SGLT2 Inhibition in Hemodialysis
Kidney FailureHemodialysis4 moreThe study is designed as a prospective randomized, controlled, double-blinded phase II trial to examine the effect of the SGLT2 inhibitor dapagliflozin, in comparison with placebo on cardiovascular outcome parameters in kidney failure patients undergoing replacement therapy with hemodialysis. The primary endpoint is the change (∆) in left ventricular mass indexed to body surface area (LVMi) from baseline to 6 months measured by cardiac magnetic resonance imaging. Null and alternative hypotheses: H0: There is no difference in the ∆ Left Ventricular Mass indexed to BSA after six months of treatment, comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo. H1: There is a difference in the ∆ Left Ventricular Mass indexed to BSA comparing patients having received the SGLT2-Inhibitor Dapagliflozin versus placebo.
Effect of Physical Exercise Performed Through Virtual Reality Games on Chronic Renal Patients During...
Renal InsufficiencyChronicPatients with chronic kidney diseases, especially those requiring hemodialysis, are characterized by an increased risk of numerous morbidities. This is a condition that significantly impacts the patient's quality of life, leads to dependence, and involves high-cost treatment. The physical condition of chronic kidney disease patients falls well below the recommendations set by the World Health Organization, indicating effective difficulties in the approaches used for implementing physical activity programs. New approaches must be considered. Physical activity through virtual reality can foster greater social integration of patients with physical exercise during hemodialysis, enabling improved quality of life and decreased frailty levels for these individuals due to its playful and motivational nature. Objective: To assess changes in heart rate variability modulation and the quality of life of chronic kidney disease patients undergoing virtual reality-based exercise during hemodialysis sessions. Methods: A longitudinal, controlled, randomized crossover clinical trial. The chronic kidney disease groups will be divided into two groups, Group A (GA) and Group B (GB). Group GA will engage in 10 interventions, with each intervention involving the completion of 3 sessions of a Virtual Reality (VR) game lasting 5 minutes each, totaling 15 minutes of exercise. Group GB will participate in 10 interventions, with each intervention comprising 15 minutes of physical exercise on a cycle ergometer, referred to here as conventional exercise. After the initial 10 interventions, the groups will switch exercises; that is, GA will cease VR interventions and begin another 10 interventions with conventional exercise, while GB will stop conventional exercise interventions and start another 10 interventions with VR. The Kidney Disease Quality of Life Short Form questionnaire, Beck's Anxiety and Depression Inventory, and the International Physical Activity Questionnaire will also be administered to all groups.
Potassium Supplementation in CKD
Renal InsufficiencyChronic3 moreThe current high-sodium, low-potassium diet contributes to the high prevalence of high blood pressure (hypertension). Indeed, the anti-hypertensive effects of potassium supplementation are well-established. Hypertension is even more prevalent and resistant in patients with chronic kidney disease (CKD) and contributes to further decline in kidney function. Four recent epidemiological studies (published 2014 - 2016) showed that higher dietary potassium intake was associated with better renal outcomes. All studies recommended an intervention study with potassium supplementation in patients with CKD, but this has not been performed. The aim of this study is to study the renoprotective effect of potassium supplementation in patients with CKD (stage 3b or 4, i.e. estimated glomerular filtration rate [eGFR] 15 - 45 ml/min/1.73 m2).
Efficiency and Safety of Paxlovid for COVID-19 Patients With Severe Chronic Kidney Disease
COVID-19Renal Insufficiency1 moreThis is a prospective, single-center, open and self-controlled study.The purpose of this study is to evaluate the efficacy and safety of Paxlovid for the treatment of COVID-19 patients with severe chronic kidney disease.
A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD)...
Renal InsufficiencyChronic1 moreThe purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC), as adjunct to ACEi/ARB therapy (lisinopril or valsartan), on slowing CKD progression (assessed as the reduction in participant's glomerular filtration rate [eGFR] decline over time) in participants with hyperkalaemia or at high risk of hyperkalaemia.
A Study of Belzutifan (MK-6482) in Participants With Renal Impairment (MK-6482-021)
End Stage Renal DiseaseRenal ImpairmentThe primary purpose of this study is to compare the plasma pharmacokinetics (PK) of belzutifan (MK-6482) following a single oral 120 mg dose in participants with end stage renal disease (ESRD) before and after hemodialysis (HD) to each other and also to that of healthy matched control participants. This study will also evaluate the safety and tolerability of a single oral 120 mg dose of belzutifan in participants with ESRD and the extent of belzutifan removed by HD.
Symbiotics and Systemic Inflammation in Chronic Kidney Disease
Chronic Renal FailureDiabete Type 21 moreMain objective: To assess the effectiveness of treatment with symbiotics on the chronic systemic inflammation observed in chronic renal failure 4 months after the start of treatment.
The "Hypotension Prediction Index" in Patients Undergoing Lung Surgery
HypotensionHemodynamic Instability3 moreThe "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. The HPI displays the probability of an occurring hypotension. The software was established with the help of 20.000 analyzed patient events. If the upper limit of the HPI is reached, the software is alarming the treating physician 8. At the university hospital of Giessen HPI analyses are used in the daily clinical routine as well as for scientific purposes. Preliminary data of the HPI-I-Trial ("Influence of the Hypotension Prediction Index on the number and duration of intraoperative hypotension in primary hip-endoprothetic replacement", University Hospital of Giessen) included patients, which underwent hip-endoprothetic replacement surgery and revealed that the use of HPI with a goal directed therapy (GDT) protocol compared to standard care significantly reduced the incidence and duration of intraoperative hypotension. Therefore HPI with GDT might reduce the incidence of hypotension related complications in a sicker patient cohort. The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Prediction Index compared to standard care can reduce the incidence of intraoperative hypotension in patients under single lung ventilation.
Safety of Short Hydration Method for Cisplatin Administration Compared With Conventional Hydration...
Renal InsufficiencyCis-Platinum NephropathyThe aim of the study is to evaluate safety of short hydration with cisplatin administration. The main outcome is renal dysfunction following cisplatin use with short hydration protocol. Another group of patients received conventional hydration is the historical control for comparison (Randomized phase II design with a reference standard treatment control arm)
A Study to Evaluate the Pharmacokinetics of HSK21542 in Subjects With Renal Impairment
Renal ImpairmentThis is an open-label, single-dose study to evaluate the pharmacokinetics and safety of HSK21542 in subjects with mild, moderate and severe renal impairment compared to the matched control subjects with normal renal function.