Renal DialysisNCT03140345
Integrative HD Vascular Access Assessment
An observational study of Renal Dialysis and Integrative Medicine, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
The aim of this two-year study is to explore the relationship among function of HVA, nail-fold capillaries and TCM constitutions based on hybridizing data mining techniques. This study will not only improve our understanding on the expressions of function of HVA, nailfold capillaries and tendency of TCM patterns, but… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Renal Dialysis, Integrative Medicine, Hemodialysis Access Failure
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jun 2017to 30 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult ESRD patients having HD in two hospitals in the north of Taiwan
Who may be able to join
- having ESRD and needing hemodialysis three times weekly, having undergone hemodialysis ≥ 3 months, speaking Chinese or Taiwanese, and agreeing for data to be collected and stored in a database for analysis
Who cannot join
- life expectancy ≤ 3 months, having a malignant tumor, having unstable hemodynamics, having had a cerebrovascular accident, having acute heart failure, having acute bronchitis with acute exacerbation, or having had a severe infection in the last three months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taipei University of Nursing and Health Sciences
Taipei, 112
Hui-Chu Chiang, Ph D, +886-2-28227101 ext. 3151, huichu@ntunhs.edu.tw
Wen-chen Lin, Ph D, 886-3-2654846, lin_wenchen@cycu.org.tw
About this study
Official title: Integrative Nursing Assessment on Hemodialysis Vascular Access
The aim of this two-year study is to explore the relationship among function of HVA, nail-fold capillaries and TCM constitutions based on hybridizing data mining techniques. This study will not only improve our understanding on the expressions of function of HVA, nailfold capillaries and tendency of TCM patterns, but also demonstrate the fundamental knowledge of a novel healthcare model on hemodialysis vascular access.
Read the detailed description
Background
The effectiveness of hemodialysis (HD) depends on HD vascular access (HVA). Individualized prevention based on TCM constitutions can help persons to restore balance and prevent disease. To prevent the negative development of HVA and maintain HVA patency, development of an integrative model of HVA should be an important issue in nephrological nursing. To establish an integrative healthcare model of HVA, the understanding of the relationships between the common TCM constitution patterns of HD patients and the functions of HVA must be improved. In traditional Chinese medicine (TCM), health is conceived as a balance among the elements of the body. Published articles revealed that vascular access surgery, hemodynamic disorder and HD might impact HVA and the microcirculation of HD patients. Hence, changes of hand microcirculation might may come with and indicate the degeneration of HVA.
Purpose
The aims of this two-year study are as follows.
- To identify major risk factors for the functions of HVA.
- To measure the microcirculation and constitutions of HD patients.
- To explore associations among risk factors for the functions of HVA, TCM constitutions and the characteristics of nail-fold capillaries.
- To propose an HVA assessment model.
Patient
The adult ESRD patients have HD in two hospitals in the north of Taiwan
Data collection
Following approval by the Institutional Review Board, all eligible adult ESRD patients having HD in two hospitals in the north of Taiwan will be invited to participate in the study, after its requirements have been clearly explained to them.
Medical record review, measurements of microcirculation, and TCM constitutions questionnaires, will be used to collect data of eligible patients who provide informed consent.
Demographics, comorbidities, concurrent medication, histories of HVA and HD, parameters related to the adequacy of dialysis, and blood biochemistry data will be retrieved retrospectively from nursing and medical records and entered into a database. The TCM constitution of participants will be measured by questionnaires.
Before dialysis, nail-fold microcirculation will be noninvasively measured using a vediocapillaroscopic device (MC-380, Computed Microcirculation System, Kowa Optics Corp., Taiwan). The equipment and measuring procedures will be explained to the subjects. A finger to be examined will be gently placed on a microscope base plate and held still for the duration of the measurement. Computerized image processing will be used to capture and analyze data. The following morphological data will be extracted: blood velocity, capillary density, capillary width, capillary length, and the presence of abnormal capillary morphology.To identify the common microcirculation patterns of HD patients, images of nail-fold capillary will be processed use a framework that was developed by Prof. K. P. Lin and colleagues.
Statistical analysis
All of the collected data will be entered into a database. The Statistical Package for the Social Sciences for Windows (SPSS Inc, Chicago, Ill) was used to perform statistical analyses. Baseline demographics, comorbidities, medication, the results of blood biochemistry tests, and parameters that are related to HD adequacy and access function are presented as means, standard deviation and proportions as appropriate. Associations between parameters regarding vascular access dysfunction and the other variables were analyzed using the t-test, one-way analysis of variance, and Pearson's correlation coefficients, as appropriate. P<0.05 was considered to indicate statistical significance.
Information regarding the function of HVA will be incomplete if some patients do not experience any HVA dysfunction for the duration of this study. Hence,techniques for censored and truncated data will be used to deal with the incomplete data. Regressions and appropriate survival analysis will be conducted to capture the distribution of the function of HVA, and to identify the independent predictors of HVA function. In this study, a novel hybridizing data mining techniques will be applied to reduce data uncertainty. The HD-index that was developed by Prof. K. Y. Huang will be used to filter out uncertain data and to improve the precision of the forecasting model.
- Keywords
- Hemodialysis, Microcirculation, Traditional Chinese Medicine, Hemodialysis vascular access
What is being measured
The primary outcome is the main question the study is designed to answer.
Patency of hemodialysis vascular access
Patency of hemodialysis vascular access is defined as 1) the interval from the time of access placement to the time of access abandonment, any patency reestablish intervention, or create new access; and 2) the number of hemodialysis vascular access dysfunction events. The time of access placement and the time of the intervention, as well as number of hemodialysis vascular access dysfunction events will be retrieved from medical records. The interval from the time of access placement to the intervention will be calculated in days.
Measured: through study completion, an average of 2 year
Secondary outcomes (5)
Nail-fold blood flow velocity of the hands of the paticipants
Nail-fold blood velocity will be measured noninvasively by a vediocapillaroscopic device. The unit of nail-fold blood velocity is um/sec. The difference between two hands and the difference among every measurement will be analyzed.
Measured: 2 years
Total vessel density of nail-fold capillary in the hands of participants.
Total vessel density of nail-fold capillary is the number of capillaries per mm*mm flied. The unit of nail-fold blood velocity is um/sec. The difference between two hands and the difference among every measurement will be analyzed.
Measured: 2 years
Diameter of nail-fold capillary in the hands of participants.
The width of nail-fold capillary in the hand with hemodialysis vascular access will be presented in um. The unit of nail-fold blood velocity is um/sec. The difference between two hands and the difference among every measurement will be analyzed.
Measured: 2 years
Abnormalities of nail-fold capillary in the hands of participants.
The number of microaneurysms, giant capillaries, neoangiogenic capillaries, capillary tortuosity, avascular areas, and hemorrhage will be counted and presented in number/ mm*mm. The unit of nail-fold blood velocity is um/sec. The difference between two hands and the difference among every measurement will be analyzed.
Measured: 2 years
Distribution of the traditional Chinese medicine constitution patterns of HD patients
Proportion of each TCM constitution patterns will be presented while the participants have been measured by the TCM Constitutions Questionnaire.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start7 Jun 2017
- Primary completion1 Oct 2019 (estimated)
- Study completion30 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Renal DialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiang, Hui-Chu, National Taipei University of Nursing and Health Sciences
- Investigators
- Hui-Chu Chiang, Principal investigator, College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140345
- Sponsor's protocol ID
- TCMG/NTUNHS105-B- 12-02
- Status last verified
- Jun 2017
- First submitted
- 16 Apr 2017
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.
PubMed 24183112Ocak G, Rotmans JI, Vossen CY, Rosendaal FR, Krediet RT, Boeschoten EW, Dekker FW, Verduijn M. Type of arteriovenous vascular access and association with patency and mortality. BMC Nephrol. 2013 Apr 4;14:79. doi: 10.1186/1471-2369-14-79.
PubMed 23557085Wu CC, Zhang G, Huang TC, Lin KP. Red blood cell velocity measurements of complete capillary in finger nail-fold using optical flow estimation. Microvasc Res. 2009 Dec;78(3):319-24. doi: 10.1016/j.mvr.2009.07.002. Epub 2009 Jul 30.
PubMed 19647002Wu CC, Lin WC, Zhang G, Chang CW, Liu RS, Lin KP, Huang TC. Accuracy evaluation of RBC velocity measurement in nail-fold capillaries. Microvasc Res. 2011 May;81(3):252-60. doi: 10.1016/j.mvr.2011.01.003. Epub 2011 Jan 19.
PubMed 21255589
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Nursing Assessment on Hemodialysis Vascular Access
- ClinicalTrials.gov ID
- NCT03140345
- Acronym / sponsor ID
- TCMG/NTUNHS105-B- 12-02
- Keywords
- Hemodialysis, Microcirculation, Traditional Chinese Medicine, Hemodialysis vascular access
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 7 Jun 2017 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 30 Nov 2019 (estimated)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this two-year study is to explore the relationship among function of HVA, nail-fold capillaries and TCM constitutions based on hybridizing data mining techniques. This study will not only improve our understanding on the expressions of function of HVA, nailfold capillaries and tendency of TCM patterns, but also demonstrate the fundamental knowledge of a novel healthcare model on hemodialysis vascular access.
Detailed description
Background
The effectiveness of hemodialysis (HD) depends on HD vascular access (HVA). Individualized prevention based on TCM constitutions can help persons to restore balance and prevent disease. To prevent the negative development of HVA and maintain HVA patency, development of an integrative model of HVA should be an important issue in nephrological nursing. To establish an integrative healthcare model of HVA, the understanding of the relationships between the common TCM constitution patterns of HD patients and the functions of HVA must be improved. In traditional Chinese medicine (TCM), health is conceived as a balance among the elements of the body. Published articles revealed that vascular access surgery, hemodynamic disorder and HD might impact HVA and the microcirculation of HD patients. Hence, changes of hand microcirculation might may come with and indicate the degeneration of HVA.
Purpose
The aims of this two-year study are as follows.
- To identify major risk factors for the functions of HVA.
- To measure the microcirculation and constitutions of HD patients.
- To explore associations among risk factors for the functions of HVA, TCM constitutions and the characteristics of nail-fold capillaries.
- To propose an HVA assessment model.
Patient
The adult ESRD patients have HD in two hospitals in the north of Taiwan
Data collection
Following approval by the Institutional Review Board, all eligible adult ESRD patients having HD in two hospitals in the north of Taiwan will be invited to participate in the study, after its requirements have been clearly explained to them.
Medical record review, measurements of microcirculation, and TCM constitutions questionnaires, will be used to collect data of eligible patients who provide informed consent.
Demographics, comorbidities, concurrent medication, histories of HVA and HD, parameters related to the adequacy of dialysis, and blood biochemistry data will be retrieved retrospectively from nursing and medical records and entered into a database. The TCM constitution of participants will be measured by questionnaires.
Before dialysis, nail-fold microcirculation will be noninvasively measured using a vediocapillaroscopic device (MC-380, Computed Microcirculation System, Kowa Optics Corp., Taiwan). The equipment and measuring procedures will be explained to the subjects. A finger to be examined will be gently placed on a microscope base plate and held still for the duration of the measurement. Computerized image processing will be used to capture and analyze data. The following morphological data will be extracted: blood velocity, capillary density, capillary width, capillary length, and the presence of abnormal capillary morphology.To identify the common microcirculation patterns of HD patients, images of nail-fold capillary will be processed use a framework that was developed by Prof. K. P. Lin and colleagues.
Statistical analysis
All of the collected data will be entered into a database. The Statistical Package for the Social Sciences for Windows (SPSS Inc, Chicago, Ill) was used to perform statistical analyses. Baseline demographics, comorbidities, medication, the results of blood biochemistry tests, and parameters that are related to HD adequacy and access function are presented as means, standard deviation and proportions as appropriate. Associations between parameters regarding vascular access dysfunction and the other variables were analyzed using the t-test, one-way analysis of variance, and Pearson's correlation coefficients, as appropriate. P<0.05 was considered to indicate statistical significance.
Information regarding the function of HVA will be incomplete if some patients do not experience any HVA dysfunction for the duration of this study. Hence,techniques for censored and truncated data will be used to deal with the incomplete data. Regressions and appropriate survival analysis will be conducted to capture the distribution of the function of HVA, and to identify the independent predictors of HVA function. In this study, a novel hybridizing data mining techniques will be applied to reduce data uncertainty. The HD-index that was developed by Prof. K. Y. Huang will be used to filter out uncertain data and to improve the precision of the forecasting model.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult ESRD patients having HD in two hospitals in the north of Taiwan
Key inclusion criteria (1 listed)
- having ESRD and needing hemodialysis three times weekly, having undergone hemodialysis ≥ 3 months, speaking Chinese or Taiwanese, and agreeing for data to be collected and stored in a database for analysis
Key exclusion criteria (1 listed)
- life expectancy ≤ 3 months, having a malignant tumor, having unstable hemodynamics, having had a cerebrovascular accident, having acute heart failure, having acute bronchitis with acute exacerbation, or having had a severe infection in the last three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patency of hemodialysis vascular access
Time frame: through study completion, an average of 2 year
Patency of hemodialysis vascular access is defined as 1) the interval from the time of access placement to the time of access abandonment, any patency reestablish intervention, or create new access; and 2) the number of hemodialysis vascular access dysfunction events. The time of access placement and the time of the intervention, as well as number of hemodialysis vascular access dysfunction events will be retrieved from medical records. The interval from the time of access placement to the intervention will be calculated in days.
5 secondary outcomes
Nail-fold blood flow velocity of the hands of the paticipants
Time frame: 2 years
Total vessel density of nail-fold capillary in the hands of participants.
Time frame: 2 years
Diameter of nail-fold capillary in the hands of participants.
Time frame: 2 years
Abnormalities of nail-fold capillary in the hands of participants.
Time frame: 2 years
Distribution of the traditional Chinese medicine constitution patterns of HD patients
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 24183112Al-Jaishi AA, Oliver MJ, Thomas SM, Lok CE, Zhang JC, Garg AX, Kosa SD, Quinn RR, Moist LM. Patency rates of the arteriovenous fistula for hemodialysis: a systematic review and meta-analysis. Am J Kidney Dis. 2014 Mar;63(3):464-78. doi: 10.1053/j.ajkd.2013.08.023. Epub 2013 Oct 30.
- Background: PubMed 23557085Ocak G, Rotmans JI, Vossen CY, Rosendaal FR, Krediet RT, Boeschoten EW, Dekker FW, Verduijn M. Type of arteriovenous vascular access and association with patency and mortality. BMC Nephrol. 2013 Apr 4;14:79. doi: 10.1186/1471-2369-14-79.
- Background: PubMed 19647002Wu CC, Zhang G, Huang TC, Lin KP. Red blood cell velocity measurements of complete capillary in finger nail-fold using optical flow estimation. Microvasc Res. 2009 Dec;78(3):319-24. doi: 10.1016/j.mvr.2009.07.002. Epub 2009 Jul 30.
- Background: PubMed 21255589Wu CC, Lin WC, Zhang G, Chang CW, Liu RS, Lin KP, Huang TC. Accuracy evaluation of RBC velocity measurement in nail-fold capillaries. Microvasc Res. 2011 May;81(3):252-60. doi: 10.1016/j.mvr.2011.01.003. Epub 2011 Jan 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Chu Chiang principal investigator
College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Dialysis and Integrative Medicine, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui-Chu Chiang, PI (+886-2-28227101 ext. 3151, huichu@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency of hemodialysis vascular access (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03140345, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.