UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041048 |
|---|---|
| Receipt number | R000046875 |
| Scientific Title | Predicting effective and safe fluid removal by furosemide bolus administration in critically ill neonates and infants |
| Date of disclosure of the study information | 2020/07/09 |
| Last modified on | 2020/07/09 13:10:43 |
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Basic information
Public title
Predicting effective and safe fluid removal by furosemide bolus administration in critically ill neonates and infants
Acronym
Predicting effective and safe fluid removal by furosemide bolus administration in critically ill neonates and infants
Scientific Title
Predicting effective and safe fluid removal by furosemide bolus administration in critically ill neonates and infants
Scientific Title:Acronym
Predicting effective and safe fluid removal by furosemide bolus administration in critically ill neonates and infants
Region
| Japan |
Condition
Condition
Non-cardiac critically ill neonates and infants
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to investigate predictors for effective, safe fluid removal by furosemide in critically ill neonates and infants.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Furosemide bolus was classified as effective and safe if urine output within 2 h after administration exceeded 10 mL/kg/h and systolic blood pressure did not drop below 60 mmHg.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with an arterial line and urinary catheter who were administrated furosemide bolus were enrolled.
Key exclusion criteria
Furosemide boluses in patients meeting any of the following criteria were excluded: 1) patients undergoing any type of dialysis; 2) history of any type of congenital heart disease; 3) presence of complications known to affect urinary output, such as diabetes insipidus or severe hyperglycemia; 4) use of other diuretics (including furosemide) within 6 h preceding the index furosemide bolus; or 5) use of any kind of extra-corporeal circulation.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Natsuhiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL
0457872918
natsuyamamo@gmail.com
Public contact
Name of contact person
| 1st name | Natsuhiro |
| Middle name | |
| Last name | Yamamoto |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa 236-0004, Japan
TEL
0457872918
Homepage URL
natsuyamamo@gmail.com
Sponsor or person
Institute
Saitama Children's Medical Center
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
Institutional review board at Saitama Children's Medical Center
Address
1-2 Shintoshin, Chuou-ku, Saitama 330-8777, Japan
Tel
048-601-2200
natsuyamamo@gmail.com
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
| 2020 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
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
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Total 102 furosemide boluses administrated to 23 non-cardiac critically ill neonates and infants between April 1, 2017, and December 31, 2017 were analyzed.
Management information
Registered date
| 2020 | Year | 07 | Month | 09 | Day |
Last modified on
| 2020 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046875
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
