Renal Failure

Researchers are evaluating the effects of furosemide alone compared to furosemide combined with albumin in adult critically ill patients with fluid overload. The study aims to find out if adding albumin improves urine output and kidney function. The primary focus includes measuring urine output at 2 hours and examining changes in kidney blood flow markers and biochemical tests. Secondary measures include blood pressure, electrolyte levels, and kidney resistance patterns. Participants are randomly assigned to one of two groups: one receives a single intravenous dose of furosemide at 1 mg/kg infused over 30 minutes with a placebo saline infusion, while the other receives the same dose of furosemide combined with 50 grams of 25% albumin infused over 30 minutes. This double-blind trial ensures both groups are treated under similar controlled conditions to compare the treatments effectively. During the study, urine output is measured at 2 hours after treatment administration. Researchers also use bedside ultrasound to assess fluid overload and venous congestion, while monitoring blood pressure, electrolyte changes, and kidney function through blood and urine tests up to 24 hours. The study helps determine whether albumin enhances diuretic response and kidney health in this patient group. Participation lasts through these initial assessments and monitoring periods.

Researchers are investigating why some men with Benign Prostatic Hyperplasia (BPH), a common condition causing urinary problems due to prostate enlargement, do not respond to the typical treatment drug Finasteride. The study focuses on understanding resistance to this treatment and hopes to use noninvasive methods like MRI to detect prostate inflammation and predict which patients will not benefit from Finasteride, allowing for alternative treatments in the future. Men eligible for the study will receive Finasteride as standard care for BPH symptoms, particularly those with moderate urinary symptoms and a prostate size over 40cc. Participants will undergo prostate MRIs and biopsies, along with blood and urine tests, before starting treatment. They will be monitored every six months with symptom assessments and have follow-up MRIs at three years to track changes in prostate size and inflammation, while tissue samples will be analyzed for gene expression and hormonal levels. Throughout the study, participants will attend clinic visits to evaluate urinary symptoms and treatment response, with a key assessment at 12 months to measure the effect of Finasteride. Researchers will collect detailed data including MRI scans, prostate tissue analyses, and hormone tests to understand treatment resistance. The study aims to improve how BPH is managed by identifying patients unlikely to respond to current therapy, with monitoring continuing over several years to gather comprehensive information.

Researchers are conducting the GENESIS clinical study to map the HLA genomic region in the Greek population and explore its possible links with various underlying diseases. This non-interventional, multicenter study aims to provide a pilot map of genetic variation in HLA that may be useful in medical research and clinical applications related to selected diseases. The study plans to include 12,000 participants over a total duration of 36 months. Each participant will attend one visit at a participating site during which they will provide demographic data, lifestyle information such as smoking and alcohol use, blood pressure measurements, details on diagnosed diseases and treatments, and recent laboratory test results if available. Buccal swab samples will be collected from each participant to extract DNA for HLA genotyping analysis. Selected samples will undergo further whole genome sequencing to investigate associations with autoimmune diseases. Participants will receive a personalized ancestry report after analysis completion. During the study visit, data collection includes demographic and health information, as well as laboratory and clinical test results from the past year. The genetic material from buccal swabs will be stored and processed for genetic analysis. Researchers will measure allele frequency of HLA alleles in the Greek population and assess the prevalence and risk associations of selected HLA-related diseases. The study's total duration is 36 months with results available at the end of this period.

Researchers are evaluating the pharmacokinetics, or how the body processes, of one or two doses of the drug MK-2828 in people with kidney disease. The study aims to determine if the way MK-2828 behaves in individuals with certain types of kidney impairment is similar to that in healthy people. This research is a Phase 1 clinical trial focusing on participants with severe renal impairment, end-stage renal disease (ESRD), and healthy controls. Participants with severe renal impairment will receive a single oral dose of MK-2828 on Day 1. Those with ESRD on hemodialysis will receive a single dose in each of two study periods, separated by at least 14 days. Healthy participants with normal kidney function will receive a single dose on Day 1. The trial is open-label, meaning all participants and researchers know which treatment is given. During the study, participants will have blood samples collected before dosing and at various times up to 192 hours afterward to measure drug levels and related pharmacokinetic parameters. Those on hemodialysis will have additional assessments related to dialysis clearance. Safety will be monitored through tracking adverse events up to approximately 14 days. The study will continue until July 2026, with participants involved in a single-dose administration and follow-up sampling and observation.

Researchers are evaluating a communication-priming intervention called "CKD Jumpstart- Tips" aimed at improving shared decision-making between older adults with advanced chronic kidney disease (CKD) and their clinicians. This cluster-randomized controlled trial focuses on patients with CKD Stage 4 or 5, seeking to enhance communication quality, patient involvement, decisional conflict, decision regret, timing and adherence to treatment choices, and health-related quality of life. The study compares two groups: one receiving the "CKD Jumpstart- Tips" intervention and the other receiving usual care. Patients in the intervention group complete the priming tool before a target clinic visit and receive a summary sheet with communication tips and survey responses to share with their healthcare team. Clinicians also receive a priming sheet with tailored communication guidance based on patient responses. Additional educational materials on kidney failure treatment options are available as part of routine care. Participants will be assessed immediately after the target visit and followed for up to six months. Evaluations include observer-rated and patient-reported shared decision-making, quality of communication, consultation length, patient involvement, decisional conflict and regret, timing and adherence to treatment, and health-related quality of life. The study aims to measure the impact of the communication intervention on these outcomes while monitoring patient experience and treatment decisions over time.

This research aims to compare two timings of physical therapy for adults with end-stage renal disease (ESRD) who are undergoing hemodialysis. The study evaluates whether exercising during dialysis sessions or before dialysis leads to better improvements in physical function, quality of life, and laboratory measures such as hemoglobin and electrolyte levels. A total of 72 adult participants will take part in this randomized controlled trial to help determine the best approach to physical therapy in this population. Participants will be randomly assigned to one of two groups. One group will perform supervised physical therapy exercises during their dialysis sessions twice weekly for 12 weeks, while the other group will perform the same exercises before their dialysis sessions on the same schedule. Each session lasts about 30 minutes and includes warm-up, resistance training, and cool-down. Both groups will first receive standardized education about the benefits and safety of exercise before starting the intervention. Throughout the study, participants will undergo assessments including the Six-Minute Walk Test, Five Times Sit-to-Stand Test, and quality of life questionnaires at baseline, every four weeks during the 12-week intervention, and at a 6-month follow-up. Blood tests to measure hemoglobin and electrolyte levels will be done at baseline and at 4, 8, and 12 weeks. The study monitors these outcomes to evaluate the effects of exercise timing on health and well-being for individuals on hemodialysis.

Researchers are evaluating the use of Near Infrared Spectroscopy (NIRS) to predict acute kidney injury (AKI) in adult patients undergoing cardiac surgery with cardiopulmonary bypass. AKI is a common and serious complication after such surgeries, leading to increased hospital stays, costs, and mortality. This study aims to compare the effectiveness of NIRS sensors placed on the skin over the kidney versus sensors placed on the limbs for predicting AKI. The research is conducted by the University of Utah's anesthesiology department. Participants will have NIRS sensors placed on the skin over their kidney, as located by ultrasound, and on the muscles of their arm and thigh before surgery. If a patient has had a right nephrectomy, the sensor will be placed over the left kidney. Additional sensors will be placed on the forehead to measure brain oxygen levels during surgery. The study observes how well these sensor placements predict AKI from the day of surgery up to seven days afterward. During the study, participants will undergo ultrasound measurements to determine the depth of kidney and muscle tissue before sensor placement. Researchers will monitor oxygen levels in various tissues throughout surgery and track outcomes such as AKI development, ventilator times, length of hospital stay, and in-hospital mortality up to three months. Hemodynamic data including blood pressure, oxygen delivery, vasopressor use, and anemia during surgery will also be recorded. The total observation period extends from surgery through hospital discharge and follow-up for up to three months.

Researchers are comparing two drugs, cilastatin and thiosulfate, to see which better protects the kidneys in female patients undergoing debulking surgery combined with intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) using cisplatin. This phase 2, double-blind, randomized clinical trial evaluates whether cilastatin is not less effective than thiosulfate in preventing kidney damage in this setting. Participants receive either 1.5 grams of cilastatin or thiosulfate during their debulking surgery with HIPEC. The study uses a triple-blind design to prevent bias and randomly assigns patients to one of the two treatment groups. The main focus is on kidney protection during and after this specialized chemotherapy procedure, which targets tumors in the abdomen. During the study, researchers monitor patients for kidney failure within the first seven days after surgery to measure the primary outcome. Patients are assessed for overall health and eligibility before surgery, and kidney function is carefully tracked. The total participant age range is 18 to 75 years, and only females diagnosed with ovarian cancer suitable for this surgery are included. The study runs until October 2028 with ongoing monitoring and evaluation.

Researchers are evaluating the use of a high protein egg white pudding as a nutritional supplement for people with kidney failure who are on dialysis. The study aims to find out if giving this egg white pudding after dialysis is practical and whether it can improve blood protein levels, frailty, dietary intake, and other blood markers compared to a standard supplement called Ensure Plus. This trial is conducted by Seven Oaks Hospital Chronic Disease Innovation Centre. Participants will be randomly assigned to receive either the egg white protein pudding or Ensure Plus at the end of their dialysis treatments three times a week for 12 weeks. Both supplements are dietary and taken during the dialysis sessions. The study collects data during this 12-week intervention period to evaluate the effects of the two supplements. During the study, participants will be monitored for their ability to stay in the trial, adherence to the supplements, and health measures such as hand grip strength, walking speed, balance, and blood levels including serum albumin and electrolytes. These assessments occur at the end of the 12 weeks. The trial also tracks recruitment and follow-up rates to evaluate feasibility. Overall, participants are involved in regular supplement intake and health testing during dialysis over three months.

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index (MDPI) to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass (CPB). This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts: first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions; second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables; and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.