Effect of Dialysate Calcium Concentrations on Parathyroid Hormone and Calcium Balance During a Single Dialysis Session Using Bicarbonate Hemodialysis: A Crossover Clinical Trial

Basile, Carlo; Libutti, Pasquale; Turo, Anna Lucia Di; Vernaglione, Luigi; Casucci, Francesco; Losurdo, Nicola; Teutonico, Annalisa; Lomonte, Carlo

doi:10.1053/j.ajkd.2011.08.033

Cited by 53 publications

(63 citation statements)

References 17 publications

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“…The post hoc exploratory analyses revealed that cinacalcet was nominally more effective than vitamin D analogs in reducing PTH levels when participants were also concomitantly treated with dialysate calcium $2.5 mEq/L or calcium-based phosphate binders. Exposure to low dialysate calcium concentrations has been shown to result in acute reductions in ionized calcium levels and increases in intradialytic PTH levels (24). Conversion from dialysate calcium concentrations of 2.5 mEq/L to lower levels was shown to be associated with worsening of SHPT despite treatment intensification (25).…”

Section: Discussionmentioning

confidence: 99%

A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM)

Wetmore

Gurevich²,

Sprague

et al. 2015

Clinical Journal of the American Society of Nephrology

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Background and objectives Direct comparison of cinacalcet and vitamin D analogs as monotherapies to lower parathyroid hormone (PTH) levels has not been undertaken.Design, setting, participants, & measurements This was a prospective, multicenter, phase 4, randomized, openlabel study that enrolled participants from 2010 to 2012. Adult participants (n=312) on hemodialysis with PTH .450 pg/ml were randomized 1:1 to 12 months of treatment with either cinacalcet (n=155) or vitamin D analogs (n=157) to evaluate the mean percentage change in plasma PTH level (primary end point) and the proportion of participants achieving plasma PTH ,300 pg/ml or a $30% decrease in PTH (secondary end points). A preplanned analysis to determine whether there were important region-by-treatment interactions was also undertaken.Results Baseline mean PTH was 846 pg/ml (n=155) for cinacalcet and 816 pg/ml (n=157) for vitamin D analog therapy. The mean (95% confidence interval) percentage change from baseline in PTH was 212.1% (220.0% to 24.1%) in the cinacalcet arm and 27.0% (214.9% to 0.8%) in the vitamin D analog arm, a difference of 25.0% (215.4% to 5.4%) (P=0.35). Similarly, there was no difference in achievement of secondary efficacy end points between arms (19.4% and 15.3% of participants with PTH#300 pg/ml and 42.6% and 33.8% of participants had a PTH reduction .30% in the cinacalcet and vitamin D analog arms, respectively). A prespecified analysis revealed a large treatment-by-region interaction, with nominally greater response to cinacalcet compared with vitamin D analogs in non-United States participants (US versus non-US participants, P,0.001). Hypocalcemia was more common in the cinacalcet arm, whereas hypercalcemia and hyperphosphatemia occurred more often in the vitamin D analog arm.Conclusions Participants had similar modest reductions in PTH with either cinacalcet or vitamin D analog monotherapy over 52 weeks of treatment, but effects varied by region. Treatments differed with regard to effect on calcium and phosphorus levels.

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Section: Discussionmentioning

confidence: 99%

A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM)

Wetmore

Gurevich²,

Sprague

et al. 2015

Clinical Journal of the American Society of Nephrology

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“…On average, calcium balance is almost neutral calcium balance with 2.5 mEq/l dialysate calcium and may be up to 500 mg/session positive with 3.0 mEq/l dialysate [calcium] when dialysis and enteral sources of calcium are considered [12,16,17]. Up to 70% of patients using calcium-based phosphate binders and 20-50% of those not using these binders would require 2.5 mEq/l dialysate [calcium] to prevent a positive calcium balance [11].…”

Section: Discussionmentioning

confidence: 99%

“…However, 2.5 mEq/l dialysate [calcium] has worse hemodynamic tolerance and may aggravate hyperparathyroidism. A dialysate [calcium] of 2.75 mEq/l has been suggested to be optimal, as it is associated with a mild positive calcium balance, and does not stimulate PTH release [16]. The type of dialysis influences the choice of the dialysate [calcium], as calcium lost by convective transport may depend on ultrafiltration and even exceed the amount of calcium gained by diffusion [27,28].…”

Section: Discussionmentioning

confidence: 99%

Individualization of Dialysate Calcium Concentration According to Baseline Pre-Dialysis Serum Calcium

et al. 2014

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Background: A positive calcium balance may contribute to vascular calcification, while a negative balance increases iPTH. We explored the impact of different dialysate calcium concentrations on bone and mineral metabolism parameters according to pre-dialysis serum calcium levels. Results: Fifty-six hemodialysis patients were dialyzed with 3.0 or 2.5 mEq/l dialysate [calcium] in a crossover study of two weeks. Bone mineral metabolites were measured prior to and following the hemodialysis session. A 3.0 mEq/l dialysate [calcium] increased more post-dialysis total calcium and ionized calcium than 2.5 mEq/l dialysate [calcium]. The mildest dialysis-induced changes in calcium and PTH were observed in patients with pre-dialysis serum calcium <8.75 mg/dl dialyzed with 2.5 mEq/l dialysate [calcium] and in patients with pre-dialysis serum calcium >9.15 mg/dl dialyzed with 3.0 mEq/l calcium dialysate. Conclusion: In conclusion, the individualization of dialysate calcium concentration according to baseline pre-dialysis serum calcium may prevent major excursions in post-dialysis serum calcium and iPTH levels. Short Summary: High calcium dialysate may increase serum calcium in hemodialysis patients, while low dialysate calcium may increase PTH. Individualization of dialysate calcium according to predialysis serum calcium levels may prevent or decrease unwanted excursions of both serum calcium and PTH.

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“…Jean et al [18] reported that increasing DCa from 1.25 to 1.5 mmol/l and from 1.5 to 1.75 mmol/l led to a significant increase of calcemia and a decrease of phosphatemia, total ALP (tALP) and PTH. Decreasing DCa from 1.75 to 1.5 mmol/l and from 1.5 to 1.25 mmol/l led to a decrease of calcemia and an increase of phosphatemia, tALP and PTH in 78 patients [19]. Basile et al [19] in the study of hourly measurements of plasma iCa and PTH concentrations and tCa mass balances from the dialysate side in 22 HD patients showed that hourly plasma iCa concentrations were higher with a dialysate tCa concentration of 3.0, 2.75 and 2.5 mEq/l (p < 0.05) as were iCa concentrations at the end of dialysis sessions.…”

Section: Discussionmentioning

confidence: 99%

“…Decreasing DCa from 1.75 to 1.5 mmol/l and from 1.5 to 1.25 mmol/l led to a decrease of calcemia and an increase of phosphatemia, tALP and PTH in 78 patients [19]. Basile et al [19] in the study of hourly measurements of plasma iCa and PTH concentrations and tCa mass balances from the dialysate side in 22 HD patients showed that hourly plasma iCa concentrations were higher with a dialysate tCa concentration of 3.0, 2.75 and 2.5 mEq/l (p < 0.05) as were iCa concentrations at the end of dialysis sessions. Mean tCa mass balance values (diffusion gradient from the dialysate to the patient) were positive with all dialysate tCa concentrations and increased progressively with dialysate tCa concentration.…”

Section: Discussionmentioning

confidence: 99%

The Study of Low Calcium Dialysate on Elderly Hemodialysis Patients with Secondary Hypoparathyroidism

Xiong

et al. 2016

Blood Purif

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Objective: The study aimed to study the safety and efficacy of 1.25 mmol/l calcium dialysate on maintenance hemodialysis (MHD) in elderly patients who suffered from secondary hypoparathyroidism. Methods: Eighty-two elderly patients (ages ≥65) who had been in MHD with dialysate calcium at 1.5 mmol/l over 6 months and had 2 consecutive serum intact parathyroid hormone (iPTH) measurements at level below 100 pg/ml were selected and randomized into 2 groups: treatment group (41 patients, with dialysate calcium at 1.25 mmol/l) and control group (41 patients, still with dialysate calcium at 1.5 mmol/l). Both groups were studied for the duration of 12 months. The changes of serum iPTH, calcium, phosphorus, calcium and phosphorus product and other indicators as well as related adverse reactions were recorded at the following time points: before the study and 1, 3, 6 and 12 months into the study. In addition, the intimal media thickness (IMT) of carotid artery and abdominal aorta calcification score (AACS) were measured in the 0, 6 and 12 months during the study. Results: (1) In the treatment group, the levels of serum corrected calcium, phosphorus and calcium-phosphate product began to decline after 1 month and exhibited further decrease 3 months later. Serum iPTH level increased significantly after 1 month into the study and the trend continued. The above markers stabilized after month 6. Compared with pre-study markers, the changes of the above markers were significant after study (p < 0.05). (2) The average IMT and AACS were evidently decreased during the 6 and 12 months of study in the treatment group. There was statistical significance (p < 0.05) when compared with the above indexes of the pre-study and the control group. (3) In the control group, there were no significant differences in above laboratory markers over the 12-month study period. (4) There was no significant difference in the adverse events observed between the 2 groups. Conclusion: Safety of low calcium dialysate (dialysate calcium 1.25 mmol/l) in elderly MHD patients with iPTH <100 pg/ml is good, as well as improving carotid IMT, resistance index and AACS as indexes of vascular calcification in the small study group and warrants further investigation.

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Effect of Dialysate Calcium Concentrations on Parathyroid Hormone and Calcium Balance During a Single Dialysis Session Using Bicarbonate Hemodialysis: A Crossover Clinical Trial

Cited by 53 publications

References 17 publications

A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM)

A Randomized Trial of Cinacalcet versus Vitamin D Analogs as Monotherapy in Secondary Hyperparathyroidism (PARADIGM)

Individualization of Dialysate Calcium Concentration According to Baseline Pre-Dialysis Serum Calcium

The Study of Low Calcium Dialysate on Elderly Hemodialysis Patients with Secondary Hypoparathyroidism

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