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

Study Overview
=================
Brief Summary
-----------------
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.

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.

Official Title
-----------------
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

Conditions
-----------------
Fluid Overload

Intervention / Treatment
-----------------
* Device: the wearable filtrating artificial Kidney Device
* Device: traditional hemodialysis machine


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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A（wearable filtrating artificial Kidney+traditional hemodialysis）<br>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<br>* the wearable filtrating artificial kidney device rapidly for rapid relief of fluid overload in patients<br>Device: traditional hemodialysis machine<br>* the hemodialysis machine currently used in clinical practice to reduce fluid overload in patients<br>|
| Experimental: Group B（traditional hemodialysis+wearable filtrating artificial Kidney）<br>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<br>* the wearable filtrating artificial kidney device rapidly for rapid relief of fluid overload in patients<br>Device: traditional hemodialysis machine<br>* the hemodialysis machine currently used in clinical practice to reduce fluid overload in patients<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Wearable, Artificial Kidney Device, Fluid Overload