Ionised and Adjusted Calcium Levels in Stable Haemodialysis Patients

• Research type

  Research Study

• Full title

  Calcium Levels in Stable Haemodialysis Patients: The Ionised Fraction and Effects of Adjustment/Albumin Assays

• IRAS ID

  314739

• Contact name

  Osama Eisa

• Contact email

  osama.eisa@nhs.net

• Sponsor organisation

  Leeds Teaching Hospitals NHS Trust

• Duration of Study in the UK

  0 years, 6 months, 0 days

• Research summary

  Accurate assessment of serum calcium is crucial for the management of patients with Chronic Kidney Disease (CKD), especially those undergoing regular haemodialysis. It has been found that delay in treating calcium that is either too high or too low in patients on haemodialysis can contribute to heart attacks, strokes and even death.
  
  As calcium is mainly bound to albumin (a major serum protein) in the blood, clinical laboratories usually report measurements of serum calcium after taking into account the albumin level. This is done via a general calcium adjustment equation which is not specific to haemodialysis patients. This practice has many limitations and several researchers have described inherent problems of this concept especially in the context of long-term haemodialysis.

  Furthermore, albumin concentrations are usually measured in laboratories using dye-binding methods- either a purple or green dye [modified” Bromocresol Purple (mBCP) or Bromocresol Green (BCG)]. These dye methods are simple and adapted to high volume testing. However, they are not as accurate when compared to the reference method and this decline in accuracy is even more pronounced in the context of patients with CKD.

  We intend to formulate and test a CKD-specific calcium adjustment equation by gathering blood samples from haemodialysis patients from May 2022. We will also be able to compare the dye albumin methods to assess their accuracy in producing adjusted calcium results against the gold standard ionised-calcium results.

  We will recruit adult patients with end-stage CKD attending the haemodialysis units at Leeds Teaching Hospitals Trust. The main determinant for the length of the study is the collection of blood samples from a minimum of 100 subjects. A single donation of (1 x 5 ml and 1 x 2.5 ml blood tubes) per participant is required.

• REC name

  West Midlands - Solihull Research Ethics Committee

• REC reference

  22/WM/0130

• Date of REC Opinion

  31 May 2022

• REC opinion

  Favourable Opinion