Clinical trial NCT05852184: Hb Scope: A Multi-Center Validation Trial
Official title: Hb Scope: A Multi-Center Validation Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemoglobin
Hemodialysis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council
name: SEHA Kidney Care
name: Asia University Hospital
First posted: 2023-05-10
Enrollment: 504
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients receiving regular maintenance HD through an arteriovenous (AV) fistula or AV graft access in the three participating sites.

Brief summary: The global prevalence of end-stage renal disease (ESRD) was estimated ranging 5.3 to 9.7 million patients in 2017 and is a major healthcare cost driver in both developed and developing economies. The majority of patients with ESRD, approximately 90%, received in-center maintenance hemodialysis (HD). Although HD patients are under the close supervision of a nephrologist, they are vulnerable to anemia and substantial hemoglobin (Hb) variability, which are controversially associated with poor clinical outcomes, such as all-cause mortality. The contemporary narrow target hemoglobin level recommended in the KDIGO and KDOQI guidelines, despite the ongoing debates, poses a crucial challenge in maintaining the optimal hemoglobin level in HD patients.

The Big Data Center at China Medical University Hospital (CMUH) has developed a tool, Hb Scope APP, that can use the color of the HD tubing to predict real-time Hb levels by leveraging the smartphone's camera capacity and machine learning (ML) technology. The performance of the Hb Scope ML algorithm in predicting Hb \> 10 g/dL can reach an accuracy of 0.93 and an AUROC of 0.99 in the testing dataset. This opens an opportunity to establish a vibrant digital ecosystem for automatic anemia management.

Innovative ML tools must be appropriately regulated before these algorithms are adopted into clinical practice. Therefore, in the current validation study, we propose to do a multicenter validation trial for validating whether the Hb predicted by Hb Scope APP can achieve an area under the receiver operating curve (AUROC) of at least 0.80 in the adult HD populations from CMUH, Asia University Hospital (AUH) in Taiwan, and SEHA Kidney Care (SKC)-Central in the United Arab Emirates.


Eligibility criteria: Inclusion Criteria:

* Patients receiving regular maintenance HD in the three participating sites; AND
* Aged 20-90 years old; AND
* Received regular HD through an arteriovenous (AV) fistula or AV graft access; AND
* Use the Fresenius HD machine 4008/4008S and 5008/5008S.

Exclusion Criteria:

* Do not have last Hb level from labs within 1 month prior; OR
* Do not receive blood drawn for the true Hb level or do not have the true Hb level on the date of image taking by Hb Scope APP; OR
* Do not agree to participate.

Primary outcomes:
measure: Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of > 10 g/dL.
timeFrame: 2 months
Secondary outcomes:
measure: Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of < 8 g/dL.
timeFrame: 2 months
measure: Agreement between the lab-derived and the Hb Scope-derived Hb level at the dichotomous cutoff of > 12 g/dL.
timeFrame: 2 months
measure: Consistency between the lab-derived and Hb Scope-derived Hb continuous value.
timeFrame: 2 months
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Asia University Hospital
city: Abu Dhabi
country: United Arab Emirates
facility: SHEA Kidney Care
Study officials:
References: