UMIN-CTR Clinical Trial

Basic information
Public title	Outcomes of continuous renal replacement therapy: a multicenter retrospective observational study
Acronym	Outcomes of continuous renal replacement therapy: a multicenter retrospective observational study
Scientific Title	Outcomes of continuous renal replacement therapy: a multicenter retrospective observational study
Scientific Title:Acronym	Outcomes of continuous renal replacement therapy: a multicenter retrospective observational study
Region	Japan

Condition
Condition	Patients requiring continuous renal replacement therapy
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the outcomes of continuous renal replacement therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Temporal changes of blood electrolyte concentrations during continuous renal replacement therapy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients treated by continuous renal replacement therapy from March 2021 to March 2022 2) Patients with more than one daily test 24 hours after treatment initiation 3) Patients treated with SUBPACK-Bi or Sublood-BSG
Key exclusion criteria	Patients who refuse to participate in this study based on the optout
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Kent Middle name Last name Doi
Organization	The Univerity of Tokyo
Division name	Department of Emergency and Critical Care Medicine
Zip code	113-8654
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3812-2111
Email	kentdoi@m.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Yutaro Middle name Last name Inoue
Organization	The Univerity of Tokyo
Division name	Department of Emergency and Critical Care Medicine
Zip code	113-8654
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3812-2111
Homepage URL
Email	inouey-eme@h.u-tokyo.ac.jp

Sponsor
Institute	the University of Tokyo
Institute
Department

Funding Source
Organization	Nipro corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Office for Human Research Studies Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel	03-3812-2111
Email	ethics@m.u-tokyo.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

Other administrative information
Date of disclosure of the study information	2022 Year 03 Month 15 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	Preinitiation
Date of protocol fixation	2022 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date	2022 Year 03 Month 15 Day
Last follow-up date	2022 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Others

Management information
Registered date	2022 Year 03 Month 06 Day
Last modified on	2022 Year 03 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053718