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


Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name