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

Fluid Overload Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906355
• Other study ID #: S2022-120-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 25, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: Chinese PLA General Hospital
• Contact: Yang Qiaoqiao, doctor
• Phone: 18754800176
• Email: connie_az[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Overload

Intervention

Device:
• the wearable filtrating artificial Kidney Device
the wearable filtrating artificial kidney device rapidly for rapid relief of fluid overload in patients
• traditional hemodialysis machine
the hemodialysis machine currently used in clinical practice to reduce fluid overload in patients

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

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