Status Approved
First Submitted Date
2021/02/23
Registered Date
2021/03/04
Last Updated Date
2021/02/23
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0005958 |
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Unique Protocol ID | HKS 2020-03-023-002 |
Public/Brief Title | Comparative effect of plastic needle vs metal needle on high-convection volume hemodiafiltration |
Scientific Title | Comparative effect of plastic needle vs metal needle on high-convection volume hemodiafiltration |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | HKS 2020-03-023-002 |
Approval Date | 2020-05-29 |
Institutional Review Board Name | Hallym University Kangnam Sacred Heart Hospital Institution Review Board |
Institutional Review Board Address | 1, Singil-ro, Yeongdeungpo-gu, Seoul, |
Institutional Review Board Telephone | 02-829-5527 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Young-Ki Lee |
Title | MD, PhD |
Telephone | +82-2-829-5214 |
Affiliation | Hallym University Medical Center-Kangnam |
Address | 1, Singil-ro, Yeongdeungpo-gu, Seoul, |
Contact Person for Public Queries | |
Name | Do Hyoung Kim |
Title | MD. PhD |
Telephone | +82-2-829-5123 |
Affiliation | Hallym University Medical Center-Kangnam |
Address | 1, Singil-ro, Yeongdeungpo-gu, Seoul, |
Contact Person for Updating Information | |
Name | Do Hyoung Kim |
Title | MD. PhD |
Telephone | +82-2-829-5123 |
Affiliation | Hallym University Medical Center-Kangnam |
Address | 1, Singil-ro, Yeongdeungpo-gu, Seoul, |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-02-17 Actual | |
Target Number of Participant | 30 | |
Primary Completion Date | 2021-12-31 , Anticipated | |
Study Completion Date | 2021-12-31 , Anticipated | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Hallym University Medical Center-Kangnam | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2021-02-17 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | Hallym University Medical Center- Chuncheon | |
Recruitment Status | Not yet recruiting | |
Date of First Enrollment | 2021-02-26 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Hallym University Medical Center-Kangnam |
Organization Type | Medical Institute |
Project ID | HKS 2020-03-023-002 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Hallym University Medical Center-Kangnam |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Background and purpose: An inverse relationship was demonstrated between the magnitude of the convection volume and the mortality risk. However, some doubt exists as to whether these high volumes can be achieved in routine clinical practice because of the low blood flow rate. In this study we prospectively investigated how high-convection volume HDF can be performed in patients with end-stage renal failure receiving HDF at Gangnam Sacred Heart Hospital and Chuncheon Sacred Heart Hospital, compared to metal needles when using plastic needles. MATERIALS AND METHODS: We enrolled 30 patients with hemodialysis, prospectively. In a stepwise fashion, blood flow rate, needle size and dialysis membrane were optimized as much as possible in all patients. The blood flow was gradually increased (300 → 330 mL/min; step 1 and 2), and after the needle gauge was increased from 16 G to 15 G (step 3 and 4). After changing the needle from metal to plastic needle, the blood flow and needle gauge were increased in the same way (step 5, 6, 7 and 8). Expected Results: In this study, we intend to determine whether high-convection volume HDF can be performed and to identify factors affecting high-convection volume to establish a method for implementing high convection volume HDF in clinical practice. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Single Group |
Blinding/Masking | Open |
Allocation | Not Applicable |
Intervention Type | /Procedure/Surgery |
Intervention Description | A study comparing the effects of dialysis before and after step-by-step intervention in a single group during hemodiafiltration. Control blood flow during hemodialysis (blood flow 300ml/min, 330ml/min) Step-by-step control), and mediation is performed through the selection of needle gauge (16G or 15G) and plastic needle or metal needle used for hemodialysis. |
Number of Arms | 1 |
Arm 1 |
Arm Label Hemodiafiltration group before and after step application |
Target Number of Participant 30 |
|
Arm Type Others |
|
Arm Description A study comparing the effects of dialysis before and after step-by-step intervention in a single group during hemodiafiltration. Control blood flow during hemodialysis (blood flow 300ml/min, 330ml/min) Step-by-step control), and mediation is performed through the selection of needle gauge (16G or 15G) and plastic needle or metal needle used for hemodialysis. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (N00-N99)Diseases of the genitourinary system (N18.5)Chronic kidney disease, stage 5 End stage renal disease on hemodiafiltration |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 18Year~No Limit |
|
Description 1) Adult patients over 18 years old 2) Patients undergoing hemofiltration dialysis 3 times a week |
|
Exclusion Criteria |
1) Dialysis time is less than 4 hours |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Ratio of high-flow hemodialysis in each dialysis condition (substitution volume 21L or more) |
|
Timepoint | At the time end of each stage |
|
Secondary Outcome(s) 1 | ||
Outcome | Change in Kt/V and change in beta 2 microglobulin removal rate |
|
Timepoint | At the end of the final stage |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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