Integrating a Research Protocol into a Health Care Setting.

Initiating a research protocol into any health care setting requires planning to ensure the research is conducted safely and efficiently, and will yield accurate data. An understanding of basic research principles is essential in this process. One agency that provides Good Clinical Practice guidelines for research is the International Council for Harmonization. This agency mandates Insti tutional Review Board (IRB) oversight for all studies that involve human subjects. The IRB ensures the research design and protocol protect the rights, welfare, and safety of human subjects, as well as appropriate data collection. Once IRB approval is obtained, protocol integration can begin, utilizing the planning described in this article.

Institutional Usage of Ferric Pyrophosphate Citrate (FPC) Delivered Via Dialysate in Reducing Erythropoiesis Stimulating Agents (ESAs) and IV Iron Cost.

Dialysis patients are often iron deficient due to a multiple factors. Ferric pyrophosphate citrate is a complex iron salt that can be given via dialysate allowing maintenance of hemoglobin (Hgb) concentration and iron balance while reducing the need for IV iron. The purpose of this study is to perform a cost evaluation of FPC and the effect it has on lowering the dose/use of ESAs and IV iron therapy. This study reviewed the same 100 hemodialysis patient's charts before and after the use of FPC. The data points that were collected and analyzed are as follows: hemoglobin, ferritin levels, average weekly ESA dosing, and IV iron replacement therapy dose. Out of 100 patients, there was no statistical difference in the average hemoglobin, ferritin, and iron saturation levels observed in the patients before and after FPC use. The average weekly dose of darbepoetin alfa per patient was 52.74 µg before the FPC group compared to 39.27 µg in the post FPC group (P < .0001). The total dose of ferric gluconate per patient was 3290.01 mg in the before FPC group and 585.60 mg in the post FPC group (P < .0001). The average total iron sucrose dose per patient in the before FPC group was 3097.92 mg versus 1216.67 mg in the post FPC group (P < .1563). When comparing FPC's cost and implementation into both of our outpatient dialysis centers, this yielded a net savings of $296 751.49.

Navigating the Institutional Review Board Process.

Participating in a research project can be a very rewarding activity. Yet prior to undertaking any aspect of a research project that involves human participants, the principal investigator must submit their project to and gain approval from an Institutional Review Board (IRB). This article in the "Exploring the Evidence: Focusing on the Fundamentals" series provides nephrology nurses with basic information related to the IRB process, as well as steps to follow in the preparation and submission of a research project for IRB approval.

Managing Research in a Chaotic Environment.

As we reflect back to the time before the pandemic, we can take a breath and identify all of the amazing obstacles that were overcome through teamwork. This article reflects the challenges that New York University Langone Hospital- Long Island encountered trying to overcome the clinical challenges of treating patients with COVID-19 while integrating research into a chaotic and ever-changing environment. Early on, it became evident that acute kidney failure was a major complication of this virus, and nephrology nurses played an integral role in managing this outcome. Science was the shining light that gave hope through the research, which was conducted as a team effort throughout the organization.

Mental Health and Health-Related Quality of Life Among Nephrology Nurses: A Survey-Based Cross-Sectional Study.

Nephrology nurses face health and wellness challenges due to significant work-related stressors. This survey, conducted online between July 24 and August 17, 2020, assessed the psychological well-being of nephrology nurses in the United States during the COVID-19 pandemic (n = 393). Respondents reported feeling burned out from work (62%), symptoms of anxiety (47% with Generalized Anxiety Disorder-7 [GAD-7] scores ≥ 5), and major depressive episodes (16% with Patient Health Questionnaire-2 [PHQ-2] scores ≥ 3). Fifty-six percent (56%) of survey respondents reported caring for COVID-19 patients, and 62% were somewhat or very worried about COVID-19. Factors, including high workload, age, race, and the COVID-19 pandemic, may partially explain the high proportion of nephrology nurses who reported symptoms of burnout, anxiety, and depression.

COVID-19 Antibodies and Outcomes among Outpatient Maintenance Hemodialysis Patients.

Background: Patients on maintenance hemodialysis are particularly vulnerable to infection and hospitalization from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Due to immunocompromised patients and the clustering that occurs in outpatient dialysis units, the seroprevalence of COVID-19 antibodies in this population is unknown and has significant implications for public health. Also, little is known about their risk factors for hospitalization. Methods: Three outpatient maintenance hemodialysis units affiliated with a major teaching hospital in the New York area were studied. We determined rates of SARS-CoV-2 positivity via nasopharyngeal, real-time, reverse-transcriptase PCR (RT-PCR); SARS-CoV-2 IgG seropositivity; hospitalization; and mortality. Results: Of 367 patients, 28% had either SARS-CoV-2 seropositivity or PCR positivity. Prevalence across the three respective units was 7%, 32%, and 70%. Those who were either antibody or PCR positive were significantly younger (65 versus 69 years, P=0.05), and had a higher prevalence of Black race (43% versus 30%, P=0.001) and Hispanic ethnicity (32% versus 12%, P<0.001) compared with those who tested negative. Higher positivity rates were also observed among those who took taxis and ambulettes to and from dialysis, compared with those who used personal transportation. Antibodies were detected in all of the patients with a positive PCR result who underwent serologic testing. Of those that were seropositive, 32% were asymptomatic. The hospitalization rate on the basis of either antibody or PCR positivity was 35%, with a hospital mortality rate of 33%. Aside from COPD, no other variables were more prevalent in patients who were hospitalized. Conclusions: We observed significant differences in rates of COVID-19 infection within three outpatient dialysis units, with universal seroconversion. Among patients with ESKD, rates of asymptomatic infection appear to be high, as do hospitalization and mortality rates.

The Huddle: It's Not Just for Football Anymore.

Huddles are a wonderful team-building tool to enhance team function and efficiency. The Institute of Medicine (2011) report, The Future of Nursing--Leading Change, Advancing Health, identifies the need for collaborative healthcare teams. This is based on 14 years of research and evidence. Creating a team culture is identified as being essential to delivering high-quality patient care. Huddles are easy to complete and don't cost anything but a few minutes that are well worth their while! It's not often we get an opportunity to do so much with so little. So, 1, 2, 3, Hut; let's all go Huddle!

The effect of hemodialysis ultrafiltration on changes in whole blood viscosity.

Increased whole blood viscosity (WBV) can be injurious to the vascular endothelium and increase the risk of atherothrombotic events. This study examined the effect of hemodialysis ultrafiltration (UF) on WBV, with a focus on high vs. low-volume UF patients. In stable hemodialysis patients, blood was drawn for hematocrit (Hct) and WBV at the start, midpoint, and at the end of dialysis. For analysis, patients were divided into high UF (≥2700 mL) or low UF (<2700 mL) groups. A total of 59 patients completed the study. Mean Hct increased during dialysis in both groups. The intradialytic increase in Hct was significantly greater in the high vs. the low UF group (3.2% vs. 1.28%, P = 0.01), with a significantly higher end-dialysis Hct in the high UF group (40.5% vs. 38%, P = 0.02). At the end of dialysis, both high shear rate WBV (P < 0.01) and low shear rate WBV (P < 0.01) were significantly higher in the high UF compared with the low UF group. There was an approximately two-fold greater increase in high shear rate (P < 0.01) and low shear rate (P = 0.01) WBV during dialysis in high vs. low UF groups. The increase in high shear rate WBV during dialysis was significantly correlated with an increase in Hct (R(2) = 0.63, P < 0.01). We found that hemodialysis UF causes a surge in WBV. The surge was of greater magnitude in high than in low UF patients.

Erythropoiesis-stimulating agents for the management of anemia of chronic kidney disease: past advancements and current innovations.

Over the last century, remarkable advances have been made in the care of patients with end stage renal disease (ESRD), resulting in improved prognosis. However, for decades after the advent of dialysis, anemia-associated symptoms continued to adversely affect patients' daily lives. The identification, isolation, and eventual cloning of erythropoietin and its receptor led to development of erythropoiesis stimulating agents, revolutionizing anemia management. Continued advancements have paved the way for the discovery of novel erythropoiesis stimulating agents with enhanced properties. This article charts the history of anemia management in patients with ESRD, including the discovery of erythropoietin, and briefly reviews the development, mechanism of action, and select attributes of erythropoiesis-stimulating agents.

A practical review of the kidney dialysis outcomes quality initiative (KDOQI) guidelines for hemodialysis catheters and their potential impact on patient care.

In North America, the creation of the arteriovenous fistula is the optimal form of access for patients on hemodialysis (HD). However, the majority of patients start HD with a hemodialysis catheter, and many continue to use a catheter 90 days after placement. Additionally, as the population of patients on HD grows older, the number of patients dependant on a catheter as their permanent mode of HD access increases. Although catheters are not the preferred choice for HD access, when they are used the proper care and treatment of these devices may decrease patient morbidity and mortality.

Oral paricalcitol in the treatment of patients with CKD and proteinuria: a randomized trial.

BACKGROUND: Vitamin D has key roles in regulating systems that could be important in the pathobiological state of proteinuria. Because of this, it could be helpful in treating patients with proteinuric renal diseases. The objective is to determine the effect of oral paricalcitol on protein excretion in patients with proteinuric chronic kidney disease. STUDY DESIGN: Double-blind randomized study. SETTING & PARTICIPANTS: 61 patients with estimated glomerular filtration rate of 15 to 90 mL/min/1.73 m(2) and protein excretion greater than 400 mg/24 h. INTERVENTION: Randomization to 6 months of treatment with paricalcitol, 1 mug/d, or placebo. OUTCOMES & MEASUREMENTS: The predefined primary end point was to compare change in mean spot urinary protein-creatinine ratio between the baseline measurement and the last study evaluation (6 months in study completers) between the 2 groups. Every 4 weeks, there was measurement of serum intact parathyroid hormone, serum calcium, serum phosphorus, serum creatinine, and urine spot protein and creatinine. RESULTS: At baseline, mean urinary protein-creatinine ratios were 2.6 and 2.8 g/g in the placebo and paricalcitol groups, respectively. At final evaluation, mean ratios were 2.7 and 2.3, respectively. Changes in protein excretion from baseline to last evaluation were +2.9% for controls and -17.6% for the paricalcitol group (P = 0.04). A 10% decrease in proteinuria occurred in controls (7 of 27; 25.9%) and the paricalcitol group (16 of 28; 57.1%; P = 0.03). LIMITATIONS: The relatively small sample size limits the extent to which results should be generalized. CONCLUSIONS: Paricalcitol resulted in a significant reduction in protein excretion in patients with proteinuric renal disease.

Guarding against hidden hemolysis during dialysis: an overview.

The paper discussed during spring 2007 was a case study report entitled "Hemolysis: A Hidden Danger" published in the Nephrology Nursing Journal. The authors, Elisabeth Harman and Paula Dutka, agreed to follow the discussion and respond to points raised. Sixteen contributors from ten different countries provided insights into the potential causes, symptoms and effects of both acute and hidden hemolysis during dialysis, as well as discussing some of the safety systems that can be used to try and minimise occurrences. The use of blood volume monitoring as a potential method of 'seeing' hidden hemolysis was explored as well as some reporting mechanisms and organisational safeguards that are used to manage the risks.

Hidden hemolysis.

The exact cause of this case of hemolysis has not been definitively determined, although evidence has pointed to a possible defect in the dialysis blood lines, which remains the only plausible etiology. However, we must always keep patient safety at the forefront so that the cause can be identified. The majority of our dialysis nursing staff has had extensive hemodialysis experience with the current equipment. None of us had ever experienced hemolysis before. When the etiology remained elusive, we kept struggling with the thought of "Why after all these years?" We must never lose sight of the fact that day in and day out we perform thousands of technologically complex procedures that have many potential complications. Since this incident, we have heard of other similar cases past and present. We reached out to a company that assists with medical investigations to determine if this was being experienced in other facilities. Since then, other facilities have contacted us with very similar stories. Why are we seeing more of this now? Do higher hemoglobins in our patients play a role in this? Are proper quality controls followed by manufacturers? There are many questions that need to be answered and research to be done. Lastly, as medical professionals, we must network and share the information we have been able to gather. This is about patient safety, not blame.

Hemolysis: a hidden danger.

Hemolysis is something that occurs to a small degree with every dialysis treatment. As we monitor our patients and the equipment we use, we hope that we have looked at everything and that our patients will be safe. We were extremely fortunate that we did not have a mortality related to this event. All of the hospitalized patients recovered and HP went on to receive her kidney transplant and is doing well. CG came back to dialyze in our unit after his physician was satisfied that our problem had been solved. In retrospect, we did not realize that we had an instrument in use that picked up the hemolysis long before we did. Our blood volume monitors showed us the increase in blood volume as the cells were lysed and vascular volume increased as the intracellular fluids were released. The concurrent rise in BP with these patients was also indicative of increased vascular volume. The blood volume monitor also showed the drop in hematocrit as red cells were lysed. We are now more experienced in interpreting these parameters and we are grateful to have this monitor on all of our patients and to have a new parameter to watch for to help forestall any further problems. Our patients' symptoms were baffling at the time because there were no overt signs of hemolysis. There was no "cherry pop" or brown colored blood in the lines or dialyzers which are what we have been taught to look for. Patients #1 and #3 essentially had no symptoms till the next day. Patient #2 exhibited nausea and some mild abdominal pain, which was also not new for him with his diabetic gastroparesis. Our nursing staff was very "gun shy" following this episode and some staff members seriously considered a change in profession. Fortunately they did not and opted to stay. It was brought home to all that dialysis, though it may seem to be a routine procedure, is inherently risky. Diligence and careful monitoring of all of our patients during their runs needs to be our utmost priority. Hemolysis to this degree is fortunately rare and we are grateful to have had an education with a positive outcome for all concerned.

A randomized controlled trial of N-acetylcysteine to prevent contrast nephropathy in cardiac angiography.

BACKGROUND: Contrast nephropathy (CN) is a common cause of renal dysfunction after cardiac angiography. Recently, N-acetylcysteine (NAC) has been found to reduce the risk of CN after CT imaging with contrast enhancement. The purpose of the current study was to evaluate the efficacy of NAC for the prevention of CN in the setting of cardiac angiography. METHODS: Eligible patients were those undergoing cardiac angiography with serum creatinine>1.7 mg/dL. Patients were randomized to one of two groups: Group 1, IV hydration and NAC, 1200 mg one hour before angiography, and a second dose 3 hours after; Group 2, IV hydration and placebo. CN was defined as an increase of 0.5 mg/dL in serum creatinine. RESULTS: Seventy-nine patients completed the study. There were no significant differences between the groups in baseline characteristics, duration of angiography, mean volume of dye infused or mean IV hydration. Contrast nephropathy developed in 24.0% of subjects, 26.3% NAC, and 22.0% placebo (P = NS). Among subjects with diabetes mellitus, there was no significant difference in the rate of CN between the groups (42.1% NAC, 27.8% placebo; P = 0.09). The independent predictors of CN risk were diabetes mellitus and preexisting chronic renal insufficiency. CONCLUSIONS: NAC was not effective for the prevention of CN after cardiac angiography.