West Midlands Guidelines for managing
CKD Mineral and Bone Disorders in
Haemodialysis Patients
http://www.wmrn.co.uk/admin/resources/uploads/WM%20MDB%20Haemodialysis%20Guidelines.pdf
Background
• West Midlands Audit Oct 2006
• Presented West Midlands Audit Meeting 2007
• Highlighted significant variation in practice and
achievement of targets across the region
Audit: key conclusions
• Discrepancies between dietitians and clinicians within
units:
– Target ranges
– Upper levels of intervention
– 1st line intervention
– Frequency in changes to medication
– Standard Dialysate used
• Variation found across units in the ranges and standards
used but majority of units following:
– PO4 <1.8mmol/l (RAS)
– CrCa 2.2- 2.6mmol/l (RAS)
– PTH 4XULN(RAS)
– CaxPO4 <4.7
% PATIENTS ACHIEVING PHOSPHATE LEVEL OF <1.80mmol/l
100.00
90.00
PERCENTAGE OF PATIENTS
80.00
70.00
60.00
50.00
83.00
40.00
30.00
20.00
43.00
10.00
0.00
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
TOTAL UNITS
Wide range in PO4 control across the units (range between 42-76%)
% OF PATIENTS ACHIEVING PTH LEVEL OF 150-300ng/L ( KDOQI)
PTH 150-300
100.00
PTH > 300
PTH < 150
90.00
80.00
PERCENTAGE OF PATIENTS
70.00
60.00
50.00
40.00
30.00
20.00
10.00
14.00
20.00
22.00
25.00
20.00
24.00
18.00
2
3
4
5
6
7
0.00
1
SATELITTE AND BASE UNITS COMBINED
WM Renal Network identified need to develop
regional guidelines to standardise practice
across the region.
Steering Group
Trust
Steering Group Dietitian
Steering Group Nephrologist
HEFT (co-chairs)
Jo Martin
Dr Indranil Dasgupta
UHB
Emma Taylor
Dr Fouad Al-Baaj
Coventry & Warwickshire
Beverley Beynon-Cobb /
Caroline Bird
Dr Daniel Zehnder
Dudley Group of Hospitals
Christine Morgan
No Nephrologist
North Staffordshire
No Dietitian
Dr Dominic De-Takats
Royal Shrewsbury Hospitals
Sylvia Grace
No Nephrologist ( Dr Kevin
Eardley aware of process)
Royal Wolverhampton Hospitals
No Dietitian
Dr Johann Nicholas
Dudley PCT Pharmacuetical Advisor
Clair Huckerby
West Midlands Renal Network
Nanette Grant
The process
• 1st meeting Nov 2008
• Subsequent meetings on Jan 09, May 09, July 09, Sept 09,
March 10, Oct 10
• Conducted a West Midlands Renal Dietetic Staffing Survey
• Evidence review (Before KDIGO) on:
– Calcium Content of Dialysis Fluid
– Elemental Calcium content of binders
– PTH levels and starting dose of vitamin D
– PTH Assay
– Vascular Calcification in Diabetics
– Vitamin D monitoring and supplementation
• Review of RAS and KDIGO Guidelines / Renal Registry Data
• Invited Expert: Dr Alan Jones, Biochemist re: PTH Assay,
Vitamin D monitoring and Bone Alkaline Phosphatase
Good Practice Recommendations
1.
2.
3.
4.
5.
6.
7.
8.
9.
Dietetic referrals
Dialysis adequacy
Phosphate target and dietetic input
Corrected calcium target
PTH assays, target, unit
Dialysis fluid Ca concentration
Phosphate binders
Indications for using Ca and non-Ca binders
Pharmacological treatment with active vitamin D
compounds
10. Treatment of severe uncontrolled SHPT
Guideline 3: Phosphate
Good practice recommendation:
Patients with a serum phosphate level > 1.4mmol/l
should be referred to a Renal Dietitian
All patients should have their serum phosphate levels
maintained <1.6mmol/l with adequate dialysis, dietary
modification and/or use of phosphate binders.
Treatment changes should be made taking into account
trends in levels rather than individual measurements
Guideline 5: Parathyroid Hormone (PTH)
Good practice recommendation:
PTH should be monitored at least 3monthly and treatment changes should
be based on trends of serum PTH rather than a single measurement.
Changes in serum phosphate, corrected calcium and alkaline phosphatase
levels should be taken into consideration when making treatment changes.
Raised alkaline phosphatase levels in the absence of evidence of liver disease
would suggest high bone turnover.
PTH levels should be maintained within 2-9 times of upper limit of laboratory
reference range.
The group acknowledge that it is not logistically feasible to standardise PTH
assay across the region.
Laboratories should express PTH values in pmol/L to enable comparison
between units for audit purposes. However, we need to recognise that there
remains variability between assays.
Patients on Paricalcitol and Cinacalcet need more frequent monitoring of PTH
levels particularly following initiation or changes to treatment.
Guideline 6: Dialysis fluid Calcium Concentration
Good Practice Recommendation:
To use standard dialysis fluid calcium concentration of
1.5mmol
To use dialysis fluid calcium concentration of 1.25mmol
for patients with adynamic bone disease (ADBD),
evidence of vascular calcification or hypercalcaemia
To use dialysis fluid calcium concentration of 1.75mmol
for patients with hypocalcaemia.
Implementation
• Endorsed by WM Renal Network in September 2010
• Circulated to all Clinical Directors across West
Midlands in November 2010
• Steering Group Unit representative to lead
implementation within unit
• To re-audit in 2012
Proposed key changes
(take home message)
• Phosphate target: < 1.6mmol/l
• PTH:
– 2-9 times ULN
– change expression to pmol/l
– which will equate to target range of 15-68pmol/l
– Change to 3 monthly monitoring
• Change standard calcium dialysate to 1.5mmol/l
West Midlands Guidelines for managing
CKD Mineral and Bone Disorders in
Haemodialysis Patients
http://www.wmrn.co.uk/admin/resources/uploads/WM%20MDB%20Haemodialysis%20Guidelines.pdf
Proposed local changes
• Phosphate target: < 1.6mmol/l
• PTH:
– 2-9 times ULN
– change expression to pmol/l
– which will equate to target range of 15-68pmol/l
– Change to 3 monthly monitoring
• Change standard calcium dialysate to 1.5mmol/l
• (Lateral abdominal x-ray on new HD patients to assess for
vascular calcification)
• (Monitor 25- hydroxyvitamin D (25(OH)D) levels)
Guideline 1: Dietetic Referral
Good Practice Recommendation:
All patients with CKD Stage 4 and with a serum phosphate
level > 1.4mmol/l should be referred to a Renal Dietitian for a
full dietary assessment
Good Practice Recommendation:
Renal Dietetic staffing levels should be based on the BRS
Renal Workforce Planning Recommendations 2002 which
state:
o
o
o
o
1WTE per 135 haemodialysis patients
1WTE per 180 low clearance patients
1 WTE per 270 peritoneal patients
2 WTE per 28 bedded ward
Guideline 2: Dialysis Adequacy
Good Practice Recommendation:
Minimum haemodialysis hours should be based on 4hours x
3times per week
In relation to phosphate control, urea reduction ratio (URR)
should be maintained > 65% and/ or equilibrated Kt/V should
be maintained >1.2
Guideline 4: Corrected Calcium
Good practice recommendation:
Pre-dialysis serum calcium, adjusted for serum albumin,
should be within the normal laboratory reference range
Treatment changes should be made taking into account trends
in levels rather than individual measurements
Guideline 7: Phosphate Binders
Good Practice Recommendation:
Phosphate Binder should be started when phosphate
levels ≥ 1.6mmol/l despite adequate dialysis and
dietary modification
Guideline 8a:
Calcium Containing Phosphate Binder
Good Practice Recommendation:
The choice of phosphate binder should be individualised,
depending on clinical circumstances.
In comparison to calcium carbonate, calcium acetate has
a higher binder capacity per mg elemental calcium and
it’s action is less pH dependant (Sheikh et al 1989)
Calcium carbonate may be less effective with used with
inhibitors of gastric acidity e.g. proton pump inhibitors.
Guideline 8c:
Non-Calcium Containing Phosphate Binder
There is insufficient evidence to recommend any one noncalcium binder over another
Good Practice Recommendation:
Starting any binder should be at the clinician’s discretion and
should take into account all relevant patient factors.
Guideline 8d: Aluminium Hydroxide
Good Practice Recommendation:
Aluminium hydroxide should be used as last resort
and for a limited period of 3 months; further use will
be at the clinician’s discretion.
Guideline 8b: Elemental calcium content of
Phosphate Binders
There is insufficient evidence to make a recommendation
limiting the oral calcium from diet or binders.
Good Practice Recommendation:
An individualised strategy to limit the total calcium intake
should be in place for patients:
o on higher dialysis fluid calcium concentration (>1.5mmol/l)
o with pre-existing vascular calcification or at risk of vascular
calcification (e.g. diabetics). A lateral abdominal x-ray can be
used to assess vascular calcification.
o with elevated serum calcium levels
o with low serum PTH levels
Guideline 9: Pharmacological treatment with active
vitamin D compounds
There is insufficient evidence to recommend either calcitriol or alfacalcidol as the first line vitamin D
therapy. The group felt that as alfacalcidol is a prodrug, calcitriol should be used in preference.
There is insufficient evidence to make a recommendation on the starting dose of calcitriol or alfacalcidol
based on PTH levels.
Good Practice Recommendation:
Commence calcitriol or alfacalcidol at the lowest dose and titrate according to serum calcium and
subsequent PTH values.
Aim to maintain corrected calcium within the normal laboratory reference range and phosphate levels ≤
1.6mmol/l.
Paricalcitol should be considered on patients with high serum PTH levels and a serum calcium level at the
upper level of the normal reference range despite maximum oral or intravenous active vitamin D therapy.
Good Practice Recommendation: Monitoring and supplementing 25- hydroxyvitamin D (25(OH)D) to
counteract vitamin D insufficiency.
It is reasonable to identify vitamin D deficiency among dialysis patients and if levels ≤ 75nmol/l to give
supplementation with the view of achieving levels ≥ 75nmol/l.
It is reasonable to identify vitamin D deficiency among dialysis patients and give supplementation with
vitamin D3 (cholecalciferol) or vitamin D2 (ergocalciferol) as a single substance not combined with calcium
or other vitamins.
Vitamin D supplementation should not be confused with calcitriol or alfacalcidol treatment.
Guideline 10:
Treatment of uncontrolled severe secondary
hyperparathyroidism.
Good Practice Recommendation:
For patients who are fit for surgery, total parathyroidectomy without reimplantation should be considered as treatment for persistent severe
secondary hyperparathyroidism (PTH levels > 9 times upper limit of
normal reference range) despite maximum medical therapy and clinical
evidence of morbidity in association with this. In the presence of
calciphylaxis parathyroidectomy should be considered in patients with
lower PTH levels.
Cinacalcet should be considered in patients with persistent severe
secondary hyperparathyroidism who are high surgical risk for
parathyroidectomy in accordance with the NICE guidelines. Cinacalcet
should also be considered in such patients who are fit for surgery but for
whom surgery is not immediately available for whatever reason.