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Dialysate calcium study in alternate night nocturnal haemodialysis

A randomised controlled trial of high versus low dialysate calcium concentrations to assess aortic calcification and changes in mineral metabolsim in alternate night nocturnal haemodialysis

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000057381
Enrollment
80
Registered
2008-01-30
Start date
2008-02-10
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Elevated calcium phosphate product (Ca x P) is an independent risk factor for vascular calcification and cardiovascular death in the end-stage renal disease (ESRD) population (Block et al, 1998). Conventional haemodialysis (4hrs x 3) may not successfully correct the profound disturbances in calcium and phosphate metabolism of ESRD, characterised by hyperphosphatemia and abnormal serum calcium levels. In general a low calcium dialysate (1.3 mmol/L) is used for patients on conventional haemodialysis in North West Dialysis Service (NWDS), at Monash Medical Centre (MMC) and Geelong Hospital and throughout Australia. The calcium and phosphate balance achieved with Quotidian Nocturnal Haemodialysis (8 hours x 6 days) differs significantly from conventional haemodialysis and is associated with marked improvements in the reduction of elevated serum phosphate levels. An observational study by Lindsay et al demonstrated that patients on quotidian haemodialysis utilising 1.25 mmol/L dialysate calcium exhibited calcium depletion and hypocalcemia thus exacerbating secondary hyperparathyroidism (Lindsay et al, 2003). In the same study they demonstrated that an increase in dialysate calcium concentration was associated with a return of bone alkaline phosphatase levels to baseline and a gradual fall of parathyroid hormone (PTH) levels to target range. In association with the increase in dialysate calcium, the use of activated vitamin D compounds fell. Based on the results of this study, it has been common practice to dialyse all nocturnal haemodialysis patients, regardless of whether they dialyse for 8 hrs x 6 or 8 hrs x 3.5, on higher calcium baths (>1.6 mmol/L). It is not clear however, what should be the optimal calcium bath for patients on 8 x 3.5nights/week, particularly as serum phosphate levels are not as tightly controlled with quotidian haemodialysis, and unlike the 6 nights/week group, many patients still require the use of calcium based phosphate binders. Ideally the optimal calcium bath should be such that the overall Ca x P product is <4mmol2/l2 and the PTH 15-30pmol/l, however the concern is that the use of a higher calcium bath in the alternate night group will lead to relative hypercalcemia and an overall increase in Ca x P. Recent evidence also supports the importance of the pleiotropic effects of Vitamin D in addition to its well-recognised role in bone metabolism. It is conceivable that patients being dialysed with a higher calcium bath may not be able to tolerate the addition of Vitamin D due to the development of hypercalcemia. In order to establish the optimal calcium bath in patients on alternate night haemodialysis, we propose a prospective observational study comparing predefined outcomes using >1.6mmol/L and 1.3mmol/L dialysate calcium.

Interventions

Low dialysate calcium bath (1.3mmol/L) administered during haemodialysis (alternate nightly) for 12 months

Sponsors

Monash Medical Centre
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Subjects receiving renal replacement therapy in the form of haemodialysis at home, alternate night nocturnal haemoialysis (NHD) (3.5nights/week) Subjects must be 18-80 years of age Willingness to provide written informed consent

Exclusion criteria

Subjects unable to give informed consent or whom have an expected life-span of less than 3 months Subjects already scheduled to have a kidney transplant from a known living donor

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026