UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006349 |
|---|---|
| Receipt number | R000007531 |
| Scientific Title | Plasma Neutrophil Gelatinase-Associated Lipocalin in ICU patients with acute renal failure |
| Date of disclosure of the study information | 2011/09/16 |
| Last modified on | 2012/07/03 22:03:59 |
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Basic information
Public title
Plasma Neutrophil Gelatinase-Associated Lipocalin in ICU patients with acute renal failure
Acronym
Plasma Neutrophil Gelatinase-Associated Lipocalin in ICU patients with acute renal failure
Scientific Title
Plasma Neutrophil Gelatinase-Associated Lipocalin in ICU patients with acute renal failure
Scientific Title:Acronym
Plasma Neutrophil Gelatinase-Associated Lipocalin in ICU patients with acute renal failure
Region
| Japan |
Condition
Condition
ICU patients with acute renal failure
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between plasma NGAL concentration and prognosis of acute renal failure in critically ill patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Is plasma NGAL data useful as a prognostic factor in ICU patients with acute renal failure?
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients meeting renal injury criteira of RIFLE classification (Serum creatinine x 2 or < 0.5 ml/kg/hour x 12 hours)
Key exclusion criteria
Patients refused blood sampling
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akinori Uchiyama |
Organization
Osaka University Hospital
Division name
Intensive care unit
Zip code
Address
2-15Yamadaoka Suita
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Osaka University Hospital
Division name
Intensive care unit
Zip code
Address
TEL
81-6-6879-5824
Homepage URL
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2011 | Year | 06 | Month | 01 | Day |
Other
Other related information
After the diagnosis of acute renal injury, blood is sampled once daily during ICU stay. Other clinical and laboratory data is obtained from the ordinary patient records of ICU.
Management information
Registered date
| 2011 | Year | 09 | Month | 15 | Day |
Last modified on
| 2012 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007531
