UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029057 |
|---|---|
| Receipt number | 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 | 2024/09/15 16:55:56 |
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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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
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
| 1 | days-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 | Aki |
| Middle name | |
| Last name | Akinari |
Organization
Nagoya University Graduate School of Medicine
Division name
Pediaric surgery
Zip code
4668550
Address
65 Tsurumai, Showa, Nagoya
TEL
052-744-2959
hinoki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Kazuki |
Organization
Nagoya University Graduate School of Medicine
Division name
Pediaric surgery
Zip code
4668550
Address
65 Tsurumai, Showa, Nagoya
TEL
052-744-2959
Homepage URL
k-yokota@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
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
Nagoya University Hospital ethics committee
Address
Tsurumaicho65, Syowa-ku, nagoya, Aichi
Tel
+81527412111
ethics@med.nagoya-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
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
100
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because the paper has not been accepted.
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 19 | Day |
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
| 2022 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 09 | Month | 08 | Day |
Last modified on
| 2024 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033232
