End Stage Renal DiseaseNCT05878171
Preference of Life-Sustaining Treatment Among Patients With End Stage Renal Disease
An observational study of End Stage Renal Disease, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Although patients with kidney disease can rely on dialysis to prolong their lives, the complexity of the disease, the variability of the course of the disease, and the uncertainty of the prognosis often delay the discussion of issues at the end of life, and the deterioration of the condition often makes it impossible… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- End Stage Renal Disease
- How many people
- 200 participants
- Where
- 2 sitesTaiwan
- Study dates
- 22 Apr 2023to 30 Apr 2025
- 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
- Adult, Older adult
Study population: Patients diagnosed with chronic kidney disease stage V or end-stage renal disease, and glomerular filtration rate less than 15ml/min/1.73m2; or patients receiving regular blood or peritoneal dialysis treatment.
Who may be able to join
- Over 20 years old.
- Patients diagnosed with chronic kidney disease stage V or end-stage renal disease, and glomerular filtration rate less than 15ml/min/1.73m2; or patients receiving regular blood or peritoneal dialysis treatment.
- Those who have normal cognitive function (such as: able to read newspapers and magazines, and communicate with others), and can communicate in Mandarin and Taiwanese.
Who cannot join
- Severe cognitive impairment or visual or hearing impairment that makes it impossible to answer questions.
- Critically ill patients.
- Patients with chronic mental illness or their related diagnosis records.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chun-Fu Lai, M.D., +886-2-23123456 ext. 63921, s821052@gmail.com
- Completed
National Taipei University of Nursing and Health Sciences
Taipei
About this study
Although patients with kidney disease can rely on dialysis to prolong their lives, the complexity of the disease, the variability of the course of the disease, and the uncertainty of the prognosis often delay the discussion of issues at the end of life, and the deterioration of the condition often makes it impossible for the patient to express clearly or rationally. Treatment thoughts or preferences. Sufficient time is needed to think and discuss issues related to life treatment. Discuss with patients as soon as possible to help draw up end-of-life care plans, help patients realize end-of-life care preferences, assist family members to make complex treatment decisions, and alleviate medical providers' moral distress. Domestic life-sustaining treatment research is mostly signed by DNR for cancer patients and retrospective investigation of medical records, and seldom focuses on kidney disease patients and life-sustaining treatment survey preferences other than DNR content. This study sought to understand patients with kidney disease's preferences for life-sustaining care during disease progression, and to understand whether prognostic perceptions, symptom distress, dementia, and decision conflict affect patients' preferences. Pre-collected convenient sampling is expected to include 200 patients diagnosed with chronic kidney disease stage 5 or end-stage renal disease, including patients who have received regular dialysis. The survey will be conducted with a single questionnaire. There are five questionnaires, including: demographic characteristics, chronic kidney disease prognosis cognition And life-support treatment information questionnaire, short-form recall symptom assessment scale, loss of memory scale and decision-making conflict scale; after the researcher explains, the patient fills in by himself or the researcher fills in after the patient answers. It is expected that the results of the study will help clinical practitioners to understand the changes in the management of medical care for kidney disease patients when the disease worsens and assist in the management of patients' medical care, echoing the importance of advancing medical care planning in this population, for the future development of kidney disease A reference for care guidelines for debilitated patients, thereby improving care quality and satisfaction.
- Conditions
- End Stage Renal Disease
- Keywords
- Life-Sustaining Treatment,End Stage Renal Disease,Preference
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference for end-of-life life-sustaining treatment for patients with end-stage renal disease
This study aimed to investigate end-stage renal disease treatment and end-of-life life-sustaining treatment preferences in patients with renal failure. Life-sustaining treatment preferences include cardiac resuscitation, endotracheal intubation, mechanical ventilation, blood transfusion, antibiotics, and artificial nutrition and fluids. And life support treatment preference is divided into three aspects: preference choice, clear understanding, and certainty for preference data investigation: (1) For each life support treatment preference choice, "absolutely", "maybe", "may not" " Never"; (2) Are you aware of your preferences for each life-sustaining treatment clearly enough to select a "yes" and "no" option; (3) Are you confident in choosing each life-sustaining treatment? "Yes" and "No" options.
Measured: one year
The influencing factors of life-sustaining treatment preference in patients with end-stage renal disease
The life-sustaining treatment that patients with ESRD are willing to receive at the end of life will be affected by demographic characteristics, that is, collecting patients' sex, age, time of kidney disease diagnosis, frequency of dialysis, religion, occupational status and laboratory reports; prognostic perception will ask patients Self-prognosis expectations are less than 5 years, 5 to 10 years, greater than 10 years and uncertain; MSAS-SF is used to investigate the symptoms of patients within a week, and can also be compared with cancer and other diseases; Demoralization Scale-Mandarin Version is used to describe the degree of pain in the past two weeks, describe the pain of the patient, judge the severity of the patient's low morale, predict suicidal behavior, evaluate the quality of life and screen the diagnosis of depression but face survival crisis and lose the meaning of life of patients.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start22 Apr 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor
- Investigators
- Chan-Shiuan Kuo, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878171
- Sponsor's protocol ID
- 202303044RINC
- Status last verified
- Oct 2024
- First submitted
- 7 May 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: height and weight,BUN,Cre,eGFR, pH,HCO3,CO2,HB,WBC,Plt,CRP,Na,K,Ca,P,Alb,HBA1c,Cardiac ultrasound,Cardiac Catheterization,computed tomography
Publications
Saeed F, Sardar M, Rasheed K, Naseer R, Epstein RM, Davison SN, Mujtaba M, Fiscella KA. Dialysis Decision Making and Preferences for End-of-Life Care: Perspectives of Pakistani Patients Receiving Maintenance Dialysis. J Pain Symptom Manage. 2020 Aug;60(2):336-345. doi: 10.1016/j.jpainsymman.2020.03.009. Epub 2020 Mar 20.
PubMed 32201311O'Hare AM, Kurella Tamura M, Lavallee DC, Vig EK, Taylor JS, Hall YN, Katz R, Curtis JR, Engelberg RA. Assessment of Self-reported Prognostic Expectations of People Undergoing Dialysis: United States Renal Data System Study of Treatment Preferences (USTATE). JAMA Intern Med. 2019 Oct 1;179(10):1325-1333. doi: 10.1001/jamainternmed.2019.2879.
PubMed 31282920Bernacki GM, Engelberg RA, Curtis JR, Kurella Tamura M, Brumback LC, Lavallee DC, Vig EK, O'Hare AM. Cardiopulmonary Resuscitation Preferences of People Receiving Dialysis. JAMA Netw Open. 2020 Aug 3;3(8):e2010398. doi: 10.1001/jamanetworkopen.2020.10398.
PubMed 32833017Saeed F, Sardar MA, Davison SN, Murad H, Duberstein PR, Quill TE. Patients' perspectives on dialysis decision-making and end-of-life care . Clin Nephrol. 2019 May;91(5):294-300. doi: 10.5414/CN109608.
PubMed 30663974Scherer JS, Milazzo KC, Hebert PL, Engelberg RA, Lavallee DC, Vig EK, Kurella Tamura M, Roberts G, Curtis JR, O'Hare AM. Association Between Self-reported Importance of Religious or Spiritual Beliefs and End-of-Life Care Preferences Among People Receiving Dialysis. JAMA Netw Open. 2021 Aug 2;4(8):e2119355. doi: 10.1001/jamanetworkopen.2021.19355.
PubMed 34347059
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preference of Life-Sustaining Treatment Among Patients With End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT05878171
- Acronym / sponsor ID
- 202303044RINC
- Conditions
- End Stage Renal Disease
- Keywords
- Life-Sustaining Treatment,End Stage Renal Disease,Preference
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 26 May 2023 (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.
Although patients with kidney disease can rely on dialysis to prolong their lives, the complexity of the disease, the variability of the course of the disease, and the uncertainty of the prognosis often delay the discussion of issues at the end of life, and the deterioration of the condition often makes it impossible for the patient to express clearly or rationally. Treatment thoughts or preferences. Sufficient time is needed to think and discuss issues related to life treatment. Discuss with patients as soon as possible to help draw up end-of-life care plans, help patients realize end-of-life care preferences, assist family members to make complex treatment decisions, and alleviate medical providers' moral distress. Domestic life-sustaining treatment research is mostly signed by DNR for cancer patients and retrospective investigation of medical records, and seldom focuses on kidney disease patients and life-sustaining treatment survey preferences other than DNR content. This study sought to understand patients with kidney disease's preferences for life-sustaining care during disease progression, and to understand whether prognostic perceptions, symptom distress, dementia, and decision conflict affect patients' preferences. Pre-collected convenient sampling is expected to include 200 patients diagnosed with chronic kidney disease stage 5 or end-stage renal disease, including patients who have received regular dialysis. The survey will be conducted with a single questionnaire. There are five questionnaires, including: demographic characteristics, chronic kidney disease prognosis cognition And life-support treatment information questionnaire, short-form recall symptom assessment scale, loss of memory scale and decision-making conflict scale; after the researcher explains, the patient fills in by himself or the researcher fills in after the patient answers. It is expected that the results of the study will help clinical practitioners to understand the changes in the management of medical care for kidney disease patients when the disease worsens and assist in the management of patients' medical care, echoing the importance of advancing medical care planning in this population, for the future development of kidney disease A reference for care guidelines for debilitated patients, thereby improving care quality and satisfaction.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with chronic kidney disease stage V or end-stage renal disease, and glomerular filtration rate less than 15ml/min/1.73m2; or patients receiving regular blood or peritoneal dialysis treatment.
Key inclusion criteria (3 listed)
- Over 20 years old.
- Patients diagnosed with chronic kidney disease stage V or end-stage renal disease, and glomerular filtration rate less than 15ml/min/1.73m2; or patients receiving regular blood or peritoneal dialysis treatment.
- Those who have normal cognitive function (such as: able to read newspapers and magazines, and communicate with others), and can communicate in Mandarin and Taiwanese.
Key exclusion criteria (3 listed)
- Severe cognitive impairment or visual or hearing impairment that makes it impossible to answer questions.
- Critically ill patients.
- Patients with chronic mental illness or their related diagnosis records.
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
Preference for end-of-life life-sustaining treatment for patients with end-stage renal disease
Time frame: one year
This study aimed to investigate end-stage renal disease treatment and end-of-life life-sustaining treatment preferences in patients with renal failure. Life-sustaining treatment preferences include cardiac resuscitation, endotracheal intubation, mechanical ventilation, blood transfusion, antibiotics, and artificial nutrition and fluids. And life support treatment preference is divided into three aspects: preference choice, clear understanding, and certainty for preference data investigation: (1) For each life support treatment preference choice, "absolutely", "maybe", "may not" " Never"; (2) Are you aware of your preferences for each life-sustaining treatment clearly enough to select a "yes" and "no" option; (3) Are you confident in choosing each life-sustaining treatment? "Yes" and "No" options.
The influencing factors of life-sustaining treatment preference in patients with end-stage renal disease
Time frame: one year
The life-sustaining treatment that patients with ESRD are willing to receive at the end of life will be affected by demographic characteristics, that is, collecting patients' sex, age, time of kidney disease diagnosis, frequency of dialysis, religion, occupational status and laboratory reports; prognostic perception will ask patients Self-prognosis expectations are less than 5 years, 5 to 10 years, greater than 10 years and uncertain; MSAS-SF is used to investigate the symptoms of patients within a week, and can also be compared with cancer and other diseases; Demoralization Scale-Mandarin Version is used to describe the degree of pain in the past two weeks, describe the pain of the patient, judge the severity of the patient's low morale, predict suicidal behavior, evaluate the quality of life and screen the diagnosis of depression but face survival crisis and lose the meaning of life of patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Background: PubMed 32201311Saeed F, Sardar M, Rasheed K, Naseer R, Epstein RM, Davison SN, Mujtaba M, Fiscella KA. Dialysis Decision Making and Preferences for End-of-Life Care: Perspectives of Pakistani Patients Receiving Maintenance Dialysis. J Pain Symptom Manage. 2020 Aug;60(2):336-345. doi: 10.1016/j.jpainsymman.2020.03.009. Epub 2020 Mar 20.
- Results publication: PubMed 31282920O'Hare AM, Kurella Tamura M, Lavallee DC, Vig EK, Taylor JS, Hall YN, Katz R, Curtis JR, Engelberg RA. Assessment of Self-reported Prognostic Expectations of People Undergoing Dialysis: United States Renal Data System Study of Treatment Preferences (USTATE). JAMA Intern Med. 2019 Oct 1;179(10):1325-1333. doi: 10.1001/jamainternmed.2019.2879.
- Results publication: PubMed 32833017Bernacki GM, Engelberg RA, Curtis JR, Kurella Tamura M, Brumback LC, Lavallee DC, Vig EK, O'Hare AM. Cardiopulmonary Resuscitation Preferences of People Receiving Dialysis. JAMA Netw Open. 2020 Aug 3;3(8):e2010398. doi: 10.1001/jamanetworkopen.2020.10398.
- Results publication: PubMed 30663974Saeed F, Sardar MA, Davison SN, Murad H, Duberstein PR, Quill TE. Patients' perspectives on dialysis decision-making and end-of-life care . Clin Nephrol. 2019 May;91(5):294-300. doi: 10.5414/CN109608.
- Results publication: PubMed 34347059Scherer JS, Milazzo KC, Hebert PL, Engelberg RA, Lavallee DC, Vig EK, Kurella Tamura M, Roberts G, Curtis JR, O'Hare AM. Association Between Self-reported Importance of Religious or Spiritual Beliefs and End-of-Life Care Preferences Among People Receiving Dialysis. JAMA Netw Open. 2021 Aug 2;4(8):e2119355. doi: 10.1001/jamanetworkopen.2021.19355.
- Individual participant dataSharing planned: Yes. height and weight,BUN,Cre,eGFR, pH,HCO3,CO2,HB,WBC,Plt,CRP,Na,K,Ca,P,Alb,HBA1c,Cardiac ultrasound,Cardiac Catheterization,computed tomography
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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.
Chan-Shiuan Kuo principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by National Taiwan University Hospital at 2 sites 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 3 inclusion and 3 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 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Chan-Shiuan Kuo (+886-2-23123456 Ext. 262489, r785380@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preference for end-of-life life-sustaining treatment for patients with end-stage renal disease (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT05878171, which also lists 5 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 18 Oct 2024.