UMIN-CTR Clinical Trial

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
Email	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
Email	tatsumi@qc4.so-net.ne.jp

Sponsor
Institute	Department of Intensive Care Medicine, Sapporo Medical University School of Medicine
Institute
Department

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
Email	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	Open public recruiting
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	2020 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.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
Registered date	File name

Contact us.