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A Multicenter Randomized Clinical Trial of Hemodialysis Access Blood Flow Surveillance Compared to Standard of Care: The Hemodialysis Access Surveillance Evaluation (HASE) Study.

ABSTRACT: Introduction:Arteriovenous (AV) access thrombosis remains 1 of the most troubling AV access-related complications affecting hemodialysis patients. It necessitates an urgent and occasionally complicated thrombectomy procedure and increases the risk of AV access loss. AV access stenosis is found in the majority of thrombosed AV accesses. The routine use of AV access surveillance for the early detection and management of stenosis to reduce the thrombosis rate remains controversial. Methods:We have conducted a multicenter, prospective, randomized clinical trial comparing the standard of care coupled with ultrasound dilution technique (UDT) flow measurement monthly surveillance with the standard of care alone. Results:We prospectively randomized 436 patients with end-stage renal disease on hemodialysis with arteriovenous fistula (AVF) or arteriovenous graft (AVG) using cluster (shift) randomization to surveillance and control groups. There were no significant differences in the baseline demographic data between the 2 groups, except for ethnicity (P = 0.017). Patients were followed on average for 15.2 months. There were significantly less per-patient thrombotic events (Poisson rate) in the surveillance group (0.12/patient) compared with the control group (0.23/patient) (P = 0.012). There was no statistically significant difference in the total number of procedures between the 2 groups, irrespective of whether thrombectomy procedures were included or excluded, and no statistically significant differences in the rate of or time to the first thrombotic event or the number of catheters placed due to thrombosis. Conclusion:The use of UDT flow measurement monthly AV access surveillance in this multicenter randomized controlled trial reduced the per-patient thrombotic events without significantly increasing the total number of angiographic procedures. Even though there is a trend, surveillance did not reduce the first thrombotic event rate.

SUBMITTER: Salman L

PROVIDER: S-EPMC7609971 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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A Multicenter Randomized Clinical Trial of Hemodialysis Access Blood Flow Surveillance Compared to Standard of Care: The Hemodialysis Access Surveillance Evaluation (HASE) Study.

Salman Loay L Rizvi Abid A Contreras Gabriel G Manning Christina C Feustel Paul J PJ Machado Ivy I Briones Patricia L PL Jamal Aamir A Bateman Nicolle N Martinez Laisel L Tabbara Marwan M Vazquez-Padron Roberto I RI Asif Arif A

Kidney international reports 20200804 11

<h4>Introduction</h4>Arteriovenous (AV) access thrombosis remains 1 of the most troubling AV access-related complications affecting hemodialysis patients. It necessitates an urgent and occasionally complicated thrombectomy procedure and increases the risk of AV access loss. AV access stenosis is found in the majority of thrombosed AV accesses. The routine use of AV access surveillance for the early detection and management of stenosis to reduce the thrombosis rate remains controversial.<h4>Metho ...[more]

PMID: 33163714

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Project description:BackgroundThe benefit of access flow surveillance in preventing vascular access thrombosis and failure remains controversial, as many randomized clinical trials (RCTs) have failed to demonstrate consistent results. The aim of this study was to perform a meta-analysis including newly published RCTs with a subgroup analysis for arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs).MethodsA systematic review of the available literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. An electronic search was conducted using the MEDLINE, EMBASE, and Cochrane Library databases of RCTs conducted from 1970 to 2017 that involved access flow surveillance. As a result, 9 RCTs met our criteria. The control group was defined by indirect and various surveillance methods such as dynamic venous pressure measurement and physical examination. Conversely, the interventional group was defined as a noninvasive duplex ultrasound scan (USS) or ultrasound dilution that directly measured the flow of vascular access.ResultsThe studies included 990 patients comprising 658 native AVFs and 332 AVGs. The prevalence of diabetes was 29.3%and 30.5% in the interventional and control groups, respectively. The estimated overall pooled risk ratio (RR) of thrombosis was 0.782 [95% confidence interval (95% CI), 0.553-1.107; P?=?.17], favoring interventional group, although this was not statistically significant. In the subgroup analysis, the pooled RR of thrombosis was .562 (95% CI, 0.346-0.915; P?=?.02) for AVFs, which significantly favored the interventional group. Conversely, the pooled RR for AVGs was 1.104 (95% CI, 0.672-1.816; P?=?.70).ConclusionThe surveillance method to measure access flow through USS showed a significant benefit for reducing thrombosis in AVFs. The result encourages adherence to the current guidelines for AVFs. However, no benefit was found regarding AVGs. Recent guidelines with a "one-size-fits-all" approach may be revised to a "tailored-to-risk" approach.

Project description:Background and objectivesFistulas, the preferred form of hemodialysis access, are difficult to establish and maintain. We examined the effect of a multidisciplinary vascular access team, including nurses, surgeons, and radiologists, on the probability of using a fistula catheter-free, and rates of access-related procedures in incident patients receiving hemodialysis.Design, setting, participants, & measurementsWe examined vascular access outcomes in the first year of hemodialysis treatment before (2004-2005, preteam period) and after the implementation of an access team (2006-2008, early-team period; 2009-2011, late-team period) in the Calgary Health Region, Canada. We used logistic regression to study the probability of fistula creation and the probability of catheter-free fistula use, and negative binomial regression to study access-related procedure rates.ResultsWe included 609 adults (mean age, 65 [±15] years; 61% men; 54% with diabetes). By the end of the first year of hemodialysis, 102 participants received a fistula in the preteam period (70%), 196 (78%) in the early-team period (odds ratios versus preteam, 1.47; 95% confidence interval, 0.92 to 2.35), and 139 (66%) in the late-team period (0.85; 0.54 to 1.35). Access team implementation did not affect the probability of catheter-free use of the fistula (odds ratio, 0.87; 95% confidence interval, 0.52 to 1.43, for the early; and 0.89; 0.52 to 1.53, for the late team versus preteam period). Participants underwent an average of 4-5 total access-related procedures during the first year of hemodialysis, with higher rates in women and in people with comorbidities. Catheter-related procedure rates were similar before and after team implementation; relative to the preteam period, fistula-related procedure rates were 40% (20%-60%) and 30% (10%-50%) higher in the early-team and late-team periods, respectively.ConclusionIntroduction of a multidisciplinary access team did not increase the probability of catheter-free fistula use, but resulted in higher rates of fistula-related procedures.

Project description:ObjectivesComparing language-supported group antenatal care (gANC) and standard antenatal care (sANC) for Somali-born women in Sweden, measuring overall ratings of care and emotional well-being, and testing the feasibility of the outcome measures.DesignA quasi-experimental trial with one intervention and one historical control group, nested in an intervention development and feasibility study.SettingMidwifery-led antenatal care clinic in a mid-sized Swedish town.ParticipantsPregnant Somali-born women (<25 gestational weeks); 64 women in gANC and 81 in sANC.InterventionLanguage-supported gANC (2017-2019). Participants were offered seven 60-minute group sessions with other Somali-born women led by one to two midwives, in addition to 15-30 min individual appointments with their designated midwife.OutcomesPrimary outcomes were women's overall ratings of antenatal care and emotional well-being (Edinburgh Postnatal Depression Scale (EPDS)) in gestational week ≥35 and 2 months post partum. Secondary outcomes were specific care experiences, information received, social support, knowledge of pregnancy danger signs and obstetric outcomes.ResultsRecruitment and retention of participants were challenging. Of eligible women, 39.3% (n=106) declined to participate. No relevant differences regarding overall ratings of antenatal care between the groups were detected (late pregnancy OR 1.42, 95% CI 0.50 to 4.16 and 6-8 weeks post partum OR 2.71, 95% CI 0.88 to 9.41). The reduction in mean EPDS score was greater in the intervention group when adjusting for differences at baseline (mean difference -1.89; 95% CI -3.73 to -0.07). Women in gANC were happier with received pregnancy and birth information, for example, caesarean section where 94.9% (n=37) believed the information was sufficient compared with 17.5% (n=7) in standard care (p<0.001) in late pregnancy.ConclusionsThis evaluation suggests potential for language-supported gANC to improve knowledge acquisition among pregnant Somali-born women with residence in Sweden ˂10 years. An adequately powered randomised trial is needed to evaluate the effectiveness of the intervention.Trial registration numberClinicalTrials.gov Registry (NCT03879200).

Dataset Information

A Multicenter Randomized Clinical Trial of Hemodialysis Access Blood Flow Surveillance Compared to Standard of Care: The Hemodialysis Access Surveillance Evaluation (HASE) Study.

Publications

A Multicenter Randomized Clinical Trial of Hemodialysis Access Blood Flow Surveillance Compared to Standard of Care: The Hemodialysis Access Surveillance Evaluation (HASE) Study.

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