Acute Kidney Injury With Tobramycin-Impregnated Bone Cement Spacers in Prosthetic Joint Infections.

BACKGROUND: Antibiotic-impregnated bone cement spacer (ACS) with tobramycin ± vancomycin is commonly used in a 2-stage replacement of infected prosthetic joints. This procedure has been associated with development of acute kidney injury (AKI). OBJECTIVE: To determine the incidence and risk factors for AKI after implantation of tobramycin-impregnated ACS. METHODS: This prospective, observational study evaluated 50 consecutive patients who received tobramycin ACS for first-stage revision of an infected hip or knee arthroplasty from August 2011 to February 2013. AKI was defined as 50% or greater rise in serum creatinine (SCr) from baseline within the first 7 postoperative days (PODs). RESULTS: The incidence of AKI was 20%, with median onset occurring at POD 2 (interquartile range [IQR] = 1-3); patients with AKI had a longer median duration of hospital stay (16 days, IQR = 12-17, vs 10 days, IQR = 8-10; P = 0.03). Serum tobramycin concentrations were significantly higher in the AKI group, peaking on POD 1 (median 1.9 vs 0.9 µg/mL, P = 0.01). Risk factors for nephrotoxicity identified by multivariate analysis were use of bone cement premanufactured with gentamicin (OR = 8.2; 95% CI = 1.1-60; P = 0.04), administration of blood transfusions intraoperatively (OR = 32.5; 95% CI = 2.3-454.3; P = 0.01) and nonsteroidal anti-inflammatory drugs postoperatively (OR = 23.0; 95% CI = 1.3-397.7; P = 0.03). CONCLUSIONS: Tobramycin ACS is associated with a high risk of AKI. Measures to minimize AKI risk in the perioperative period include early detection through close monitoring of SCr, avoiding use of premanufactured bone cement containing gentamicin, and avoiding potential nephrotoxins within the first 72 hours postoperatively.

Comparison of Tetrasodium EDTA 4% with Sodium Citrate 4% as Line-Locking Solutions at 2 Tertiary Hemodialysis Centres.

Background: The patency of central venous catheters (CVCs) in patients undergoing hemodialysis (HD) is maintained by instilling sodium citrate 4% (SC 4%) locking solution. Alteplase, a thrombolytic agent, is administered to restore function if patency is lost. Objective: To compare SC 4% with a new line-locking solution, ethylenediaminetetraacetic acid 4% (EDTA 4%), in terms of CVC patency and alteplase use. Methods: This retrospective chart review included all HD patients who were switched from SC 4% to EDTA 4% locking solution at 2 tertiary HD centres between June and December 2021. Patients were switched to EDTA 4% if they had high usage of alteplase (receiving ≥ 2 doses of alteplase in a 2-week period). For each line-locking agent, HD pump speeds and alteplase use were analyzed over 2 consecutive 12-week periods. Mean serum calcium and ionized calcium values were recorded during each period. A cost analysis was also performed. Results: A total of 37 HD patients were switched to EDTA 4% during the study period. There was no difference in mean HD pump speed between SC 4% and EDTA 4% (307.7 vs 305.1 mL/min, p = 0.48). The number of catheter-use-days on which alteplase was required declined significantly, from 313 days with SC 4% to 94 days with EDTA 4% (p < 0.001), with an overall cost reduction of 34% ($13 183.21). The decrease in alteplase usage was primarily driven by 1 of the 2 sites. A statistically significant decrease in mean ionized calcium at site 2 (from 1.12 to 1.1 mmol/L, p = 0.037) was noted. As well, an intraluminal interaction between EDTA 4% and serum calcium caused 6 cases of low serum calcium. Conclusions: This study showed that use of EDTA 4% as a line-locking agent reduced alteplase usage in the CVCs of HD patients while maintaining adequate pump speed (i.e., ≥ 300 mL/min).

Contexte: La perméabilité des cathéters veineux centraux (CVC) chez les patients hémodialysés (HD) est maintenue en instillant une solution de verrouillage de citrate de sodium à 4 % (CS 4 %). L'alteplase, un agent thrombolytique, est administré pour rétablir la fonction en cas de perte de perméabilité. Objectif: Comparer la solution de CS 4 % et une nouvelle solution de verrouillage, l'acide éthylènediaminetétraacétique 4 % (EDTA 4 %), en termes de perméabilité du CVC et d'utilisation de l'alteplase. Méthodes: Cet examen rétrospectif des dossiers a été réalisé pour tous les patients HD qui sont passés de la solution de verrouillage de CS 4 % à la solution d'EDTA 4 % dans 2 centres d'hémodialyse tertiaires au cours de la période de juin à décembre 2021. Les patients sont passés à l'EDTA 4 % en cas d'utilisation élevée de l'alteplase (≥ 2 doses d'alteplase reçues sur une période de 2 semaines). Pour chaque agent de verrouillage, les vitesses de la pompe d'hémodialyse et l'utilisation de l'alteplase ont été analysées sur 2 périodes consécutives de 12 semaines. Les valeurs moyennes de calcium sérique et de calcium ionisé ont été enregistrées au cours de chaque période. Une analyse des coûts a également été réalisée. Résultats: Au total, 37 patients HD sont passés à l'EDTA 4 % au cours de la période de l'étude. Aucune différence dans la vitesse moyenne de la pompe d'hémodialyse n'a été constatée en cas d'utilisation de la solution de CS 4 % ou d'EDTA 4 % (307,7 c. 305,1 mL/min, p = 0,48). Le nombre de jours d'utilisation du cathéter qui ont nécessité l'utilisation de l'alteplase a diminué de manière significative, passant de 313 jours avec la solution de CS 4 % à 94 jours avec l'EDTA 4 % (p < 0,001); la réduction globale des coûts se montait à 34 % (économies de 13 183,21 $). L'utilisation moins importante de l'alteplase était principalement due à 1 des 2 sites. Une diminution significative du calcium ionisé moyen (1,12 c. 1,1 mmol/L, p = 0,037) a été observée au deuxième site. De plus, une interaction intraluminale entre l'EDTA 4 % et le calcium sérique a provoqué 6 cas d'hypocalcémie. Conclusions: Cette étude a montré que l'utilisation de l'EDTA 4 % comme agent de verrouillage réduisait l'utilisation de l'alteplase dans les CVC des patients HD tout en maintenant une vitesse de pompe adéquate (c'est-à-dire ≥ 300 mL/min).

Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data.

BACKGROUND: Uptake of self-testing and self-management of oral anticoagulation [corrected] has remained inconsistent, despite good evidence of their effectiveness. To clarify the value of self-monitoring of oral anticoagulation, we did a meta-analysis of individual patient data addressing several important gaps in the evidence, including an estimate of the effect on time to death, first major haemorrhage, and thromboembolism. METHODS: We searched Ovid versions of Embase (1980-2009) and Medline (1966-2009), limiting searches to randomised trials with a maximally sensitive strategy. We approached all authors of included trials and requested individual patient data: primary outcomes were time to death, first major haemorrhage, and first thromboembolic event. We did prespecified subgroup analyses according to age, type of control-group care (anticoagulation-clinic care vs primary care), self-testing alone versus self-management, and sex. We analysed patients with mechanical heart valves or atrial fibrillation separately. We used a random-effect model method to calculate pooled hazard ratios and did tests for interaction and heterogeneity, and calculated a time-specific number needed to treat. FINDINGS: Of 1357 abstracts, we included 11 trials with data for 6417 participants and 12,800 person-years of follow-up. We reported a significant reduction in thromboembolic events in the self-monitoring group (hazard ratio 0·51; 95% CI 0·31-0·85) but not for major haemorrhagic events (0·88, 0·74-1·06) or death (0·82, 0·62-1·09). Participants younger than 55 years showed a striking reduction in thrombotic events (hazard ratio 0·33, 95% CI 0·17-0·66), as did participants with mechanical heart valve (0·52, 0·35-0·77). Analysis of major outcomes in the very elderly (age ≥85 years, n=99) showed no significant adverse effects of the intervention for all outcomes. INTERPRETATION: Our analysis showed that self-monitoring and self-management of oral coagulation is a safe option for suitable patients of all ages. Patients should also be offered the option to self-manage their disease with suitable health-care support as back-up. FUNDING: UK National Institute for Health Research (NIHR) Technology Assessment Programme, UK NIHR National School for Primary Care Research.

Evaluation of intraperitoneal vancomycin in peritoneal dialysis-associated peritonitis.

BACKGROUND: Intraperitoneal (IP) vancomycin is recommended as one of the treatment options for gram-positive coverage in the management of peritoneal dialysis (PD)-associated peritonitis. There is a lack of literature supporting the optimal dose and approach to vancomycin therapeutic drug-level monitoring. METHODS: A retrospective chart review was conducted using the BC Renal Agency PROMIS Database and our hospital records from 1 June 2011 to 1 July 2019. Adult patients with PD-associated peritonitis who received IP vancomycin and had at least one serum vancomycin level drawn were included. All patients received a loading dose of 30 mg/kg, which was repeated every 3-5 days depending on PD modality. Serum vancomycin levels were drawn prior to the second vancomycin dose, then at the discretion of the prescriber. The primary end point was the rate of therapeutic serum vancomycin levels ≥15 mg/L. RESULTS: Twenty-three episodes of PD-associated peritonitis in 20 patients met the eligibility criteria. Only 15/23 serum vancomycin levels were drawn appropriately after the first dose. Sixty per cent of these levels were subtherapeutic at <15 mg/L. All subsequent serum vancomycin levels were above the therapeutic target. Most peritonitis episodes (78%) achieved resolution of infection. Residual kidney function was not significantly correlated with serum vancomycin levels (p = 0.19). CONCLUSIONS: An IP vancomycin regimen of 30 mg/kg every 3-5 days resulted in subtherapeutic serum vancomycin levels in most patients following the loading dose but therapeutic levels thereafter. A large percentage of vancomycin levels were drawn inappropriately due to misalignment of outpatient follow-up visits and timing of blood work.

Evaluation of Statin Use and Prescribing in Patients with Chronic Kidney Disease Not Receiving Treatment with Kidney Transplant or Dialysis.

BACKGROUND: Chronic kidney disease (CKD) is a risk factor for cardiovascular disease. The Kidney Disease Improving Global Outcomes 2013 guidelines and the Canadian Cardiovascular Society 2016 guidelines recommend statins for primary prevention of cardiovascular disease in CKD patients aged 50 years or older who are not receiving treatment with kidney transplant or dialysis. OBJECTIVES: To evaluate statin use for patients in the Vancouver General Hospital Kidney Care Clinic (VGH KCC) and to gain insight into the KCC nephrologists' practices and perspectives regarding the prescribing of statins for patients with CKD. METHODS: The study comprised 2 parts. Part 1 consisted of a cross-sectional study of all statin-eligible patients in the VGH KCC followed by a retrospective chart review. In the chart review, data were collected for 250 statin users and 250 non-users. Logistic regression analyses were performed to determine associations between demographic variables and statin use or non-use. Part 2 was an electronic survey of VGH KCC nephrologists. RESULTS: Of the 813 statin-eligible patients, 512 (63%) were taking a statin. Patients were approximately 5 times more likely to be receiving statin therapy when it was indicated for secondary versus primary prevention (adjusted odds ratio 4.64, 95% confidence interval 2.95-7.47). Eight of the 9 KCC nephrologists completed the survey, and 7 (87.5%) of these respondents indicated that they never or rarely prescribed statins themselves to KCC patients for primary prevention. However, the same number reported that they sometimes or often suggested statin initiation to family physicians. Three of the respondents indicated agreement with guideline recommendations, but many stated that the decision for statin initiation should be individualized to the patient. Strategies to improve statin prescribing rates that were endorsed by respondents included educating family physicians, creating preprinted orders and laboratory requisitions for statin initiation, providing educational materials about statins to patients, and implementing a protocol for KCC pharmacists to counsel patients about statins. CONCLUSIONS: Many statin-eligible VGH KCC patients were not receiving statin therapy, and most of the KCC nephrologists considered statin prescribing as a role for family physicians. Within the KCC, future directions will be to develop a standardized approach to identify patients who would benefit from statin therapy, and to implement strategies to improve statin prescribing rates in appropriate patients.

CONTEXTE: L'insuffisance rénale chronique (IRC) est un facteur de risque de maladie cardiovasculaire. Les directives du Kidney Disease Improving Global Outcomes de 2013 et celles de la Société canadienne de cardiologie de 2016 recommandent l'utilisation de statines comme mode de prévention principal des maladies cardiovasculaires par les patients âgés d'au moins 50 ans et souffrant d'IRC, qui ne reçoivent pas de traitement par greffe rénale ou dialyse. OBJECTIFS: Évaluer l'utilisation des statines pour les patients résidant au Vancouver General Hospital Kidney Care Clinic (VGH KCC) et améliorer la compréhension des pratiques et points de vue des néphrologues de la KCC concernant la prescription de statines aux patients souffrant d'une IRC. MÉTHODES: L'étude comportait deux parties. La première consistait en une étude transversale de tous les patients admis à recevoir des statines au VGH KCC, suivie d'un examen rétrospectif des dossiers. Les données destinées à cet examen ont été recueillies auprès de 250 utilisateurs de statines et de 250 non-utilisateurs. Les analyses de régression logistique ont permis de déterminer les associations entre les variables démographiques et l'utilisation (ou non) de statines. La deuxième partie consistait en une enquête menée électroniquement auprès des néphrologues du VGH KCC. RÉSULTATS: Des 813 patients admissibles à l'utilisation de statines, 512 (63 %) en prenaient déjà. Les patients avaient environ cinq fois plus de chances de recevoir un traitement par statines, lorsque celles-ci étaient indiquées pour la prévention secondaire ou primaire (rapport de cote révisé 4,64, 95 % intervalle de confiance 2,95 ­ 7,47). Huit des neuf néphrologues de la KCC ont participé à l'enquête et sept (87,5 %) d'entre eux ont indiqué qu'ils n'avaient jamais, ou rarement, prescrit de statines aux patients du KCC dans le cadre d'une intervention primaire. Cependant, le même nombre de répondants a indiqué avoir parfois ou souvent proposé aux médecins de famille de commencer un traitement aux statines. Trois répondants ont indiqué être d'accord avec les recommandations préconisées dans les directives, mais bon nombre des néphrologues interrogés ont signalé que la décision d'entreprendre un tel traitement devait être individualisée. Les stratégies visant à améliorer les taux de prescription de statines approuvées par les répondants comprenaient la sensibilisation des médecins de famille, la création d'ordonnances et de demandes d'analyse en laboratoire préimprimées pour entreprendre un traitement aux statines, l'offre aux patients de matériel de formation sur le sujet et la mise en place d'un protocole pour les pharmaciens de la KCC leur permettant de conseiller les patients. CONCLUSIONS: Beaucoup de patients admissibles à un traitement aux statines du VGH KCC ne le recevaient pas, et la plupart des néphrologues de la KCC considéraient que la prescription de ce type de traitement relevait des médecins de famille. Au sein de la KCC, les orientations futures consisteront à élaborer une approche standardisée pour identifier les patients qui tireraient profit d'une thérapie aux statines et à mettre en place des stratégies visant à améliorer les taux de prescription de statines aux patients concernés.

Evaluation of 2 weight-based protocols for administration of heparin.

BACKGROUND: In 1996, a weight-based protocol for administration of heparin was implemented and assessed at the authors' institution. Since then, several modifications have been made, including introduction of a lower-target protocol. These changes warranted re-evaluation of the standard and lower-target protocols. OBJECTIVE: To determine and compare the efficacy and safety of the standard and lower-target protocols for heparin administration and to descriptively compare these findings with the original 1996 protocol. METHODS: This 5-month retrospective, observational study involved 100 consecutive patients, 50 assigned to each of the 2 current protocols (standard and lower target), who were treated between September 2006 and January 2007. The primary outcomes were efficacy, represented by the time to achieve partial thromboplastin time (PTT) above the lower limit of the therapeutic range and within the therapeutic range, and safety, as indicated by the incidence of major bleeding and thromboembolic events over the entire course of heparin therapy. RESULTS: There were no significant differences between the standard and lower-target protocols with respect to median time to achieve PTT above the lower limit of the therapeutic range (6.0 h versus 6.3 h, respectively; p = 0.24) or median time to achieve PTT within the therapeutic range (14.4 h versus 14.3 h, respectively; p = 0.93). Compared with the original 1996 protocol, these protocols appeared to have shorter times to achieve both of these outcomes. The rate of adverse events was infrequent, with fewer episodes of major bleeding (1%, for both current protocols combined) than in the 1996 study (10%). CONCLUSIONS: The 2 current weight-based protocols for administration of heparin appeared to have similar efficacy and safety and appeared to perform at least as well as the original 1996 protocol.

Effectiveness of a hepatitis B vaccination program at two tertiary hemodialysis centers.

INTRODUCTION: Hemodialysis (HD) patients are at increased risk of hepatitis B infection in comparison to the general population. Despite a more intensified hepatitis vaccination regimen, response rates in HD patients are typically low. The study was conducted to quantify response rate to a new hepatitis B vaccination protocol initiated in late 2015, determine risk factors affecting response rate, and assess adherence to protocol. METHODS: This retrospective chart review evaluated all HD patients eligible for hepatitis B vaccination in two large dialysis clinics from initiation of the hepatitis B protocol to July 2017. Recombinant hepatitis vaccine (Recombivax® HB) 40 µg was administered in a 3-dose regimen at months 0, 1, and 6 to patients with hepatitis B surface antibodies (anti-HBs) <10 mIU/mL. A repeat series was given if anti-HBs levels remained below 10 mIU/mL after the first series. A booster dose was given if anti-HBs titers fell below 10 mIU/mL after initial response to a second series vaccination. FINDINGS: Of 411 patients at the two HD centers, 142 patients received hepatitis B vaccination with a total of 168 vaccine courses given, series 1: n = 86, series 2: n = 60 and booster: n = 22. Response rates to vaccination were 61.4%, 58.3%, and 81.8%, respectively. In univariate analysis, adherence to protocol significantly affected response rate (P = 0.035). A multivariate analysis assessing response rates to series 1, 2 or booster confirmed that adherence was a significant risk factor (OR = 2.2; 95% CI 1.4-3.4; P = 0.0005). DISCUSSION: This was the first study to examine adherence to regimen and identified adherence as an important predictor of vaccine response. Adherence is one of the few modifiable risk factors that can be optimized in an effort to improve response to hepatitis B vaccination.

Creation of a Natural Health Products Database for Assessing Safety for Patients with Chronic Kidney Disease or Renal Transplant.

INTRODUCTION: There is a lack of published safety information on the use of natural health products (NHPs) for patients with chronic kidney disease (CKD) or renal transplant. OBJECTIVE: To create an online database to provide evidence-based safety recommendations for commonly used NHPs, specific to patients with CKD or renal transplant. METHODS: NHPs used by CKD and transplant patients in British Columbia were identified from the records of the BC Provincial Renal Agency. For each NHP, several databases (MEDLINE, Embase, Lexi-Natural Products, PubMed Dietary Supplement Subset, and Natural Medicines) were searched for any information pertaining to dosage, adverse drug reactions, drug interactions, immunomodulatory effects, and pharmacokinetics in patients with renal disease. Each NHP was given 1 of 4 safety ratings: likely safe, possibly safe, possibly unsafe, and likely unsafe. An NHP was classified as "possibly unsafe" for patients with renal transplant if it had demonstrated in vitro immunomodulatory effects and/or significant interactions with transplant medications due to effects on the cytochrome P450 3A4 isozyme. RESULTS: Of the 19 627 BC-registered patients with renal disease (as of August 2014), 4122 (21%) were using one or more NHPs. The Herbal-CKD website (www.herbalckd.com) was created in 2015 to provide information about 47 commonly used NHPs and 2 known nephrotoxins (aristolochic acid and silver). This website provides a systematic evaluation of safety information for selected NHPs for patients with CKD (both nondialysis and dialysis-dependent) and kidney transplant. The most common NHP safety classification was "possibly safe", reflecting the paucity of studies in renal populations and the availability of safety data for the general population. Limitations of the website include difficulty in interpreting and generalizing the safety literature because most NHP formulations are not standardized, and others are combination products. CONCLUSION: The website www.herbalckd.com provides an easy-to-use, evidence-based tool for health care professionals to assess the safety of NHPs for CKD and transplant patients.

CONTEXTE: On observe qu'il n'existe que très peu d'information publiée sur l'innocuité des produits de santé naturels (PSN) pour les patients souffrant d'insuffisance rénale chronique ou ayant subi une greffe rénale. OBJECTIF: Créer une base de données en ligne qui sert à fournir des recommandations de sécurité fondées sur des données probantes au sujet des PSN les plus employés spécifiquement à l'intention des patients atteints d'insuffisance rénale chronique ou ayant subi une greffe rénale. MÉTHODES: Les PSN utilisés par les patients souffrant d'insuffisance rénale chronique ou ayant subi une greffe rénale ont été répertoriés d'après les dossiers de la BC Provincial Renal Agency. Pour chaque PSN, plusieurs bases de données (MEDLINE, Embase, Lexi-Natural Products, PubMed Dietary Supplement Subset et Natural Medicines) ont été interrogées afin d'y chercher des informations sur la posologie, les réactions indésirables aux médicaments, les interactions médicamenteuses, les effets immunomodulateurs et la pharmacocinétique chez les patients atteints d'insuffisance rénale. Chaque PSN s'est vu attribuer l'un de quatre degrés de sécurité : probablement sécuritaire, possiblement sécuritaire, possiblement nocif et probablement nocif. Un PSN était classé « possiblement nocif ¼ pour les patients ayant subi une greffe rénale s'il a manifesté in vitro des effets immunomodulateurs ou des interactions importantes avec les médicaments antirejet à cause de l'isozyme 3A4 du cytochrome P450. RÉSULTATS: Parmi les 19 627 patients insuffisants rénaux inscrits en Colombie-Britannique, 4 122 (21 %) utilisaient au moins un PSN (en date d'août 2014). Le site Web HerbalCKD (www.herbalckd.com) a été créé en 2015 afin de fournir de l'information sur 47 des PSN les plus utilisés et sur deux néphrotoxines connues (l'acide aristolochique et l'argent). Ce site Web offre une évaluation systématique des informations sur l'innocuité de PSN choisis qui pourraient être utilisés par les patients souffrant d'insuffisance rénale chronique (dialysés ou non) ou ayant subi une greffe rénale. Les PSN étaient le plus souvent classés sous « possiblement sécuritaire ¼, ce qui souligne le peu d'études auprès des populations souffrant de troubles rénaux et la disponibilité de données sur l'innocuité dans la population générale. Parmi les limites du site Web, on compte la difficulté à interpréter et à généraliser la littérature sur l'innocuité parce que la plupart des formules de PSN ne sont pas normalisées et que certains PSN sont un mélange de substances. CONCLUSION: Le site Web www.herbalckd.com représente pour les professionnels de la santé un outil simple et fondé sur des données probantes leur permettant d'évaluer l'innocuité de PSN pour les patients atteints d'insuffisance rénale chronique ou ayant subi une greffe rénale.

Clinical impact of point-of-care vs laboratory measurement of anticoagulation.

Patients using anticoagulation point-of-care (POC) monitors are advised to periodically test these systems against laboratory methods to monitor performance. The international normalized ratio (INR), however, can vary between test systems owing to different instrument-reagent combinations. In a randomized study evaluating warfarin self-management, we compared INR measured by patients on a POC monitor (ProTime, International Technidyne Corporation, Edison, NJ) with those obtained at a hospital laboratory within 1 hour Ninety-one paired INR determinations from 55 patients met inclusion criteria. Clinical agreement in which POC and laboratory INR were within or outside the target INR range occurred in 56 (62%) of 91 cases (kappa = 0.35). The mean (SD) difference between POC and laboratory INR was 0.44 (0.61). Six pairs differed by 1 or more INR units, 3 at study initiation resulting in POC monitor replacement. The accuracy of INR self-testing with ProTime was acceptable. The small failure rate of INR agreement might be clinically important, suggesting the need for external quality control systems.

Patient self-management of oral anticoagulation: a review.

Self-management of warfarin is an evolving strategy that involves self-testing of the international normalized ratio using a point-of-care device and adjustment of warfarin dosage by the patient using a dosage-adjustment nomogram. There is mounting evidence from clinical trials that self-management of warfarin is feasible and is potentially superior to conventional management by physicians in maintaining anticoagulation control. Some advantages of this strategy are convenience, rapid availability of results with timely adjustment of warfarin dosages, increased patient responsibility for their own therapy and enhanced patient satisfaction. Access to point-of-care instruments may prove particularly valuable for patients without ready access to laboratories, frequent travellers who are often away from their home laboratory for extended periods of time and those who experience difficulties with venous blood collection. Self-management may be considered for carefully selected and properly trained individuals. Information from several ongoing clinical trials will aid in determining the value of anticoagulation self-management with respect to complication rates and economic outcomes.

A randomized trial of patient self-managed versus physician-managed oral anticoagulation.

BACKGROUND: Self-management (SM) of warfarin by patients is an attractive strategy, particularly if it improves anticoagulation control and can be done safely under minimal physician supervision. OBJECTIVE: To compare the effect of SM with physician-management (PM) on the maintenance of therapeutic anticoagulation. METHODS: A randomized, open-label eight-month trial was performed. Patients 18 years of age and older were eligible if they were receiving warfarin for at least one month before enrolment and required anticoagulation for at least one year to a target international normalized ratio (INR) of 2.0 to 3.0 or 2.5 to 3.5. Exclusion criteria were a known hypercoaguable disorder, mental incompetence, a language barrier or an inability to attend training sessions. Patients randomly assigned to SM tested their INR using a point-of-care device (Pro Time Microcogulation System, International Technidyne Corporation, USA) and adjusted their warfarin doses using a nomogram. Patients randomly assigned to PM received usual care from their general practitioner. The primary outcome was to demonstrate 20% improvement in anticoagulation control by SM. RESULTS: One hundred forty patients were randomly assigned (70 per group). Thirteen patients dropped out of SM early due to an inability to self-manage. Based on intention-to-treat analysis, there was no difference in the proportion of INR in range (SM 64.8% versus PM 58.7%, P=0.23) or time in target range (SM 71.8% versus PM 63.2%, P=0.14). Patients managing their own therapy spent less time below the therapeutic range (15.0% versus 27.3%, P=0.04). There were three major complications of thrombosis or bleeding, all occurring in the PM arm. All patients who completed SM preferred to continue with that strategy. CONCLUSIONS: SM was not significantly better than PM in maintaining therapeutic anticoagulation. SM was feasible and appeared safe in the present study population.

Efficacy of intradialytic parenteral nutrition in malnourished hemodialysis patients.

The efficacy of intradialytic parenteral nutrition (IDPN) in malnourished hemodialysis patients was studied. All patients at a large tertiary care institution who received IDPN for one month or longer between June 1997 and December 2000 were included in the study. The IDPN formulation contained 10% amino acids 250 or 500 mL, 50% dextrose 250 mL, and 20% fat emulsion 250 mL. IDPN was administered during each thrice-weekly hemodialysis session. Patient data were collected 6 and 3 months before IDPN therapy began, at baseline, and 3, 6, 9, and 12 months after the therapy began. Therapeutic efficacy was assessed by the percent change from baseline in dry body weight and serum albumin concentration. Twenty-six courses of IDPN in 24 patients met the study's inclusion criteria. The mean duration of treatment was 4.3 months. Dry body weights were significantly lower 6 and 3 months before the start of IDPN therapy than at baseline and significantly higher 6, 9, and 12 months after the start of therapy. Serum albumin levels were also significantly higher at 3 and 9 months than at baseline. The percentage of treatment courses in which patients had a serum albumin concentration of > or = 34 g/L was 12% at baseline, 39% at 6 months, and 47% at 9 months. Adverse effects consisted primarily of excess fluid gain and hyperglycemia. IDPN therapy significantly increased body weight and serum albumin levels in malnourished hemodialysis patients.

Evaluation of captopril for the management of hypertension in autonomic dysreflexia: a pilot study.

OBJECTIVE: To evaluate the efficacy of captopril for management of hypertensive urgencies in autonomic dysreflexia. DESIGN: A 1-year, prospective, open-label pilot study. SETTING: Rehabilitation hospital. PATIENTS: Twenty-six consecutive patients older than 15 years with spinal cord injury above T6. INTERVENTIONS: During an autonomic dysreflexia episode, captopril 25mg was administered sublingually if systolic blood pressure (SBP) was at or above 150mmHg despite the use of nondrug measures. If SBP remained elevated 30 minutes after captopril administration, 1 dose of immediate-release nifedipine 5mg was given as rescue by the bite and swallow method and repeated, if necessary, in 15 minutes. MAIN OUTCOME MEASURE: SBP 30 minutes after captopril administration at initial autonomic dysreflexia episode. RESULTS: A total of 33 autonomic dysreflexia episodes were documented, of which 18 episodes in 5 patients were treated with drug therapy. Captopril alone was effective in 4 of 5 initial episodes (80%). Mean SBPs at baseline and 30 minutes after captopril were 178+/-18mmHg and 133+/-28mmHg, respectively. There were no cases of reactive hypotension. The addition of nifedipine successfully reduced SBP in the remaining patient. Of the combined 18 initial and repeat autonomic dysreflexia episodes, 94% were successfully treated with our protocol. CONCLUSION: Captopril appears to be safe and effective for autonomic dysreflexia management.

Management of anemia in erythropoietin-resistant hemodialysis patients.

BACKGROUND: Human recombinant erythropoietin (rHuEPO) is administered to patients with end-stage renal disease for treatment of anemia. OBJECTIVE: To assess the impact of a structured team approach to anemia management in rHuEPO-resistant hemodialysis patients. METHODS: This was an 8-month prospective, open-label, quality-improvement initiative. Nineteen patients in a 160-bed hemodialysis unit receiving rHuEPO doses >300 units/kg/wk were defined as rHuEPO-resistant. Hemoglobin (Hb), iron indices, parathyroid hormone, folate, B12, aluminum, and reticulocyte counts were determined at baseline. The former 3 parameters were followed every 6, 12, and 26 weeks, respectively. Vascular access flow was regularly assessed via ultrasonic dilution methodology. Target Hb was 12.0-13.5 g/dL. All factors potentially contributing to rHuEPO resistance were assessed and, if possible, treated every 6 weeks by a dedicated anemia team. Downward rHuEPO dosage adjustments of 12.5-25% to the closest 1000 units were considered if underlying causes of rHuEPO resistance could not be identified or reversed, or if the Hb rose beyond the target level. RESULTS: Dysfunctional vascular access and iron deficiency were the predominant treatable factors associated with rHuEPO resistance. At 8 months, mean rHuEPO dosage decreased significantly from 469 to 319 units/kg/wk (p < 0.001) and mean Hb increased significantly from 10.6 to 11.6 g/dL (p = 0.023). Eight-month cost savings approximated $45 000 (CDN$). CONCLUSIONS: A structured team approach to the management of rHuEPO-resistant patients was successful in significantly lowering rHuEPO dosage with improvement in serum Hb at a substantial cost savings.