Primary Clinical Evaluation of Wearable Filtrating Artificial Kidney Device for On-site Medical Rescue

A Prospective, Cross-over, Controlled Primary Clinical Evaluation of the Precision, Security, and Operability of Wearable Filtrating Artificial Kidney Device for On-site Medical Rescue

Fluid overload is a common feature of diseases such as heart failure and kidney injury, which can lead to pulmonary edema or even death if not treated in time. In order to rapidly relieve fluid overload in patients, a wearable filtrating artificial kidney device was developed. The purpose of this study is to evaluation of the precision, security, and operability of wearable filtrating artificial kidney device for on-site medical rescue.

Study Overview

• Status: Not yet recruiting
• Conditions: Fluid Overload
• Intervention / Treatment: Device: the wearable filtrating artificial Kidney Device; Device: traditional hemodialysis machine

Detailed Description

Background:Fluid overload into the tissue spaces of the body can lead to damage to multiple organs, mainly the heart, kidneys, lungs, and gastrointestinal system. Fluid overload can diminish myocardial function, induce maladaptive myocardial remodeling, and decrease coronary vascular reactivity, increasing the risk of myocardial ischemia. Increased interstitial fluid decreases renal capillary blood flow, leading to renal ischemia and acute renal failure. In the lungs, excess extravascular water impairs gas exchange, decreases pulmonary compliance, and significantly increases morbidity and mortality. Fluid overload can also lead to impaired liver function and prolonged wound healing, as well as being a risk factor for intra-abdominal hypertension, and edema of the intestinal wall can lead to decreased absorption, intestinal distention, and even intestinal obstruction.A wearable filtrating artificial kidney device has been developed to address volume overload in patients, and it has been evaluated for biosafety and animal testing, and third-party testing has been completed for device performance as required by Q/WLS 10101-2020. This study proposes to conduct human trials to evaluate its performance.

Methods: This is a prospective controlled study involving patients with fluid overload requiring ultrafiltration therapy. Inclusion criteria: 1. 18 years ≤ age ≤ 70 years, regardless of gender; 2. Patients with fluid overload requiring ultrafiltration therapy; 3. Patients voluntarily participated and obtained written informed consent signed by the patient or authorized delegate. Exclusion criteria: 1. Mechanical failure of the ultrafiltration access; 2. Presence of active infection; 3. Known HIV positivity; 4. Poor compliance with the regimen; 5. Other serious diseases, such as active or previously treated residual malignancy or systemic infection, cirrhosis, anemia (Hb < 70 g/L), and intractable hypertension. 6. History of alcohol and drug abuse (meaning use of illicit drugs); 7. Women of childbearing age who are pregnant or breastfeeding and do not agree to use effective contraception during the trial; 8. Any other condition that, in the opinion of the investigator, prevents the patient from participating in the trial.Primary Outcome Measure:(1)Precision of ultrafiltration:Ultrafiltration volume precision, ultrafiltration speed precision;(2).Security:Pressure alarm (times), bubble monitoring (times), sound and light alarm (times) and other machine indicators;patients' complaints of improvement, tolerance, comfort, etc.(3).Operability:Human-machine interaction, friendly interface, battery life, overall mass, main volume, portable features, etc.SPSS is applied for statistical analysis, and continuous variables are expressed as mean±standard deviation, and non-continuous variables are expressed as percentages. Comparisons between the two data are made by independent t-test or χ2 test, and P<0.05 is statistically significant.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Qiaoqiao, doctor; Phone Number: 18754800176; Email: connie_az@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1.18 years ≤ age ≤ 70 years, regardless of gender. 2.Patients with fluid overload requiring ultrafiltration therapy. 3.The patient voluntarily participates and has obtained written informed consent signed by the patient or authorized delegate.

Exclusion Criteria:

1. Mechanical failure of the ultrafiltration access.
2. Presence of an active infection.
3. Known HIV positivity.
4. Poor compliance and inability to follow the regimen.
5. Other serious medical conditions such as active, or previously treated residual malignancy or systemic infection, cirrhosis, anemia (Hb<70g/L), intractable hypertension, etc.
6. History of alcohol and drug abuse (defined as the use of illegal drugs)
7. Pregnancy or breastfeeding, women of childbearing age who do not agree to use effective contraception for the duration of the trial
8. Any other condition that, in the opinion of the investigator, prevents the patient from enrolling in the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A（wearable filtrating artificial Kidney+traditional hemodialysis）; Group A was isolated ultrafiltration with wearable filtrating artificial Kidney Device first, and then with traditional hemodialysis machine.	Device: the wearable filtrating artificial Kidney Device; the wearable filtrating artificial kidney device rapidly for rapid relief of fluid overload in patients; Device: traditional hemodialysis machine; the hemodialysis machine currently used in clinical practice to reduce fluid overload in patients
Experimental: Group B（traditional hemodialysis+wearable filtrating artificial Kidney）; Group B was isolated ultrafiltration with traditional dialysis machine first, and then with wearable filtrating artificial Kidney Device.	Device: the wearable filtrating artificial Kidney Device; the wearable filtrating artificial kidney device rapidly for rapid relief of fluid overload in patients; Device: traditional hemodialysis machine; the hemodialysis machine currently used in clinical practice to reduce fluid overload in patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrafiltration volume of device	Compare the ultrafiltration volume of wearable filtrating artificial Kidney and traditional hemodialysis machine	4 hours
ultrafiltration speed of device	Compare the ultrafiltration speed of wearable filtrating artificial Kidney and traditional hemodialysis machine	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of alarms of device	Compare the incidence of alarms of wearable filtrating artificial Kidney and traditional hemodialysis machine	4 hours
arterial pressure displayed by the device	Compare the arterial pressure displayed by wearable filtrating artificial Kidney and traditional hemodialysis machine	4 hours
venous pressure displayed by the device	Compare the venous pressure displayed by wearable filtrating artificial Kidney and traditional hemodialysis machine	4 hours
patient satisfaction with the device	Survey question asking for qualitative description of satisfaction	4 hours
nurse satisfaction with the device	Survey question asking for qualitative description of satisfaction	4 hours
weight of device	The weight of device is measured in kg	before hemodialysis
volume of device	The volume of device is measured in Length x width x height	before hemodialysis

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2023
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 31, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Wearable; Fluid Overload; Artificial Kidney Device
• Other Study ID Numbers: S2022-120-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No