UMIN-CTR Clinical Trial

Basic information
Public title	Does the response in urine output to a small dose of furosemide predict organ failure after achievement of negative fluid balance in acute respiratory failure ?
Acronym	Furosemide stress test to predict tolerance to negative fluid balance
Scientific Title	Does the response in urine output to a small dose of furosemide predict organ failure after achievement of negative fluid balance in acute respiratory failure ?
Scientific Title:Acronym	Furosemide stress test to predict tolerance to negative fluid balance
Region	Japan

Condition
Condition	acute respiratory failure
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective was to evaluate the ability of a furosemide stress test to predict tolerance of negative fluid balance (NFB) in patients with acute respiratory failure.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Poor tolerance of negative fluid balance in 24 hours Poor tolerance of negative fluid balance was evaluated by the development of hypotension, or the need for fluid expansion, or the need for vasopressors. When NFB was induced by furosemide, acute kidney injury was also considered as a criterion of poor tolerance.
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
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Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Mechanically ventilated patients who have been endotracheally intubated for respiratory failure with hemodynamic stability were included
Key exclusion criteria	(1) baseline estimated glomerular filtration rate (eGFR) <30 ml/minute/1.73m2; (2) known pregnancy; (3) evidence of obstructive uropathy (for example, hydro-ureter) (4) patients with allergy or known sensitivity to loop diuretics (5) achievement of AKIN stage III criteria; (6) evidence of volume depletion at the time of furosemide administration
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name JUN KATAOKA
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Department of Critical Care Medicine
Zip code
Address	3-4-32, Todaijima, Urayasu-shi, Japan
TEL	047-351-3101
Email	rdcyc910@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name JUN KATAOKA
Organization	Tokyo Bay Urayasu Ichikawa Medical Center
Division name	Department of Critical Care Medicine
Zip code
Address	3-4-32, Todaijima, Urayasu-shi, Japan
TEL	047-351-3101
Homepage URL
Email	rdcyc910@yahoo.co.jp

Sponsor
Institute	Tokyo Bay Urayasu Ichikawa Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 04 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Results
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Results Delayed
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 01 Day
Date of IRB	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	urine output

Management information
Registered date	2017 Year 04 Month 26 Day
Last modified on	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031089