Renal Failure

This research evaluates how well furosemide alone compares to furosemide combined with albumin in critically ill adults who have fluid overload. The study aims to find out if adding albumin improves urine output and kidney function markers compared to using furosemide by itself. Key measurements include urine output two hours after treatment, kidney blood flow indicators, and various biochemical tests. Participants are randomly assigned to receive either furosemide at 1 mg per kg of body weight intravenously over 30 minutes with a placebo, or the same dose of furosemide together with 50 grams of 25% albumin infused over 30 minutes. The study uses bedside ultrasound to assess fluid overload signs and monitors blood pressure, electrolytes, and kidney filtration rates during the trial. During the study, participants undergo urine output measurement at two hours and blood tests to track changes in kidney function and electrolyte levels up to 24 hours after treatment. Ultrasound evaluations assess vein size and congestion at baseline and after two hours. Researchers monitor safety and response to treatment while collecting data on urine volume and kidney health markers to understand the impact of adding albumin to furosemide therapy.

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.

The GENESIS clinical study aims to map HLA genetic variation in the Greek population and evaluate possible correlations with selected underlying diseases. It is a multicenter, prospective, non-interventional clinical study targeting 12,000 subjects over an anticipated duration of 36 months, with the goal of creating a pilot HLA map for medical research and possible clinical applications. Each subject will complete one visit at a participating site and provide demographic information, including date of birth, gender, race, ancestry, height, and weight, as well as information about smoking or vaping, alcohol consumption, arterial blood pressure, diagnosed diseases, and current treatments. Recent clinical laboratory results from up to 12 months before sample collection may also be collected when available, including blood count, metabolic, liver enzyme, and biochemical parameters. Two buccal swabs will be collected from each subject for DNA extraction and HLA genotyping analysis. Selected DNA samples will also undergo low-pass whole genome sequencing to further investigate associations between the HLA region and autoimmune diseases. After the analysis is completed, an individualized ancestry report will be securely available to study subjects if they elect to access it.

Researchers are studying how the drug MK-2828 behaves in the body over time, focusing on people with different levels of kidney disease compared to healthy individuals. This Phase 1 trial aims to understand the drugs pharmacokinetics, or how it is absorbed, distributed, metabolized, and eliminated in people with severe renal impairment, end-stage renal disease ESRD on hemodialysis, and healthy controls. Participants are divided into three groups based on kidney function. Those with severe renal impairment receive a single oral dose of MK-2828 on Day 1. Participants with ESRD on hemodialysis receive a single dose on Day 1 during two separate periods, with at least a 14-day break between doses. Healthy participants with normal kidney function also receive a single dose on Day 1. This open-label study does not involve randomization or blinding. During the trial, participants undergo blood sampling before dosing and at several time points up to 192 hours after receiving MK-2828 to measure drug concentrations and pharmacokinetic parameters. For those on hemodialysis, additional measurements related to dialysis clearance are collected up to 6 days. Safety is monitored by tracking adverse events for about two weeks. Participation lasts a few days depending on the dosing schedule and required sampling times.

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 Utahs 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.