UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040283 |
|---|---|
| Receipt number | R000045958 |
| Scientific Title | Prospective observational study evaluating amino acid dynamics during continuous renal replacement therapy |
| Date of disclosure of the study information | 2020/05/07 |
| Last modified on | 2022/02/25 15:49:34 |
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Basic information
Public title
Prospective observational study evaluating amino acid dynamics during continuous renal replacement therapy
Acronym
Amino acid dynamics in patients receive continuous hemofiltration
Scientific Title
Prospective observational study evaluating amino acid dynamics during continuous renal replacement therapy
Scientific Title:Acronym
Amino acid dynamics in patients receive continuous hemofiltration
Region
| Japan |
Condition
Condition
Patients who undergo continuous hemofiltration
Classification by specialty
| Nephrology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate amino acid dynamics during continuous hemofiltration in patients who need continuous hemofiltration
Basic objectives2
Others
Basic objectives -Others
Survey
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amino acid concentration in the blood
Amino acid loss in the filtrate
Key secondary outcomes
- Thirty-nine amino acid concentrations in the blood
- Thirty-nine amino acid concentrations in the filtrate
- Urine volume
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with sepsis or acute kidney injury (KDIGO stage 1 or higher)
(2) Patients aged 18 years or older on the date of informed consent
(3) Patients who are able to provide written informed consent or whose legally acceptable representative is able to provide written informed consent
Key exclusion criteria
(1) Patients with liver failure
(2) Patients who need other blood purification therapy within 4 hours after the continuous hemofiltration is started
(3) Patients who need to change the conditions of continuous hemofiltration within 4 hours after the continuous hemofiltration is started
(4) Patients who need enteral nutrition or parenteral nutrition containing amino acids within 4 hours after the continuous hemofiltration is started
(5) Patients who are determined ineligible by the principal investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroomi |
| Middle name | |
| Last name | Tatsumi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
060-0061
Address
S1, W16-291 Chuo-ku, Sapporo
TEL
011-611-2111
tatsumi@qc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hiroomi |
| Middle name | |
| Last name | Tatsumi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
060-0061
Address
S1, W16-291 Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
http://sapmedicu.com/residents_research.html
tatsumi@qc4.so-net.ne.jp
Sponsor or person
Institute
Department of Intensive Care Medicine, Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Otsuka Pharmaceutical Factory, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Sapporo Medical University Hospital
Address
S1, W16 Chuo-ku, Sapporo
Tel
011-611-2111
rskk@sapmed.ac.jp
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
札幌医科大学附属病院
Sapporo Medical University Hospital
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 07 | 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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
a prospective observational study
Management information
Registered date
| 2020 | Year | 05 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045958
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
