P0927THE IMPACT OF NUTRITIONAL EDUCATION ON PHOSPHORUS CONTROL IN HEMODIALYSIS PATIENTS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Kariem Mohamed Salem ◽  
Mohammed Kamal Nassar ◽  
Doaa Hamed El-Sabakhawi ◽  
Ousama Elshahat ◽  
Malak Nabil Amin ◽  
...  
Keyword(s):  
Laboratory Tests ◽  
Intervention Group ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
Nutritional Education ◽  
Teaching Aids ◽  
Significant Difference

Abstract Background and Aims Hyperphosphatemia is frequently encountered in hemodialysis patients and is an important risk factor of cardiovascular diseases. It is usually difficult to be managed by phosphate binders and hemodialysis. This study was carried out to assess the effect of nutritional education (NE) on the control of serum phosphorus level in hemodialysis patients. Method An open label, single center randomized controlled trial was conducted in the nephrology department, New Mansoura General Hospital, Egypt. One hundred hemodialysis patients were randomized into two groups; intervention Group (IG) (n=50) subjected to NE program for 3 months and Control group (CG) (n=50) received the usual care. Nutritional education was applied for the intervention group, by a trained renal dietitian, in the form of educational sessions, booklets, procures, audio visual teaching aids and patient-tailored counselling. Nutritional evaluation was done for all patients using dietary history, 24 hour diet recall sheet and malnutrition inflammation score (MIS) in addition to assessment of anthropometrics measurements and routine laboratory tests before randomization and at the end of the study. Results Three months after randomization, body mass index, waist circumference and midarm muscle circumference (MAMC) were significantly lower among IG versus the CG (p=0.04, 0.04 and 0.004 respectively). MIS score was significantly lower among the IG compared to the CG (p=0.02). Regarding laboratory tests, serum phosphorus level and calcium X phosphorus product were significantly lower among IG compared to the CG at the end of the study (p<0.001 and =0.04 respectively) with a percent change of serum phosphorus of -13.8 ± 21.41 after NE. The percentage of patients with hyperphosphatemia (> 5.5 mg/dl) were significantly lower in the IG at the end of study (p=0.04). Other laboratory tests including serum albumin, hemoglobin level, iron status and urea reduction ratio did not show any significant difference between both groups. Conclusion NE applied to dialysis patients added to the control of hyperphosphaemia without exposing the patients to the risk of malnutrition, resulting from injudicious dietary restrictions.

scholarly journals Therapeutic Effects of Add-On Tenapanor for Hemodialysis Patients with Refractory Hyperphosphatemia

2021 ◽  
pp. 1-11
Author(s):  
Takashi Shigematsu ◽  
Yotaro Une ◽  
Kazuaki Ikejiri ◽  
Hironori Kanda ◽  
Masafumi Fukagawa ◽  
...  
Keyword(s):  
Placebo Group ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Therapeutic Effects ◽  
Efficacy And Safety ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
The Mean ◽  
Phosphorus Levels

<b><i>Introduction:</i></b> Phosphate binders are used to treat hyperphosphatemia. Some patients have inappropriately controlled serum phosphorus levels, which may occur for many reasons, including a high pill burden and adverse events (AEs). Tenapanor selectively inhibits the passive paracellular transfer of phosphate in the gastrointestinal tract, thereby reducing serum phosphorus levels. This novel mechanism of action may contribute to improved phosphate management. The efficacy and safety of tenapanor have not been evaluated in Japanese patients with high serum phosphorus levels despite treatment with phosphate binders. This study aimed to assess the efficacy and safety of add-on tenapanor therapy for reducing serum phosphorus levels in this population. <b><i>Methods:</i></b> This multicenter, double-blind, randomized, placebo-controlled trial enrolled patients with refractory hyperphosphatemia undergoing hemodialysis. Patients were randomly assigned in a 1:1 ratio to receive tenapanor or placebo as an add-on to their phosphate binder regimen for 6 weeks. Change in serum phosphorus levels at week 6 (day 43) compared with the baseline value (day 1, week 0) (primary endpoint), achievement of target serum phosphorus levels (serum phosphorus level ≤6.0 or ≤5.5 mg/dL), and safety, based on all AEs and drug-related AEs, were among the outcomes evaluated. <b><i>Results:</i></b> In total, 24 patients were randomly assigned to the placebo group and 23 to the tenapanor group. The mean serum phosphorus level decreased from 7.01 mg/dL on day 1 to 6.69 mg/dL on day 43 in the placebo group and from 6.77 mg/dL on day 1 to 4.67 mg/dL on day 43 in the tenapanor group. In the placebo and tenapanor groups (modified intent-to-treat population), the mean (standard deviation) change in the serum phosphorus level at day 43 (last observation carried forward [LOCF]) was 0.08 (1.52) mg/dL and −1.99 (1.24) mg/dL, respectively, with a between-group difference of −2.07 (95% confidence interval: −2.89, −1.26; <i>p</i> &#x3c; 0.001). The target achievement rate (serum phosphorus level ≤6.0 mg/dL at week 6 [LOCF]) was 37.5 and 87.0% in the placebo and tenapanor groups, respectively. Diarrhea was the most common drug-related AE, and it occurred in 8.3 and 65.2% of patients in the placebo and tenapanor groups, respectively. No specific AEs were observed with add-on tenapanor or with phosphate binders. <b><i>Discussion/Conclusion:</i></b> Therapy with existing phosphate binders and add-on tenapanor resulted in a significant decrease in serum phosphorus level compared with the placebo group in patients with refractory hyperphosphatemia despite treatment with phosphate binders. No new safety signals were raised, and add-on tenapanor was generally well tolerated.

scholarly journals Comparison of the Effect of Enteral Feeding through the Bolus and Continuous Methods on Serum Phosphorus and Glucose Levels in Patients with Mechanical Ventilation: A Randomized Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Javad Seyyedi ◽  
Zahra Rooddehghan ◽  
Mostafa Mohammadi ◽  
Shima Haghani
Keyword(s):  
Mechanical Ventilation ◽  
Enteral Feeding ◽  
Intervention Group ◽  
Serum Phosphorus ◽  
Control Group ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
Glucose Levels ◽  
Significant Difference ◽  
Feeding Methods

Introduction. Patients who are under mechanical ventilation in intensive care units need to have nutritional support. Also, feeding methods affect serum phosphorus and glucose levels, which are very important in weaning patients off the ventilator. Thus, this study is to compare the effects of both bolus and continuous enteral feeding methods on serum phosphorus and glucose levels in patients with mechanical ventilation. Methods. In this clinical trial study, 34 patients in the intensive care unit of Imam Khomeini Hospital affiliated to the Tehran University of Medical Sciences satisfied inclusion criteria and were randomly divided into control and intervention groups. Sampling was done between October and February 2018. The intervention group received continuous enteral feeding for one week, and the control group received nutrition by the bolus method. The blood glucose level was measured every six hours, and the serum phosphorus level was recorded at the beginning and the end of the intervention, based on the data entry form with respect to all ethical considerations. Data analysis was done by SPSS-20 software. Results. The serum phosphorus level was significantly increased in the intervention group (P=0.004) and in the control group (P<0.001) and was compared with the previous intervention. No significant difference was found between the intervention and control groups before and after the intervention (P=0.22) and also one week after the intervention (P=0.14). There was also no significant difference between the glucose levels from day 1 to day 7 in the control group (P=0.33) and the intervention group (P=0.086). Discussion. Nutritional support in both bolus and continuous methods increased the serum phosphorus level. It indicates the importance of the nutritional method in controlling the phosphorus level in critically ill patients. However, there was no difference between the effects of dietary methods on blood glucose control.

scholarly journals P1404A PHASE 2 OPEN-LABEL, SINGLE-ARM, FIRST JAPANESE STUDY OF TENAPANOR, A NOVEL PHOSPHATE ABSORPTION INHIBITOR, FOCUSING ON PILL BURDEN DECREASE IN PATIENTS WITH HYPERPHOSPHATEMIA UNDERGOING HEMODIALYSIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Tadao Akizawa ◽  
Hironori Kanda ◽  
Masayuki Takanuma ◽  
Jun Kinoshita ◽  
Masafumi Fukagawa
Keyword(s):  
Primary Endpoint ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Pill Burden ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
Open Label ◽  
Serious Adverse Events ◽  
Phosphate Absorption ◽  
Phosphorus Control

Abstract Background and Aims Phosphate binders (PB) are usually prescribed to dialysis patients with hyperphosphatemia. Several studies have reported that higher PB pill burden may reduce adherence and lead to insufficient phosphorus control. Tenapanor is an investigational, minimally absorbed, orally administered, non-binder, small-molecule that inhibits the sodium/hydrogen exchanger isoform 3 (NHE3) in development for the control of serum phosphorus. A previous Ph3 study sponsored by Ardelyx, Inc. (NCT02675998) showed a significant phosphorus decrease compared to the placebo in patients with hyperphosphatemia undergoing hemodialysis (HD) in the US. Tenapanor was expected to reduce PB pill burden since it is administered as one small pill, taken twice a day. This was the first study in Japanese HD patients, which aimed to confirm whether tenapanor reduces the pill burden of PB. Method This was a multicenter, open-label, single-arm Ph2 study. The study consists of a screening period, a 3-week observation period, and a 26-week treatment period. Patients whose serum phosphorus level was ≥ 3.5 and ≤ 7.0 mg/dL, taking at least two PB pills three times a day were enrolled. The patients started to receive 30 mg of tenapanor twice daily. The tenapanor dose could be reduced in a step-wise manner (60, 40, 20 and 10 mg/day) at the investigator’s discretion, based on GI tolerability. PB treatment was continued according to individual regimens, however, the dose could be adjusted appropriately to maintain serum phosphorus level within ±0.5 mg/dL from the baseline. The primary endpoint was an achievement of at least a 30% decrease in the mean of the total number of PB and tenapanor pills compared to the number of PB pills at baseline. The proportion of patients who achieved at least a 30 % decrease were tested using binomial test with a threshold level of 20% and a one-sided significance level of 0.025. The analysis was conducted using the data as of Dec25, 2019. Results The primary endpoint was met. Of 67 enrolled patients at the timing of analysis, 48 patients (71.6%, [95% CI: 59.3% - 82.0%], p&lt;0.001) achieved a 30% decrease in the total number of PB and tenapanor pills, and of those, 35 patients (52.2%, [95% CI: 39.7% - 64.6%]) achieved a 50% decrease and 18 patients (26.9%) no longer required the use of any PB at week 26. Mean phosphorus levels were maintained during the study from 5.2 mg/dL at the baseline to 4.7 mg/dL at week 26. The most frequent adverse event was diarrhea (76.1%), which was mostly mild to moderate. Only four patients discontinued the study due to diarrhea. Serious adverse events were reported in five patients, only two of which were related to tenapanor (diarrhea and acute myocardial infarction). Conclusion Tenapanor was able to provide phosphorus control with significantly fewer pills compared to PB. AE profile was similar to previous US studies. This result suggests that tenapanor, a non-binder, phosphate absorption inhibitor that provides a novel approach to the management of hyperphosphatemia, could potentially improve drug adherence by reducing PB pill burden while maintaining effective phosphorus control.

scholarly journals Correlation between hypophosphatemia and the severity of Corona Virus Disease 2019 patients

2020 ◽  
Author(s):  
Xiaobo Xue ◽  
Jing Ma ◽  
Yuxia Zhao ◽  
Aibin Zhao ◽  
Xiaohong Liu ◽  
...  
Keyword(s):  
Virus Disease ◽  
Common Type ◽  
Serum Phosphorus ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
Absolute Value ◽  
Corona Virus ◽  
Significant Difference ◽  
Critical Patients ◽  
Phosphorus Levels

AbstractObjectiveRetrospectively analyze the clinical data of Corona Virus Disease 2019 (COVID-19) patients and explore the value of serum phosphorus level in evaluating the severity and prognosis of the disease.MethodsCOVID-19 patients transferred from the first emergency ward of Taiyuan fourth people’s Hospital from February 8 to March 3, 2020 were enrolled. The information of general conditions, clinical manifestations, laboratory indexes, nucleic acid detection and treatment were collected. The changes of blood phosphorus level and absolute value of lymphocytes in ordinary and severe/critical patients were recorded and compared.ResultsA total of 32 patients with COVID-19 were collected, including 12 cases of common type and 20 cases of severe/critical type. Before treatment, the serum phosphorus levels of the two groups were significantly lower than the normal level, and the serum phosphorus levels of the severe/critical patients were lower than those of the common type patients (t = 2.767, P < 0.010). After treatment, the serum phosphorus levels of the two groups reached normal, and there was no significant difference between the two groups (t = 0.231, P >0.819). The level of lymphocytes in severe/critical patients was lower than that in normal patients (t = 4.636, P < 0.001) before treatment. After treatment, the absolute value of lymphocytes in the two groups reached normal, and there was no significant difference between the two groups (t=1.208,P=0.237). There was a positive correlation between lymphocytes and serum phosphorus, and the correlation coefficient was 0.479.Conclusionhypophosphatemia is related to the severity of COVID-19, and strengthening the monitoring of serum phosphorus level of COVID-19’s severe/critical patients and correcting hypophosphatemia in time are of significance to improve the prognosis.

Effect of a Dietitian-managed Bone Algorithm on Serum Phosphorus Level in Maintenance Hemodialysis Patients

2013 ◽  
Vol 23 (2) ◽  
pp. 98-105.e2 ◽  
Author(s):  
Debra Blair ◽  
Laura Byham-Gray ◽  
Stephen J. Sweet ◽  
Robert Denmark ◽  
James Scott Parrott ◽  
...  
Keyword(s):  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Maintenance Hemodialysis ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
Maintenance Hemodialysis Patients

scholarly journals Effect of Histamine H2-Receptor Antagonist on the Phosphorus-Binding Abilities of Calcium Carbonate and Calcium Lactate in Hemodialysis Patients

1999 ◽  
Vol 10 (5) ◽  
pp. 1090-1094
Author(s):  
NORIHIRO TAKAHASHI ◽  
TETSUO SHOJI ◽  
KEISUKE MATSUBARA ◽  
HIROFUMI HITOMI ◽  
MAYUKO HASHIMOTO ◽  
...  
Keyword(s):  
Calcium Carbonate ◽  
Hemodialysis Patients ◽  
Calcium Lactate ◽  
Serum Phosphorus ◽  
Phosphorus Level ◽  
Serum Phosphorus Level ◽  
H2 Receptor Antagonist ◽  
Histamine H2 Receptor ◽  
H2 Receptor ◽  
Histamine H2 Receptor Antagonist

Abstract. The effect of histamine H2-receptor antagonist (famotidine) on the phosphorus-binding abilities of calcium carbonate and calcium lactate were examined in 13 chronic hemodialysis patients. In seven patients receiving calcium carbonate, famotidine (20 mg/d) was given because of gastroduodenal disorders, and calcium carbonate was replaced with calcium lactate as a phosphorus binder after 4 wk of treatment with famotidine. With the 4-wk administration of famotidine accompanied by calcium carbonate, the serum phosphorus level increased from 6.3 ± 0.9 to 7.1 ± 0.5 mg/dl (P < 0.05). However, with the substitution of calcium lactate, the serum phosphorus level decreased significantly when compared to that before substitution (6.3 ± 0.2 and 6.0 ± 0.9 mg/dl after 4 and 8 wk of substitution, respectively), despite continued administration of famotidine. Serum calcium, creatinine, alkaline phosphatase, high sensitive parathyroid hormone, blood urea nitrogen, arterial blood pH, and bicarbonate were not significantly altered during the trial period. In six control patients treated with calcium carbonate alone, there were no statistical changes in serum calcium and phosphorus levels after substitution of calcium lactate for calcium carbonate. These results suggest that famotidine significantly affects the phosphorus-binding ability of calcium carbonate, but not that of calcium lactate. A careful observation of changes in the serum phosphorus level should be required in hemodialysis patients receiving calcium carbonate and histamine H2-receptor antagonists. Calcium lactate may be useful as a phosphorus binder in such hemodialysis patients.

scholarly journals Implementation and effectiveness of an intensive education program on phosphate control among hemodialysis patients: a non-randomized, single-arm, single-center trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jinmei Yin ◽  
Jun Yin ◽  
Rongli Lian ◽  
Peiqiu Li ◽  
Jing Zheng
Keyword(s):  
Education Program ◽  
Hemodialysis Patients ◽  
Serum Phosphorus ◽  
Phosphate Binders ◽  
Maintenance Hemodialysis ◽  
Single Center ◽  
Clinical Trial Registry ◽  
Before And After ◽  
Intensive Education ◽  
Phosphate Control

Abstract Background Hyperphosphatemia is a common complication in patients on maintenance hemodialysis. Patients’ adherence to phosphorus control can be improved by consistent education. However, few studies have focused on the model construction and effects of health education on phosphate control for hemodialysis patients. Objective To develop an intensive education program focusing on phosphate control among hemodialysis patients and to analyze the effectiveness of this program. Design A non-randomized, single-arm, single-center trial lasting for 6 months. Setting This program was conducted in a hemodialysis center in a teaching hospital in Zhuhai, China. Participants Patients on maintenance hemodialysis with hyperphosphatemia. Methods An intensive hyperphosphatemia control education program lasting for 6 months was conducted among 366 hemodialysis patients applying the First Principles of Instruction model, which focused on mastering four stages: (a) activation of prior experience, (b) demonstration of skills, (c) application of skills and (d) integration of these skills into real-world activities. The controlled percentage of serum phosphorus, knowledge of hyperphosphatemia, and adherence to phosphate binders before and after the education program were assessed. Results The proportion of controlled serum phosphorus was significantly increased from 43.5 to 54.9% (P<0.001). The scores on the knowledge of phosphate control were improved significantly from 59.0 ± 18.9 to 80.6 ± 12.4 (P < 0.001). The proportion of high adherence to phosphate binders was increased dramatically from 21.9 to 44.5% (P < 0.001). Conclusion The intensive education program can effectively improve serum phosphorus, knowledge of hyperphosphatemia, and adherence to phosphate binders among hemodialysis patients. Trial registration Chinese Clinical Trial Registry, ChiCTR2100042017. Retrospectively registered January 12th, 2021.

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