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
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04095143 -
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
|
||
| Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
| Completed |
NCT05070819 -
Atrial Natriuretic Peptide in Assessing Fluid Status
|
N/A | |
| Withdrawn |
NCT04870073 -
Retrograde Autologous Priming and Mannitol for Reducing Hemodilution in Cardiac Surgery
|
Phase 3 | |
| Recruiting |
NCT02989051 -
Fluid Restriction Keeps Children Dry
|
Phase 2/Phase 3 | |
| Completed |
NCT00517127 -
Crystalloids Versus Colloids During Surgery
|
Phase 4 | |
| Completed |
NCT00852514 -
The Optimization of Blood Pressure and Fluid Status Control With Eight-Polar Bioelectrical Impedance Analysis
|
Phase 4 | |
| Not yet recruiting |
NCT05983549 -
Neutral Versus Liberal fLuId In Traumatic Brain Injury: a Randomised Controlled Trial
|
N/A | |
| Completed |
NCT03929471 -
Target Weight Correction and Vascular Stiffness in Hemodialysis Patients
|
N/A | |
| Recruiting |
NCT06071026 -
Hemodynamic Effects of Variations in Net Ultrafiltration Rate During Continuous Renal Replacement Therapy.
|
N/A | |
| Completed |
NCT02903316 -
Predicting Fluid Responsiveness in on Pump Coronary Artery Bypass Graft Using Extra Systoles
|
N/A | |
| Terminated |
NCT02458157 -
Forced Fluid Removal in High Risk Acute Kidney Injury
|
Phase 4 | |
| Completed |
NCT02325856 -
Application of Bioimpedance Spectroscopy in Taiwan Dialysis Patients
|
N/A | |
| Completed |
NCT01628731 -
Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease
|
Phase 3 | |
| Not yet recruiting |
NCT05647200 -
Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part II
|
N/A | |
| Completed |
NCT03768752 -
Diastolic Dysfunction and Interstitial Lung Edema in Septic Patients
|
||
| Terminated |
NCT03553394 -
Effects of Restrictive Fluid Strategy on Postoperative Oliguric Pancreatic Surgery Patients
|
N/A | |
| Completed |
NCT06097923 -
Implementation of Fluid Strategies Using Real-time Bioelectrical Analyzer in Surgical Intensive Care Unit (SICU)
|
N/A | |
| Recruiting |
NCT04215692 -
Lung Ultrasound-guided Fluid Therapy in Pediatric Intensive Care Unit Patients
|
N/A | |
| Not yet recruiting |
NCT03322410 -
Hydratation Status at Initiation of Peritoneal Dialysis: Study of the Role of Peritoneal Permeability
|
N/A |