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

Launched by CHINESE PLA GENERAL HOSPITAL · Jun 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new device called a wearable filtrating artificial kidney, designed to help patients who have fluid overload. Fluid overload can happen in certain medical conditions, like heart failure or kidney injury, and if not treated quickly, it can lead to serious health issues. The goal of this study is to see how well this device works in safely and effectively removing excess fluid in patients who need immediate treatment.

To participate in this trial, you need to be between 18 and 70 years old and have fluid overload that requires a specific type of treatment called ultrafiltration. If you decide to join, you'll need to give your written consent. However, some people may not be eligible, including those with certain infections, serious health conditions, or those who are pregnant or breastfeeding. If you qualify, you can expect to wear the device during the study and help researchers learn more about its effectiveness in emergency situations. This study is currently not recruiting participants yet, but it aims to improve care for patients dealing with fluid overload in the future.

Gender

ALL

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:
• • 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.