UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044783 |
|---|---|
| Receipt number | R000051150 |
| Scientific Title | Single lumen catheter versus double lumen catheter in hemodialysis trouble: Prospective, multicenter, open-label, randomized controlled trial |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2021/07/07 14:27:51 |
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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
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
totogoal1230@gmail.com
Sponsor or person
Institute
Niigata Universtiy
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051150
