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Two phosphAte taRGets in End-stage renal disease Trial (TARGET): A Randomized Controlled Trial.

ABSTRACT: Hyperphosphatemia is common among recipients of maintenance dialysis and is associated with a higher risk of mortality and cardiovascular events. A large randomized trial is needed to determine whether lowering phosphate concentrations with binders improves patient-important outcomes. To inform such an effort we conducted a pilot randomized controlled trial.We conducted a randomized controlled trial of prevalent hemodialysis recipients already receiving calcium carbonate as a phosphate binder at five Canadian centers between March 31, 2014 and October 2, 2014. Participants were randomly allocated to 26 weeks of an intensive phosphate goal of 2.33-4.66 mg/dl (0.75-1.50 mmol/L) or a liberalized target of 6.20-7.75 mg/dl (2.00-2.50 mmol/L) by titrating calcium carbonate using a dosing nomogram. The primary outcome was the difference in the change in serum phosphate from randomization to 26 weeks.Fifty-three participants were randomized to the intensive group and 51 to the liberalized group. The median (interquartile range) daily dose of elemental calcium at 26 weeks was 1800 (1275-3000) mg in the intensive group, and 0 (0-500) mg in the liberalized group. The mean (SD) serum phosphate at 26 weeks was 4.53 (1.12) mg/dl (1.46 [0.36] mmol/L) in the intensive group and 6.05 (1.40) mg/dl (1.95 [0.45] mmol/L) in the liberalized group. Phosphate concentration in the intensive group declined by 1.24 (95% confidence interval, 0.75 to 1.74) mg/dl (0.40 [95% confidence interval, 0.24 to 0.56] mmol/L) compared with the liberalized group. There were no statistically significant differences between the two groups in the risk of hypercalcemia, hypocalcemia, parathyroidectomy, or major vascular events.It is feasible to achieve and maintain a difference in serum phosphate concentrations in hemodialysis recipients by titrating calcium carbonate. A large trial is needed to determine if targeting a lower serum phosphate concentration improves patient-important outcomes.

SUBMITTER: Wald R

PROVIDER: S-EPMC5460712 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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Two phosphAte taRGets in End-stage renal disease Trial (TARGET): A Randomized Controlled Trial.

Wald Ron R Rabbat Christian G CG Girard Louis L Garg Amit X AX Tennankore Karthik K Tyrwhitt Jessica J Smyth Andrew A Rathe-Skafel Andrea A Gao Peggy P Mazzetti Andrea A Bosch Jackie J Yan Andrew T AT Parfrey Patrick P Manns Braden J BJ Walsh Michael M

Clinical journal of the American Society of Nephrology : CJASN 20170526 6

<h4>Background and objectives</h4>Hyperphosphatemia is common among recipients of maintenance dialysis and is associated with a higher risk of mortality and cardiovascular events. A large randomized trial is needed to determine whether lowering phosphate concentrations with binders improves patient-important outcomes. To inform such an effort we conducted a pilot randomized controlled trial.<h4>Design, setting, participants, & measurements</h4>We conducted a randomized controlled trial of preval ...[more]

PMID: 28550080

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Project description:BACKGROUND:Given the importance of inflammation as a predictor of poor outcomes in End Stage Renal Disease (ESRD), reductions in inflammatory biomarkers have been proposed as a critical target in this population. This study targets chronic periodontitis, an oral inflammatory disease of microbial etiology causing persistent inflammation in ESRD. Unlike the previously reported episodic periodontal interventions, we propose to control periodontal inflammation with a continuous maintenance and oral health behavior modifications. We hypothesize that this strategy will improve systemic inflammation and oxidative stress, oral health and quality of life within the 6-month observation period. METHODS:The rePAIR (novel PAradigm to improve Inflammatory burden in ESRD) study is a pilot and feasibility, parallel-arm, and randomized controlled clinical trial that will recruit 72 ESRD subjects with periodontitis in a model of computerized block randomization. This trial aims to compare the effect of standard-of-care vs. repeated non-surgical periodontal therapy on systemic and oral inflammatory burden. This trial will recruit ESRD adult patients with periodontitis older than 21 years old with a minimum of 12 teeth and no history of periodontal treatment within a year. The trial will examine serum C-reactive protein (CRP) (primary outcome) as a biomarker of inflammation as well as interleukin-6 (IL-6), F2 isofurans and F2 isoprostanes (secondary outcomes) and compare their difference between groups from baseline to 6 months. The trial will also compare the difference between groups in patient-centered and clinical oral outcomes from baseline to 6 months. DISCUSSION:The trial follows a rigorous and transparent study design capturing elements such as pre-specified eligibility criteria, pre-specified primary and secondary outcomes, detailed intervention description to allow replication, intervention random allocation and concealment, blinding in outcome assessment, appropriate sample size calculations, explanation of interim analysis, as per CONSORT Guidelines. Further, gender diversity is secured not only at recruitment but also throughout the trial and during the analysis. Therefore, treatment response outcomes will be examined per gender category. In order to manage anticipated problems, the protocol has included alternative approaches. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03241511 . Registered on 7 August 2017.

Project description:BackgroundTaking into consideration the value of the oral health condition in geriatric people with end-stage renal disease (ESRD) associated with xerostomia and believing that salivary stimulants or substitutes could potentially be used to manage this condition. This study aimed to evaluate the clinical effectiveness of thyme honey as oral rinse in geriatric patients with ESRD using the subjective dry mouth score as a primary objective and to assess the effect of thyme honey on the salivary nitric oxide level, salivary flow rate, and salivary ph in addition to objective dry mouth score as a secondary objective.MethodsThis was a single blinded randomized controlled trial with two equal arms, the interventional arm (thyme honey oral rinse) and the control arm (saline). Twenty-eight geriatric patients with ESRD undergoing hemodialysis complained of xerostomia were recruited from the renal dialysis center. Patients in both arms followed the same administration protocol either with thyme honey oral rinse or saline. The following clinical parameters (the subjective and objective dry mouth scores, salivary flow rate, salivary ph, and salivary nitric oxide (NO) levels) were evaluated for both groups at different intervals (baseline, 1 week, and 1 month).ResultsIn the current study, it was found that both the subjective and objective dry mouth scores were significantly lower after one month of using thyme honey oral rinse (1.86 ± 0.66B) and (2.21 ± 0.43B) respectively, than the control group (3.07 ± 0.73B) and (3.07 ± 0.83B), respectively with a (p < 0.001). Also, the salivary flow rate was significantly higher after one month of using thyme honey oral rinse (1.56 ± 0.51A), than the control group (0.78 ± 0.27A) with a (p < 0.001). For the NO levels, there was a significant increase in measured value after 1 month in the intervention group (p < 0.001), while for the control group the change was not statistically significant (p = 0.166).ConclusionsThe results of the current study have revealed the efficacy of Thyme honey oral rinse in the management of xerostomia in geriatric patients with ESRD. Trial registration The ClinicalTrials.gov Identifier for this study is NCT05247008.

Project description:BACKGROUND AND OBJECTIVES:The US Centers for Medicare and Medicaid Services have mandated reducing early (30-day) hospital readmissions to improve patient care and reduce costs. Patients with ESKD have elevated early readmission rates, due in part to complex medical regimens but also cognitive impairment, literacy difficulties, low social support, and mood problems. We developed a brief family consultation intervention to address these risk factors and tested whether it would reduce early readmissions. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:One hundred twenty hospitalized adults with ESKD (mean age=58 years; 50% men; 86% black, 14% white) were recruited from an urban, inpatient nephrology unit. Patients were randomized to the family consultation (n=60) or treatment-as-usual control (n=60) condition. Family consultations, conducted before discharge at bedside or via telephone, educated the family about the patient's cognitive and behavioral risk factors for readmission, particularly cognitive impairment, and how to compensate for them. Blinded medical record reviews were conducted 30 days later to determine readmission status (primary outcome) and any hospital return visit (readmission, emergency department, or observation; secondary outcome). Logistic regressions tested the effects of the consultation versus control on these outcomes. RESULTS:Primary analyses were intent-to-treat. The risk of a 30-day readmission after family consultation (n=12, 20%) was 0.54 compared with treatment-as-usual controls (n=19, 32%), although this effect was not statistically significant (odds ratio, 0.54; 95% confidence interval, 0.23 to 1.24; P=0.15). A similar magnitude, nonsignificant result was observed for any 30-day hospital return visit: family consultation (n=19, 32%) versus controls (n=28, 47%; odds ratio, 0.53; 95% confidence interval, 0.25 to 1.1; P=0.09). Per protocol analyses (excluding three patients who did not receive the assigned consultation) revealed similar results. CONCLUSIONS:A brief consultation with family members about the patient's cognitive and psychosocial risk factors had no significant effect on 30-day hospital readmission in patients with ESKD.

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Two phosphAte taRGets in End-stage renal disease Trial (TARGET): A Randomized Controlled Trial.

Publications

Two phosphAte taRGets in End-stage renal disease Trial (TARGET): A Randomized Controlled Trial.

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