Clinical Research Directory

Evaluation of the Effectiveness of a Mobile Application Developed for Hemodialysis Patients.

This study aims to evaluate the effectiveness of a mobile health application developed for adult patients undergoing hemodialysis treatment. The mobile application includes modules on adherence to medication, diet, and fluid restrictions, symptom management (fatigue, pain, itching), nutrition guidance, exercise recommendations, and motivational content. It also features reminder notifications, an "Ask the Expert" module, and personal symptom tracking. The research will be conducted as a single-center, single-blind, randomized controlled experimental study. Participants will be assigned to intervention and control groups using block randomization. The intervention group will receive the mobile application, while the control group will receive standard care. Assessments will be carried out at baseline (T0), 1st month (T1), and 2nd month (T2). The measurement tools to be used include the End-Stage Renal Disease Adherence Questionnaire (ESRD-AQ), Post-Dialysis Fatigue Scale, 5-D Itch Scale, Visual Analog Scale (VAS) for pain, and the Mobile Application Usability Scale. In addition, clinical parameters such as serum potassium, phosphorus, and albumin will be evaluated. A total of 72 patients (36 intervention, 36 control) will be included in the study. This study aims to assess the impact of a mobile health application on treatment adherence, symptom management, and clinical parameters among hemodialysis patients, and to develop a digital health model that can be integrated into nursing care.

To Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN060 in ESRD Dialysis Patients

The primary objective of this study is to assess the safety and tolerability of KN060 in patients with end-stage renal disease on regular hemodialysis. The secondary objectives to evaluate the pharmacokinetic and pharmacodynamic properties of multiple doses of KN060; to evaluate the immunogenicity of KN060; and to explore the efficacy of KN060 in preventing dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis in patients with end-stage renal disease undergoing regular hemodialysis. The main questions it aims to answer are: * Whether KN060 is safe for ESRD dialysis patients * Pharmacokinetic characteristics of KN060 in ESRD dialysis patients * Whether KN060 can effectively prevent dialyzer and extracorporeal circuit thrombosis Researchers will evaluate the safety, tolerability, Pharmacokinetics and Pharmacodynamics profile, dialyzer and extracorporeal circuit thrombosis, arteriovenous fistula thrombosis of KN060 in ESRD dialysis patients Subjects will : * Eligible subjects will receive KN060 2.5 mg/kg every two weeks for a total of 6 doses. * Assessed for the number, incidence, and severity of AEs, dialyzer thrombus, extracorporeal circuit thrombus, arteriovenous fistula thrombus, and time to hemostasis at the arteriovenous fistula puncture site.

Impact of Bevel Orientation on Arteriovenous Fistula Puncture in Hemodialysis

End-stage renal disease (ESRD) is a condition in which the filtration function of the kidneys has deteriorated, necessitating dialysis or transplantation. With an aging population, the number of patients undergoing dialysis for CKD is constantly increasing. There are different types of dialysis treatment: hemodialysis and peritoneal dialysis. Hemodialysis involves exchanges between blood and a dialysate (a liquid used to purify blood) via a dialyzer (artificial filter), coordinated by a generator. This method requires a vascular approach, of which there are 3 types: the arteriovenous fistula (AVF), the arteriovenous graft and the central venous catheter. The AVF remains the vascular access of choice for hemodialysis sessions, and its preservation is an essential objective for patients with CKD. One of the major challenges for AVFs is to achieve a successful puncture, an act performed around 310 times a year per patient, for dialysis performed three times a week with double needles. This repeated procedure can cause damage to the AVF, leading to complications such as stenosis, thrombosis, aneurysm, superficial infection, hematoma, bleeding, parietal rupture or dissection. However, there is no official recommendation on the most conservative puncture technique for AVF. In view of the number of patients concerned and the recurrence of puncture, it would seem essential to evaluate the impact of bevel orientation on the occurrence of complications during dialysis by means of a randomized prospective study.

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

This multicenter, prospective observational study aims to evaluate the predictive value of carotid corrected flow time (FTc) and peak flow velocity variability (PFVV) for hypotension during maintenance hemodialysis. Conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital, the study will include adult patients (≥18 years) with end-stage renal disease (ESRD) on long-term hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors affecting results will be excluded. Ultrasound assessments of FTc and PFVV will be performed once, at 1 hour after dialysis initiation. Blood pressure will be monitored during the procedure. The primary outcome is to determine the sensitivity, specificity, and optimal cutoff points of FTc and PFVV in predicting intradialytic hypotension. The estimated sample size is 183 participants, with analysis performed using ROC curves and multivariate regression. The protocol complies with ethical standards and aims to develop a simple, non-invasive, real-time tool to improve patient safety and individualized management during hemodialysis.

Inferior Vena Cava Collapsibility Index and Intradialytic Hypotension

This multicenter, prospective observational study aims to evaluate the predictive value of the Inferior Vena Cava Collapsibility Index (IVCCI), along with IVC maximum diameter (IVCmax) and IVC minimum diameter (IVCmin), for intradialytic hypotension in patients undergoing maintenance hemodialysis. The study will be conducted at The First Affiliated Hospital of Wannan Medical College, Wuhu City Second People's Hospital, Wuhu Hospital of Chinese Traditional Medicine, Wuhu Jinghu District Hospital, and Wuhu Guangji Hospital. Eligible participants are adults aged 18 years or older with diagnosed end-stage renal disease (ESRD), receiving regular hemodialysis for at least three months. Patients with acute kidney injury, severe cardiac conditions, or other factors likely to influence results will be excluded. Ultrasound measurements of IVCCI, IVCmax, and IVCmin will be performed once, precisely at 1 hour after dialysis initiation. IVCmax will be measured during inspiration when the IVC is at its largest, and IVCmin during expiration when it is at its smallest. Blood pressure will be monitored continuously during the procedure. The primary objective is to assess the sensitivity, specificity, and optimal cutoff values of IVCCI, IVCmax, and IVCmin for predicting hypotension, aiming to provide a simple and non-invasive tool to facilitate personalized dialysis management and reduce intradialytic hypotension. A sample size of 188 participants is estimated, with data analyzed using ROC curves and multivariate regression methods. The study protocol adheres to ethical standards and regulatory requirements, demonstrating potential to improve patient safety and treatment outcomes.

Pleth Variability Index for Predicting Low Blood Pressure During Maintenance Hemodialysis

What is this study about? We are studying whether the Pleth Variability Index (PVI)-a simple, non-invasive measurement from a pulse oximeter-can help predict low blood pressure (hypotension) during routine maintenance hemodialysis. Low blood pressure during dialysis is a common and potentially serious complication. Our goal is to find out if monitoring PVI can help identify patients at risk, so that early action can be taken. Who can join? Adults aged 18 to 80 years. Patients who have been receiving maintenance hemodialysis regularly for more than 3 months. Those who are willing and able to participate and sign an informed consent form. Who cannot join? Patients with severe heart rhythm problems, severe peripheral circulation problems, or swelling that makes PVI measurement unreliable. Patients who are pregnant or breastfeeding. Patients allergic to the dialysis filter or unable to cooperate with the study procedures. What will happen during the study? PVI Measurement: Your PVI will be checked with a simple fingertip device before starting dialysis and again 30 minutes after dialysis begins. Blood Pressure Monitoring: Your blood pressure will be closely watched throughout the dialysis session. Data Collection: Information about your age, medical history, medications, lab results, dialysis settings, and other standard measurements will be recorded. What are the benefits and risks? Benefits: By identifying patients at higher risk for low blood pressure during dialysis, the study may lead to safer and more comfortable dialysis treatment in the future. Risks: All measurements used in this study are safe and non-invasive, with no extra risk compared to routine care. Your Rights and Safety Participation is completely voluntary-you may leave the study at any time without affecting your medical care. The study has been reviewed and approved by the hospital's ethics committee. Your privacy and personal data will be strictly protected.

Hemodialysis-Induced Renal Perfusion Decline: Unraveling the Pathophysiological Mechanisms Linking Intradialytic Circulatory Stress to Residual Renal Function Loss

Residual renal function (RRF) plays a critical role in quality of life and survival in hemodialysis (HD) patients but characteristically declines after the initiation of HD. Owing to incomplete understanding of the pathophysiology underlying RRF decline, protective strategies remain limited. The aim of this study was to characterize the changes in renal perfusion in incident HD patients with preserved RRF during dialysis sessions and to provide new strategies for RRF preservation.