UMIN-CTR Clinical Trial

Basic information
Public title	Single lumen catheter versus double lumen catheter in hemodialysis trouble: Prospective, multicenter, open-label, randomized controlled trial
Acronym	Single lumen catheter versus double lumen catheter in hemodialysis trouble: Prospective, multicenter, open-label, randomized controlled trial
Scientific Title	Single lumen catheter versus double lumen catheter in hemodialysis trouble: Prospective, multicenter, open-label, randomized controlled trial
Scientific Title:Acronym	Single lumen catheter versus double lumen catheter in hemodialysis trouble: Prospective, multicenter, open-label, randomized controlled trial
Region	Japan

Condition
Condition	ESRD
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Non-tunneled temporary hemodialysis catheter (NTHC) is required for urgent dialysis. Either one of single lumen catheter or double lumen catheter is used, but it is not inspected which one is more useful. We will compare safety, effectiveness, cost-benefit between these.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of blood removal failure in the six dialysis sessions after temporary catheter insertion
Key secondary outcomes	safety cost-effectiveness dialysis efficiency abnormal test value

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Use of single lumen catheter in the six dialysis sessions
Interventions/Control_2	Use of double lumen catheter in the six dialysis sessions
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 end-stage renal disease who need blood purification therapy even temporarily and the doctor has determined that a non-cuff catheter needs to be inserted into the right internal jugular vein. (2) Of the above, patients who are expected to undergo hemodialysis for at least 2 weeks (6 times in total) after insertion. (3) Patients who have obtained written consent. (4) Adult patients.
Key exclusion criteria	(1) Patients with a catheter inserted in the intensive care unit. (2) Patients with severe congestive heart failure who require oxygen administration. (3) Patients whose doctor has determined that it is necessary to insert a lumen catheter that exceeds the double lumen. (4) Patients who the doctor has determined that a catheter needs to be inserted into a blood vessel other than the right internal jugular vein. (5) Patients who undergo special blood purification therapy such as plasma exchange. (6) Patients with infection. (7) Patients with cancer cachexia. (8) Patients with known coagulation abnormalities. (9) Patients who are using anticoagulants other than undifferentiated heparin and low molecular weight heparin during hemodialysis. (10) Patients with hybrid hemodialysis who perform peritoneal dialysis and weekly hemodialysis. (11) Other patients who the doctor in charge judged inappropriate to participate in this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Tadashi Middle name Last name Otsuka
Organization	Niigata University Medical and Dental Hospital
Division name	Divison of nephrology and rheumatology
Zip code	951-8510
Address	Asahimachidori1-757 chuouku Niigata city Niigata prefecture
TEL	025-227-2200
Email	totogoal1230@gmail.com

Public contact
Name of contact person	1st name Tadashi Middle name Last name Otsuka
Organization	Niigata University Medical and Dental Hospital
Division name	Divison of nephrology and rheumatology
Zip code	951-8510
Address	Asahimachidori1-757 chuouku Niigata city Niigata prefecture
TEL	025-227-2200
Homepage URL
Email	totogoal1230@gmail.com

Sponsor
Institute	Niigata Universtiy
Institute
Department

Funding Source
Organization	Divison of nephrology and rheumatology , Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Nagaoka chuo hospital Tachikawa general hospital Jyouetsu general hospital Sado general hospital Uonuma institute of community hospital Ojiya sougou hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Niigata University Ethics Committee
Address	Asahimachidori1-757 chuouku Niigata city Niigata prefecture
Tel	025-227-2625
Email	ethics@adm.niigata-u.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	長岡中央綜合病院（新潟県） 立川総合病院（新潟県） 上越総合病院（新潟県） 佐渡総合病院（新潟県） 魚沼基幹病院（新潟県） 小千谷総合病院（新潟県）

Other administrative information
Date of disclosure of the study information	2021 Year 07 Month 31 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	2021 Year 03 Month 11 Day
Date of IRB	2021 Year 03 Month 12 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 07 Day
Last modified on	2021 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051150