.
Key exclusion criteria Patients suffering from heart disease, renal disease, central nervous disease, patients taking diuretics, neonates.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinari Hinoki
Organization Nagoya University Graduate School of Medicine
Division name Pediaric surgery
Zip code
Address 65 Tsurumai, Showa, Nagoya
TEL 052-744-2959
Email hinoki@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Yokota
Organization Nagoya University Graduate School of Medicine
Division name Pediaric surgery
Zip code
Address 65 Tsurumai, Showa, Nagoya
TEL 052-744-2959
Homepage URL
Email k-yokota@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 11 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
2017 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 06 Month 30 Day
Date trial data considered complete
2021 Year 09 Month 30 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 08 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033232

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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