Infraestructura de Medicina de Precisión asociada a la Ciencia y la Tecnología
The NATIONAL NETWORK OF RENAL FUNCTION LABORATORIES project aims to offer a solution to a serious problem in clinical medicine in 2022: the error of the formulas for estimating kidney function and its consequences. Different studies have shown that estimation formulas, whether those that use creatinine, cystatin-c or both, have a wide, frequent and random error when estimating the renal function of patients. The magnitude of the error speaks for itself: the average variability of any equation is +/- 30% of actual kidney function, when measured by reference standards. This variability may not be relevant in subjects in the general population, or in subjects without kidney disease. However, error in estimation formulas in patients with chronic kidney disease (both adults and children) or in subjects in whom reliable measurement is needed to make clinical decisions can have important consequences. However, the alternative to formulas, i.e. methods of measuring kidney function with reference standards (inulin, DTPA, iohexole, iothalamate) are complex and laborious techniques. Therefore, clinical medicine is at a crossroads, measuring kidney function assuming the complexity of the method or estimating and assuming errors and the effects derived from them. In the present project – following the lines of PRECISION MEDICINE – we propose the use of iohexol clearance using dry chemistry (iohexol-DBS) as a simple, reliable, economical and realistic alternative to measure kidney function in a specific group of cases: clinical conditions where it is crucial to have a reliable assessment of kidney function. The iohexol-DBS is a simplification of the method developed and validated by the Renal Function Laboratory of the ULL (LFR-ULL). In this laboratory, the method is performed on patients with chronic kidney disease, adults and children, donors of the living donor program, kidney transplant recipients and subjects in whom a potentially toxic medication needs to be adjusted according to the renal filtration.
Our goal is for 9 Spanish centers to each have an LFR, in order to provide this technique to patients in whom it is necessary to have an accurate value of renal function. The LFR-ULL will instruct the centres, they will be provided with the necessary training support as well as the necessary computer programs to assemble and develop the method. In addition, a regular validation system will be organised between the centres and the LFR-ULL.
The main objective of the project is to:
The main objective of the project is to assess the technical and economic feasibility of implementing renal function measurement in the daily clinic with a simplified method, iohexol-DBS. With this method, a more precise and accurate assessment of the renal function of patients will be obtained, following the precepts of personalized or precision medicine.
The secondary objectives of the project are:
Considering the widespread and unpredictable error of the methods for estimating kidney function in use today in clinical practice, the consortium has predicted that the impact of implementing a much more reliable method within the NHS will be high, relevant and predictable. The most important aspects of the expected impact of the project are highlighted:
I.- In the field of population health: a more precise and accurate method – and at the same time simple and practical – to measure kidney function will have multiple advantages at the level of different risk populations, such as:
II.- In the field of the NHS. CKD is among the most expensive diseases for healthcare systems, costing an estimated €140 billion annually in Europe. According to a report by the European Parliament, there are still many challenges to overcome before we can reverse this worrying trend. Most patients with CKD are unaware of their status due to the lack of early diagnosis. A method such as the one proposed to be implemented in this project, more precise and accurate, will make the NHS more effective in clinical decision-making, diagnosis, treatment and prevention in a disease as common as CKD. On the other hand, it should be borne in mind that CKD has a very high health cost in Spain, as important as that of cancer or diabetes: 1108 million euros per year. Improving the accuracy in the aforementioned aspects, with a simple and low-cost method such as iohexol-DBS, will mean savings in direct and indirect costs derived from diagnostic and prognostic improvements in CKD and other clinical conditions.
III.- Social impact: In Europe, a staggering 75 million people suffer from CKD, while the global frequency has been estimated between 700 and 800 million people, with a projection that CKD will become the fifth leading cause of death worldwide by 2040. In Spain, it affects around 10% of the Spanish population. Predictive studies have observed that the prevalence and incidence of CKD and its consequences will increase in the coming decades, and may become the 5th leading cause of death in Spain by 2040.
The COVID-19 outbreak has made the situation even worse. Recent data shows that patients with CKD are at higher risk than those with other known risk factors, including chronic heart and lung disease. Mortality rates are worryingly high: 20% in kidney transplant recipients and 21% in dialysis patients. In addition, acute kidney injury (AKI) has been reported to affect 58% of hospitalized COVID-19 patients with an associated mortality rate of more than 30%. Since many AKI patients subsequently develop CKD, COVID-19 patients who survive AKI are likely to experience the same course and increase the overall burden of CKD in Europe.