UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006942 |
|---|---|
| Receipt number | R000008171 |
| Scientific Title | The effect of sodium concentration in the maintenance intravenous fluid therapy on iatrogenic hyponatremia of children with acute illness : a randomized controlled trial |
| Date of disclosure of the study information | 2011/12/28 |
| Last modified on | 2011/12/24 14:37:24 |
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Basic information
Public title
The effect of sodium concentration in the maintenance intravenous fluid therapy on iatrogenic hyponatremia of children with acute illness : a randomized controlled trial
Acronym
NaMIH
Scientific Title
The effect of sodium concentration in the maintenance intravenous fluid therapy on iatrogenic hyponatremia of children with acute illness : a randomized controlled trial
Scientific Title:Acronym
NaMIH
Region
| Japan |
Condition
Condition
acute illness in children
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We make a comparison between traditional hyponatremic fluids(Na 35 mEq/l) and the relatively hypertonic fluids(Na 68 mEq/l) in the maintenance fluid therapy for pediatric patient with acute illness. We also assess the risk factor for hyponatremia and aim to prevent iatrogenic hyponatremia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of hyponatremia after maintenance intravenous fluid therapy
Key secondary outcomes
(1) Severiy of hyponatremia, clinical presentation associated with hyponatremia, with or without any other complication
(2) Change of serum sodium value between before and after maintenance intravenous fluid therapy
(3) Patient background-specific difference of incidence of hyponatremia
(4) Discontinuation rate of maintenance intravenous fluid therapy due to side effect
(5) Safety profile
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A : Hypotonic fluids(Na 35mEq/l) determined by the volumetirc Holliday-Segar formula.
Interventions/Control_2
Group B : Relatively hypertonic fluids(Na 68mEq/l : adding 10ml of 10% saline to 500ml of Group A's fluids ) at 80% of the Group A's rate.
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
| 3 | months-old | <= |
Age-upper limit
| 120 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients hospitalized with acute illness
2. Judged by the treating physician to require i.v. maintenance fluid administration for at least the following 24 h
3. A necessary clinical examination for dehydraion is confirmed before starting initial rehydraion therapy
4. Patient during or before initial rehydration therapy using normal saline or Ringer's solution(10-20ml/kg)
5. Age over 3months and under 10 years
6. Judged by the treating physician to have adequate liver/renal/cardiac function
7. Written informed concent must be obtained for the study from the parent or guardian
Key exclusion criteria
1. Patients with serum Na <130 or >150, serum K <3.2 or >5.5
2. Patients with clinical condition lilely to develop electrolyte abnormality
3. Treatment which affect the serum sodium value is planned
4. Patients who require drugs insoluble in allocated fluids during the study period
5. Any other cases who are regarded as inadequate for study enrollment by the investigator
Target sample size
2560
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junya Shimizu |
Organization
National Hospital Organization Okayama Medical Center
Division name
Department of Pediatrics
Zip code
Address
1711-1 Tamasu, Kita-ku, Okayama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junya Shimizu |
Organization
National Hospital Organization Okayama Medical Center
Division name
Department of Pediatrics
Zip code
Address
1711-1 Tamasu, Kita-ku, Okayama
TEL
086-294-9911
Homepage URL
junshimi@okayama3.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Okayama Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
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
弘前病院（青森県）、下志津病院（千葉県）、埼玉病院（埼玉県）、横浜医療センター（神奈川県）、相模原病院（神奈川県）、名古屋医療センター（愛知県）、三重病院（三重県）、三重中央医療センター（三重県）、岡山医療センター（岡山県）、南岡山医療センター（岡山県）、小倉医療センター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 24 | Day |
Last modified on
| 2011 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008171
