Use of a Novel Artificial Intelligence Assisted Platform to Assess Optimal Dosing and Treatment Strategy of Erythropoiesis-stimulating Agents (ESA) in Hemodialysis Patients

End Stage Renal Disease on Dialysis Clinical Trial

— AI  

Official title:

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05032651
• Other study ID #: KMUHIRB-F(I)-20210040
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: December 23, 2023

Study information

• Verified date: June 2021
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Ping-Hsun Wu, PhD
• Phone: 07-3121101
• Email: 970392KMUH[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It has been known well for a long time that End stage renal disease (ESRD) patients usually need ESA to maintain their hemoglobin (Hb) to improve both mortality as well as quality of life. Later, several large-scale RCTs showing normalization of Hb in this population increased the risk of thromboembolic event, which leaded current guidelines to recommend the therapeutic goal for anemia in ESRD should be within a range (usually between 10-12 gm/dl) rather than above or below a certain level (or value). In addition to ESA dose, many factors contribute to the severity of anemia in this population, such as iron status, chronic blood loss, adequacy of dialysis, chronic inflammation, renal wasting, et al. To put all these factors together, maintaining the Hb levels within the target level is a challenge to physician. It was reported that only one third of Hb within the target at any given time. Our data showed, for those under maintenance hemodialysis and without any blood transfusion in observation period, near two third of patients' Hb level were within the target range.

Description:

For better anemia management, NKF-K/DOQI developed and published guidelines using protocol or algorithm for EPO prescription.6 Recently, artificial intelligence (AI) has been widely applied to medicine in the field of reducing human error, robotic surgical system and decision- making aid. Since then, there were several studies working on decision making programs to set up model of predicting the ESA dose needed for target Hb level. Artificial neural network (ANN) model is most commonly used for ESA dose-response prediction. However, the effectiveness of these kinds of AI is not confirmed clinically and the result not satisfactory. In other words, it is still inconclusive whether contemporary AI has any role in decision making aid when prescribing ESA dose for dialysis patient, a typical trial and error which AI supposed should be very helpful with. Based on the mentioned above, we are going to conduct this clinical try to test the hypothesis that AI is not inferior to physician in prescribing ESA dose for hemodialysis patients to maintain hemoglobin(Hb) level to meet the target

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 23, 2023
• Est. primary completion date: December 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. signed informed consent

2. Age older than 20 year old.

3. End stage renal disease under regular hemodialysis with three times per week and duration of each session at least 4 hours

4. Having at least consecutive 6 months data of both Hb and biochemical study during dialysis before enrollment and at least one Hb level within the range of 11-12 g/dl

5. Having at least one prescription of ESA supplement to keep Hb within the range of 10-12 g/dl in the past 6 months before the enrollment

6. Having received ESA of the same brand at least 6 months before the enrollment

Exclusion Criteria:

1. Ever receiving blood transfusion in the past 12 months

2. Active bleeding with blood loss more than 250cc in 3 months before the enrollment

3. Active infection or malignancy

4. Study subject can not follow with the study protocol End of Study The eligible subject will not be allowed to continue the study once informed consent is withdrawn or event happening meets the following criteria:

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Device:
• novel artificial intelligence assisted platform
Use of a novel artificial intelligence assisted platform

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)	Kaohsiung,

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	National Sun Yat-sen University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin (Hb) levels	Maintain hemoglobin at the treatment target of 10 g/dl to 12 g/dl.	6 monthes
Secondary	the target range (10-12gm/dl)	The Proportion of Participants with haemoglobin within the target range (10-12gm/dl)	6 monthes
Secondary	The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion	The Proportion of Participants Who Received a Whole Blood or Red Blood Cell Transfusion	6 monthes