UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035843 |
|---|---|
| Receipt number | R000040830 |
| Scientific Title | A multi-institutional observational study on the outcomes after catheter placement for peritoneal dialysis |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2023/02/15 15:02:33 |
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Basic information
Public title
A multi-institutional observational study on the outcomes after catheter placement for peritoneal dialysis
Acronym
Outcomes after peritoneal dialysis catheter placement
Scientific Title
A multi-institutional observational study on the outcomes after catheter placement for peritoneal dialysis
Scientific Title:Acronym
Outcomes after peritoneal dialysis catheter placement
Region
| Japan |
Condition
Condition
End-stage kidney diseae
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
According to the evaluation criteria of ISPD guidelines, we will verify the safety of detention of peritoneal dialysis catheter in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Catheter patency at 1 year (censoring for death and elective modality change)
Key secondary outcomes
Bowel perforation less than one percentage
Significant hemorrhage less than one percentage
Exit site and tunnel infection within 30 days of catheter insertion less than five percentage
Peritonitis within 30 days of catheter insertion less than five percentage
Functional catheter problem requiring manipulation or replacement or leading to technique failure less than twenty percentage
Frequency of leakage and surgical site infection
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
Patients who wish to undergo peritoneal dialysis with end-stage kidney disease
Key exclusion criteria
Patient who can not obtain informed consent
Patients who are considered to have no ability to judge
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Sakurada |
Organization
St. Marianna University School of Medicine
Division name
Nephrology and Hypertension
Zip code
216-8511
Address
2-16-1 Sugao Miyamae-ku Kawasaki
TEL
+81-44-977-8111
sakurada@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Sakurada |
Organization
St. Marianna University School of Medicine
Division name
Nephrology and Hypertension
Zip code
216-8511
Address
2-16-1 Sugao Miyamae-ku Kawasaki
TEL
+81-44-977-8111
Homepage URL
sakurada@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Nephrology and Hypertension
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical ethics committee of St. Marianna University School of Medicine
Address
2-16-1 Sugao Miyamae-ku, Kawasaki
Tel
+81-44-977-8111
k-sienbu.mail@marianna-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000040830
Publication of results
Partially published
Result
URL related to results and publications
https://www.kwcs.jp/jspd2022/index.html
Number of participants that the trial has enrolled
428
Results
Postoperatively, no major bleeding requiring blood transfusion or surgical intervention was observed, and intestinal perforation was observed in 2 patients (0.5%). Of the 420 patients who had the exit site, 34 (8.1%) had exit site and tunnel infection within 30 days, and 7 (1.7%) had peritoneal dialysis related peritonitis. The 1-year catheter survival rate without catheter removal, replacement, or any surgical or radiological intervention for catheter malfunction or irreparable drainage pain was 93.7%.
Results date posted
| 2023 | Year | 02 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age 66 (median), male 68.5%, diabetes 41.1%, history of cardiovascular disease 25.0%, BMI 23.2kg/m2 (median), eGFR 6.4ml/min/1.73m2 (median), serum albumin 3.6g/dl (median), hemoglobin 10.3g/dl (median), CRP 0.14g/dl (median)
Participant flow
Patients with end-stage renal disease who were to undergo peritoneal dialysis were enrolled, except for those who did not give consent or who were considered to be incapable of making a decision.
Adverse events
This study is a prospective observational study, not an interventional study, so no adverse events occurred.
Outcome measures
Rate of severe bleeding requiring postoperative blood transfusion or surgical intervention
Rate of visceral injuries including intestinal perforation
Rate of exit site and tunnel infection within 30 days after surgery
Rate of peritonitis within 30 days after surgery.
Survival analysis for non-perioperative infection
1-year catheter survival rate without catheter removal, replacement, or any surgical or radiological intervention for catheter malfunction or irreparable drainage pain
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we have established a two-year registration period, and the observation period is one year. Patients who discontinued peritoneal dialysis within one year will also investigate the reasons.
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040830
