NCT05906355

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

June 25, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

2.4 years

First QC Date

January 31, 2023

Last Update Submit

June 14, 2023

Conditions

Fluid Overload

Keywords

WearableArtificial Kidney DeviceFluid Overload

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • incidence of alarms of device

    4 hours

  • arterial pressure displayed by the device

    4 hours

  • venous pressure displayed by the device

    4 hours

  • patient satisfaction with the device

    4 hours

  • nurse satisfaction with the device

    4 hours

  • +2 more secondary outcomes

Study Arms (2)

Group A（wearable filtrating artificial Kidney+traditional hemodialysis）

EXPERIMENTAL

Group A was isolated ultrafiltration with wearable filtrating artificial Kidney Device first, and then with traditional hemodialysis machine.

Device: the wearable filtrating artificial Kidney DeviceDevice: traditional hemodialysis machine

Group B（traditional hemodialysis+wearable filtrating artificial Kidney）

EXPERIMENTAL

Group B was isolated ultrafiltration with traditional dialysis machine first, and then with wearable filtrating artificial Kidney Device.

Device: the wearable filtrating artificial Kidney DeviceDevice: traditional hemodialysis machine

Interventions

the wearable filtrating artificial Kidney DeviceDEVICE

the wearable filtrating artificial kidney device rapidly for rapid relief of fluid overload in patients

Group A（wearable filtrating artificial Kidney+traditional hemodialysis）Group B（traditional hemodialysis+wearable filtrating artificial Kidney）
traditional hemodialysis machineDEVICE

the hemodialysis machine currently used in clinical practice to reduce fluid overload in patients

Group A（wearable filtrating artificial Kidney+traditional hemodialysis）Group B（traditional hemodialysis+wearable filtrating artificial Kidney）

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Yang Qiaoqiao, doctor

CONTACT

18754800176connie_az@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2023

First Posted

June 15, 2023

Study Start

June 25, 2023

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

June 15, 2023

Record last verified: 2023-06

Locations

CN(1)