Peritoneal Dialysis (PD)NCT07724327
A Simulated Case Study of a Peritoneal Dialysis-Specialized Large Language Model Assisting Doctors in Improving Decision-Making in Peritoneal Dialysis Management
A study testing Peritoneal dialysis-specialized large language model. in people with Peritoneal Dialysis (PD) and Large Language Models, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
This study is a randomized controlled trial based on simulated clinical cases, aiming to establish a standardized evaluation system for PD physicians, to assess the differences in PD management quality between a workflow assisted by a PD-specialized large language model and physician-only decision-making, and to… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Dialysis (PD), Large Language Models
- What is being tested?
- Peritoneal dialysis-specialized large language model.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Internal medicine or nephrology standardized training residents, licensed residents, or attending physicians.
- Independent experience in PD management ≤ 3 years.
- Provided signed informed consent and agreed to comply with the trial procedures.
Who cannot join
- Direct involvement in the development or training of the specialized PD large language model, or in the construction of the clinical scenarios/ scoring criteria used in this trial.
- Participation in the pilot testing of all clinical scenarios used in this trial.
- Inability or unwillingness to access the study platform or use online resources during the study period.
- Experienced PD experts.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Generative AI-Assisted Understanding and Decision Enhancement in Peritoneal Dialysis: A Randomized Controlled Trial (The GUIDE-PD Trial)
This study is a randomized controlled trial based on simulated clinical cases, aiming to establish a standardized evaluation system for PD physicians, to assess the differences in PD management quality between a workflow assisted by a PD-specialized large language model and physician-only decision-making, and to identify potential risks (such as generating obviously erroneous or even harmful recommendations). This simulated clinical case framework not only supports standardized and blinded evaluation, but also provides preliminary evidence for the model's effectiveness and safety before its deployment in real clinical settings, while avoiding direct impact on real patients.
- Conditions
- Peritoneal Dialysis (PD), Large Language Models
- Being tested
- Peritoneal dialysis-specialized large language model.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal dialysis-specialized large language model.Other
The peritoneal dialysis-specialized large language model (PD-LLM) used in this study was jointly developed by the Department of Nephrology at the First Affiliated Hospital of Sun Yat-sen University and Digital Health China (DHC).
| Study group | Role | What they receive |
|---|---|---|
| Phys Group | No intervention | Participants could search for relevant knowledge, but access to large language model (LLM)-related websites was prohibited. Participants will be invited to test again with the assistance of PD-LLM after 1-2 months of washout. |
| Phys+PD-LLM Group | Experimental | Participants had access to the web and a specialized PD-LLM provided by the First Affiliated Hospital of Sun Yat-sen University. Receives: Other: Peritoneal dialysis-specialized large language model. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management Reasoning
Percent correct (range: 0 to 100) for each case.
Measured: Within the 120-minute test period of the first test.
Secondary outcomes (5)
Domain-Specific Scores
Percent correct (range: 0 to 100) for each case in each domain.
Measured: Within the 120-minute test period of the first test.
Severity of Potential Harm
The severity of potential harm will be classified as none, mild-to-moderate, or severe.
Measured: Within the 120-minute test period of the first test.
Time per Scenario Case
The time (in seconds) participants spend per case.
Measured: Within the 120-minute test period of the first test.
Self-Reported Confidence per Case
Scale 1-10. 10 represents being very confident.
Measured: Within the 120-minute test period of the first test.
Difference between the Phys group's scores when tested with PD-LLM assistance and when assisted only by traditional search methods
range from -100 to 100
Measured: After 1-2 months of washout of first test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis (PD)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Vantive Health LLC
- Responsible party
- Principal investigator, Wei Chen, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724327
- Sponsor's protocol ID
- IIT-2026-511
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generative AI-Assisted Understanding and Decision Enhancement in Peritoneal Dialysis: A Randomized Controlled Trial (The GUIDE-PD Trial)
- ClinicalTrials.gov ID
- NCT07724327
- Acronym / sponsor ID
- IIT-2026-511
- Conditions
- Peritoneal Dialysis (PD), Large Language Models
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Vantive Health LLC
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Jul 2026 (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.
This study is a randomized controlled trial based on simulated clinical cases, aiming to establish a standardized evaluation system for PD physicians, to assess the differences in PD management quality between a workflow assisted by a PD-specialized large language model and physician-only decision-making, and to identify potential risks (such as generating obviously erroneous or even harmful recommendations). This simulated clinical case framework not only supports standardized and blinded evaluation, but also provides preliminary evidence for the model's effectiveness and safety before its deployment in real clinical settings, while avoiding direct impact on real patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phys Group | No intervention | –Participants could search for relevant knowledge, but access to large language model (LLM)-related websites was prohibited. Participants will be invited to test again with the assistance of PD-LLM after 1-2 months of washout. |
| Phys+PD-LLM Group | Experimental | Other: Peritoneal dialysis-specialized large language model.Participants had access to the web and a specialized PD-LLM provided by the First Affiliated Hospital of Sun Yat-sen University. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Internal medicine or nephrology standardized training residents, licensed residents, or attending physicians.
- Independent experience in PD management ≤ 3 years.
- Provided signed informed consent and agreed to comply with the trial procedures.
Key exclusion criteria (4 listed)
- Direct involvement in the development or training of the specialized PD large language model, or in the construction of the clinical scenarios/ scoring criteria used in this trial.
- Participation in the pilot testing of all clinical scenarios used in this trial.
- Inability or unwillingness to access the study platform or use online resources during the study period.
- Experienced PD experts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal dialysis-specialized large language model.The peritoneal dialysis-specialized large language model (PD-LLM) used in this study was jointly developed by the Department of Nephrology at the First Affiliated Hospital of Sun Yat-sen University and Digital Health China (DHC). | Other | Phys+PD-LLM Group |
Primary outcome
Management Reasoning
Time frame: Within the 120-minute test period of the first test.
Percent correct (range: 0 to 100) for each case.
5 secondary outcomes
Domain-Specific Scores
Time frame: Within the 120-minute test period of the first test.
Severity of Potential Harm
Time frame: Within the 120-minute test period of the first test.
Time per Scenario Case
Time frame: Within the 120-minute test period of the first test.
Self-Reported Confidence per Case
Time frame: Within the 120-minute test period of the first test.
Difference between the Phys group's scores when tested with PD-LLM assistance and when assisted only by traditional search methods
Time frame: After 1-2 months of washout of first test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal dialysis-specialized large language model. in people with Peritoneal Dialysis (PD) and Large Language Models, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 4 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: enrolling by invitation, as of the sponsor's last update on 24 Jul 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
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?
Management Reasoning (time frame: Within the 120-minute test period of the first test.). 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 24 Jul 2026.