Comparative effectiveness of an individualized model of hemodialysis vs conventional hemodialysis: a study protocol for a multicenter randomized controlled trial (the TwoPlus trial).

BACKGROUND: Most patients starting chronic in-center hemodialysis (HD) receive conventional hemodialysis (CHD) with three sessions per week targeting specific biochemical clearance. Observational studies suggest that patients with residual kidney function can safely be treated with incremental prescriptions of HD, starting with less frequent sessions and later adjusting to thrice-weekly HD. This trial aims to show objectively that clinically matched incremental HD (CMIHD) is non-inferior to CHD in eligible patients. METHODS: An unblinded, parallel-group, randomized controlled trial will be conducted across diverse healthcare systems and dialysis organizations in the USA. Adult patients initiating chronic hemodialysis (HD) at participating centers will be screened. Eligibility criteria include receipt of fewer than 18 treatments of HD and residual kidney function defined as kidney urea clearance ≥3.5 mL/min/1.73 m2 and urine output ≥500 mL/24 h. The 1:1 randomization, stratified by site and dialysis vascular access type, assigns patients to either CMIHD (intervention group) or CHD (control group). The CMIHD group will be treated with twice-weekly HD and adjuvant pharmacologic therapy (i.e., oral loop diuretics, sodium bicarbonate, and potassium binders). The CHD group will receive thrice-weekly HD according to usual care. Throughout the study, patients undergo timed urine collection and fill out questionnaires. CMIHD will progress to thrice-weekly HD based on clinical manifestations or changes in residual kidney function. Caregivers of enrolled patients are invited to complete semi-annual questionnaires. The primary outcome is a composite of patients' all-cause death, hospitalizations, or emergency department visits at 2 years. Secondary outcomes include patient- and caregiver-reported outcomes. We aim to enroll 350 patients, which provides ≥85% power to detect an incidence rate ratio (IRR) of 0.9 between CMIHD and CHD with an IRR non-inferiority of 1.20 (α = 0.025, one-tailed test, 20% dropout rate, average of 2.06 years of HD per patient participant), and 150 caregiver participants (of enrolled patients). DISCUSSION: Our proposal challenges the status quo of HD care delivery. Our overarching hypothesis posits that CMIHD is non-inferior to CHD. If successful, the results will positively impact one of the highest-burdened patient populations and their caregivers. TRIAL REGISTRATION: Clinicaltrials.gov NCT05828823. Registered on 25 April 2023.

Performance and Interpretation of Sonography in the Practice of Nephrology: Core Curriculum 2024.

Ultrasonography is increasingly being performed by clinicians at the point of care, and nephrologists are no exception. This Core Curriculum illustrates how ultrasonography can be incorporated into clinical decision making across the spectrum of kidney disease to optimize the care nephrologists provide to patients. Sonography is valuable in outpatient and inpatient settings for the diagnosis and management of acute and chronic kidney disease, evaluation of cystic disease, urinary obstruction, pain, hematuria, proteinuria, assessment of volume status, and in providing guidance for kidney biopsy. As kidney disease advances, ultrasound is useful in the placement and maintenance of temporary and permanent access for dialysis. After kidney transplantation, ultrasonography is critical for evaluation of allograft dysfunction and for biopsies. Sonography skills expedite patient care and enhance the practice of nephrology and are relatively easily acquired with training. It is our hope that this curriculum will encourage nephrologists to learn and apply this valuable skill.

Effectiveness of ultrasound-guided cannulation of AVF on infiltration rates: A single center quality improvement study.

Though ultrasonography is increasingly used throughout the spectrum of hemodialysis access, its role in outpatient dialysis units in the United States has been limited so far. This may, in part, be due to limited ultrasound exposure, knowledge and training of dialysis staff. We implemented a quality improvement initiative in our dialysis units to expand the use of ultrasound by our frontline dialysis staff to prospectively evaluate newly placed AVF and guide cannulation. This manuscript describes our experience and the impact of our protocol on infiltration rates in our outpatient HD units.

Hemodialysis Arteriovenous Access Cosmesis Scale (AVACS): A new measure for vascular access.

RATIONALE AND OBJECTIVE: This study aimed to develop a cosmesis scale to evaluate the cosmetic appearance of hemodialysis (HD) arteriovenous (AV) accesses from the perspective of the patient and clinician, which could be incorporated into clinical trials. STUDY DESIGN: Using a modified Delphi process, two AV access cosmesis scale (AVACS) components were developed in a four-round Delphi panel consisting of two surveys and two consensus meetings with two rounds of patient consultation. SETTING AND PARTICIPANTS: The Delphi panel consisted of 15 voting members including five interventional or general nephrologists, five vascular surgeons, three interventional radiologists, and two vascular access nurse coordinators. Four patients experienced with vascular access were involved in patient question development. ANALYTICAL APPROACH: For a component to be included in the AVACS, it had to meet the prespecified panel consensus agreement of ⩾70%. RESULTS: The clinician component of the AVACS includes nine questions on the following AV access features: scarring, skin discoloration, aneurysm/pseudoaneurysms and megafistula appearance. The patient component includes six questions about future vascular access decisions, interference with work or leisure activities, clothing choices, self-consciousness or attractiveness, emotional impact, and overall appearance. LIMITATIONS: Delphi panel methods are subjective by design, but with expert clinical opinion are used to develop classification systems and outcome measures. The developed scale requires further validation testing but is available for clinical trial use. CONCLUSIONS: While safety and efficacy are the primary concerns when evaluating AV access for HD, cosmesis is an important component of the ESKD patient experience. The AVACS has been designed to assess this important domain; it can be used to facilitate patient care and education about vascular access choice and maintenance. AVACS can also be used to inform future research on developing new techniques for AV access creation and maintenance, particularly as relates to AV access cosmesis.

Point-of-care ultrasonography in nephrology comes of age.

The physical exam is changing. Many have argued that the physical exam of the 21st century should include point-of-care ultrasound (POCUS). POCUS is being taught in medical schools and has been endorsed by the major professional societies of internal medicine. In this review we describe the trend toward using POCUS in medicine and describe where the practicing nephrologist fits in. We discuss what a nephrologist's POCUS exam should entail and we give special attention to what nephrologists can gain from learning POCUS. We suggest a 'nephro-centric' approach that includes not only ultrasound of the kidney and bladder, but of the heart, lungs and vascular access. We conclude by reviewing some of the sparse data available to guide training initiatives and give suggested next steps for advancing POCUS in nephrology.

Clinical Aspects of Dialysis Interventions: Physical and Sonographic Findings.

Physical examination (PE) of arteriovenous access remains of high clinical value and continues to be recommended by leading societies and guidelines. PE is easy to learn and perform. Once learned, examiners can provide a comprehensive arteriovenous (AV) access examination in 20 to 30 seconds. Therefore, we continue to advocate that AV access PE should be part of the training for all dialysis care providers. Similarly, ultrasound can provide important AV access evaluation and provide key information. It is relatively cheap and can be readily available at the bed side. Additionally, it is well accepted by patients, as it is not expected to be associated with pain or discomfort during the examination. We present in this review the key components of PE, signs and symptoms of AV access dysfunction, and the role of ultrasound in AV access evaluation as a complementary tool to PE.

Lung Ultrasound: A "Biomarker" for Fluid Overload?

Fluid overload is associated with poor outcomes in patients with acute kidney injury as well as end-stage kidney disease. Lung ultrasound (LUS) has been used in many different settings and specialties including the emergency department, intensive care unit, trauma, cardiology, and nephrology. Although LUS has been a valuable tool in assessing pulmonary congestion, LUS findings may not always be pathognomonic for pulmonary congestion. Furthermore, the feasibility of doing an extensive LUS examination as has been done in research studies may be hard to implement within the clinical setting. This review will go over the use of LUS to evaluate for fluid overload, compare LUS with other markers of fluid overload, review limitations of LUS, and suggest potential future directions in the use of LUS in nephrology.

Ultrasound-based simulation for cannulation in outpatient hemodialysis units: An educational protocol.

Portable ultrasounds are often referred to as the "new stethoscope." Their portability and affordability have led to improved diagnostic capabilities at the point of care in virtually every field of medicine, and hemodialysis access is no exception. However, though ultrasonography is increasingly used throughout the spectrum of hemodialysis access, its role in outpatient dialysis units in the United States has been limited so far. This may, in part, be due to limited ultrasound exposure, knowledge, and training of dialysis staff. This article details an educational protocol including hands-on simulation for training dialysis technicians and nurses in ultrasound-guided cannulation techniques.

Implementation of an Electronic Catheter Checklist in Outpatient Hemodialysis Facilities: Results of a Pilot Quality Improvement Project.

Background: Performing catheter-care observations in outpatient hemodialysis facilities are one of the CDC's core interventions, which have been proven to reduce bloodstream infections. However, staff have many competing responsibilities. Efforts to increase and streamline the process of performing observations are needed. We developed an electronic catheter checklist, formatted for easy access with a mobile device, and conducted a pilot project to determine the feasibility of implementing it in outpatient dialysis facilities. Methods: The tool contained the following content: (1) patient education videos; (2) catheter-care checklists (connection, disconnection, and exit-site care); (3) prepilot and postpilot surveys; and (4) a pilot implementation guide. Participating hemodialysis facilities performed catheter-care observations on either a weekly or monthly schedule and provided feedback on implementation of the tool. Results: The pilot data were collected from January 6 through March 12, 2020, at seven participating facilities. A total of 954 individual observations were performed. The catheter-connection, disconnection, and exit-site steps were performed correctly for most individual steps; however, areas for improvement were (1) allowing for appropriate antiseptic dry time, (2) avoiding contact after antisepsis, and (3) applying antibiotic ointment to the exit site. Postpilot feedback from staff was mostly favorable. Use of the electronic checklists facilitated patient engagement with staff and was preferred over paper checklists, because data are easily downloaded and available for use in facility Quality Assurance and Performance Improvement (QAPI) meetings. The educational video content was a unique learning opportunity for both patients and staff. Conclusions: Converting the CDC's existing catheter checklists to electronic forms reduced paperwork and improved the ease of collating data for use during QAPI meetings. An additional benefit was the educational content provided on the tablet, which was readily available for viewing by patients and staff while in the hemodialysis facility.

Interventional Nephrology: Opportunities and Challenges.

The nephrologist has a pivotal role as the leader of multidisciplinary teams to optimize vascular access care of the patient on dialysis and to promote multidisciplinary collaboration in research, training, and education. The continued success of interventional nephrology as an independent discipline depends on harnessing these efforts to advance knowledge and encourage innovation. A comprehensive curriculum that encompasses research from bench to bedside coupled with standardized clinical training protocols are fundamental to this expansion. As we find ourselves on the threshold of a much-awaited revolution in nephrology, there is great opportunity but also formidable challenges in the field - it is up to us to work together to realize the enormous potential of our discipline.

The Nephrologist as an Ultrasonographer.

Ultrasonography is increasingly being used in the practice of nephrology, whether it is for diagnosis or management of acute or chronic kidney dysfunction, until progression to end-stage kidney disease, including preoperative assessment, access placement, and diagnosis and management of dysfunctional hemodialysis access. Point-of-care ultrasounds are also being used by nephrologists to help manage volume status, especially in patients admitted to the intensive care units, and more recently, for guiding fluid removal in the outpatient dialysis units. Fundamental knowledge of sonography has become invaluable to the nephrologist, and performance and interpretation of ultrasound has now become an essential tool for practicing nephrologists to provide patient-centered care, maximize efficiency, and minimize fragmentation of care. This review will address the growing role of ultrasonography in the management of a patient with CKD from the point of initial contact with the nephrologist throughout the spectrum of kidney disease and its consequences.

Buttonhole Cannulation of Arteriovenous Fistulas in the United States.

The cannulation technique of a hemodialysis vascular access has remained controversial with differing viewpoints. The quality of dialysis, overall patient safety, and individual dialysis experience often dictate the type of cannulation technique used in clinical practice. The three commonly used techniques to access a hemodialysis vascular access are the rope ladder, area, and buttonhole. Although the buttonhole technique has been around since the mid-1970s, the dialysis community remains divided on its suitability for routine use to provide maintenance hemodialysis therapy. The proponents of this technique value the ease of cannulation with less pain and discomfort whereas the opponents highlight the increased risk of infection. The actual clinical evidence from the United States is limited and remains inconclusive. The current review provides an overview of the available experience from the United States, highlighting the correct technique of creating a buttonhole, summarizing the current evidence, and recommending a need for larger randomized controlled studies in both in-center and home hemodialysis populations.

Ultrasound in dialysis access: Opportunities and challenges.

Sonography is increasingly being used by nephrologists and the field of dialysis access is no exception. Advances in technology have allowed the addition of this universally available, portable, non-invasive tool to the nephrologist's armamentarium, which provides information on both morphology and physiology without the need for contrast or radiation. Ultrasound may be used across the spectrum of dialysis access, including central venous catheter placements, vascular mapping, regional anesthesia, creation, maintenance and assessment of hemodialysis access as well as assessment of the abdominal wall and peritoneal dialysis catheter placements. However, the lack of exposure in most training programs limits incorporation of routine use of ultrasounds in nephrology practice. As our specialty embarks on the ultrasound revolution, a two-pronged approach is essential to provide ample training opportunities while ensuring establishment of basic standards for training and competency.

Patient selection, education, and cannulation of percutaneous arteriovenous fistulae: An ASDIN White Paper.

End-stage kidney disease patients who are candidates for surgical arteriovenous fistula creation commonly experience obstacles to a functional surgical arteriovenous fistula, including protracted wait time for creation, poor maturation, and surgical arteriovenous fistula dysfunction that can result in significant patient morbidity. The recent approval of two endovascular devices designed to create a percutaneous arteriovenous fistula enables arteriovenous fistula creation to be placed in the hands of interventionalists, thereby increasing the number of arteriovenous fistula providers, reducing wait times, and allowing the patient to avoid surgery. Moreover, current studies demonstrate that patients with percutaneous arteriovenous fistula experience improved time to arteriovenous fistula maturation. Yet, in order to realize the potential advantages of percutaneous arteriovenous fistula creation within our hemodialysis patient population, it is critical to select appropriate patients, ensure adequate patient and dialysis unit education, and provide sufficient instruction in percutaneous arteriovenous fistula cannulation and monitoring. In this White Paper by the American Society of Diagnostic and Interventional Nephrology, experts in interventional nephrology, surgery, and interventional radiology convened and provide recommendations on the aforementioned elements that are fundamental to a functional percutaneous arteriovenous fistula.

Point-of-care ultrasound in the practice of nephrology.

Sonography is increasingly being performed by clinicians and has applications throughout the spectrum of nephrology, including acute and chronic renal failure, urinary obstruction, cystic disease, pain, hematuria, transplantation, kidney biopsy, temporary and permanent vascular access, and assessment of fluid status. The skill is relatively easily acquired, expedites patient care, and enhances the practice of nephrology. However, the lack of exposure in most training programs remains a major obstacle.