Chronic Kidney DiseaseNCT02832518
Analyse Cardio-respiratory Patterns in Order to Early Detect the Clinical Complications in the Hemodialysis Patients
An observational study of Chronic Kidney Disease, run by Taipei Medical University.
Trial summary
The incidence and prevalence of dialysis in Taiwan remains higher as compared to past several years. The number of dialysis reported about 6-7 million people each year and the 2014 full-year cost estimation was about 330 million NTDs. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Dec 2016
- How long will I take part?
- 6 Months
- 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: Patients under hemodialysis
Who may be able to join
- above 20 years old and under hemodialysis
Who cannot join
- patient with coronary artery disease or under treatment for coronary artery disease and patient with fever, any kind of infection, or taking antibiotics
About this study
Official title: Using Contact Free Sensor to Analyse Cardio-respiratory Patterns in Order to Early Detect the Clinical Complications in the Hemodialysis Patients.
The incidence and prevalence of dialysis in Taiwan remains higher as compared to past several years. The number of dialysis reported about 6-7 million people each year and the 2014 full-year cost estimation was about 330 million NTDs. According to age-standardized population statistics in 1995, the number of dialysis per million population in 2006 year were 372.2 people, 381.9 people in 2012 year and the annual growth rate of 0.43 percent recorded.
EarlySense system is certified by TFDA, FDA and many other countries, which consists of mainly two parts. One for the sensing element, which placed under the mattress and the other one is AC-powered display panel bed. This system has the ability to monitor the patients physiological functions just be in contact via bed. When the patient laid on bed, the sensor which is placed under the bed would detects heart rate, breathing rate and activity level as well as other physiological signals. The system is also able to distinguish between patients in bed and out of bed during the operation to save the patient's records and information (including heart rate, respiratory rate and level of activity, and may render trends). The system is also have capability for real-time data transmission information which includes a warning to the nurses' station or other monitoring center of the screen by providing real-time information to nurse.
In this research project, we will use EarlySense equipment for continuous monitoring the dialysis patient's physiological data along with clinical data such as A. acute complications such as rapid changes in blood pressure, respiratory rate, movements of patients and Nausea or vomiting, etc phenomenon's) B. Lab examination data C. Status of patient whether patients hospitalized or not and patient death occurred or not. The study is expected to have a pilot study for more than three months' duration. Through this EarlySense continuous monitoring and gather the data, we will analyse to develop a prediction model and confirmed with indicators. Evidences from these analytics would help to propose ways to improve it and implement Positive predictive validity models.
- Conditions
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients under hemodialysis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac arrest
Measured: 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Tatung medical & healthcare technologies
- Responsible party
- Sponsor
- Investigators
- Shabbir Syed-Abdul, MD, MSc, PhD, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832518
- Sponsor's protocol ID
- N201512031
- Status last verified
- Jul 2016
- First submitted
- 12 Jul 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Contact Free Sensor to Analyse Cardio-respiratory Patterns in Order to Early Detect the Clinical Complications in the Hemodialysis Patients.
- ClinicalTrials.gov ID
- NCT02832518
- Acronym / sponsor ID
- N201512031
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Collaborators
- Tatung medical & healthcare technologies
- Study start
- Mar 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- 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 incidence and prevalence of dialysis in Taiwan remains higher as compared to past several years. The number of dialysis reported about 6-7 million people each year and the 2014 full-year cost estimation was about 330 million NTDs. According to age-standardized population statistics in 1995, the number of dialysis per million population in 2006 year were 372.2 people, 381.9 people in 2012 year and the annual growth rate of 0.43 percent recorded.
EarlySense system is certified by TFDA, FDA and many other countries, which consists of mainly two parts. One for the sensing element, which placed under the mattress and the other one is AC-powered display panel bed. This system has the ability to monitor the patients physiological functions just be in contact via bed. When the patient laid on bed, the sensor which is placed under the bed would detects heart rate, breathing rate and activity level as well as other physiological signals. The system is also able to distinguish between patients in bed and out of bed during the operation to save the patient's records and information (including heart rate, respiratory rate and level of activity, and may render trends). The system is also have capability for real-time data transmission information which includes a warning to the nurses' station or other monitoring center of the screen by providing real-time information to nurse.
In this research project, we will use EarlySense equipment for continuous monitoring the dialysis patient's physiological data along with clinical data such as A. acute complications such as rapid changes in blood pressure, respiratory rate, movements of patients and Nausea or vomiting, etc phenomenon's) B. Lab examination data C. Status of patient whether patients hospitalized or not and patient death occurred or not. The study is expected to have a pilot study for more than three months' duration. Through this EarlySense continuous monitoring and gather the data, we will analyse to develop a prediction model and confirmed with indicators. Evidences from these analytics would help to propose ways to improve it and implement Positive predictive validity models.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients under hemodialysis | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients under hemodialysis
Key inclusion criteria (1 listed)
- above 20 years old and under hemodialysis
Key exclusion criteria (1 listed)
- patient with coronary artery disease or under treatment for coronary artery disease and patient with fever, any kind of infection, or taking antibiotics
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
Cardiac arrest
Time frame: 6 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2016.
- 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.
Shabbir Syed-Abdul, MD, MSc, PhD study chair
Taipei Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Taipei Medical University.
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 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac arrest (time frame: 6 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2016.