Development and validation of risk prediction equations and the burden of Hyperkalemia: a retrospective cohort study using routinely collected clinical practice data

Study type
Protocol
Date of Approval
Study reference ID
16_223
Lay Summary

Hyperkalemia is the presence of elevated (>5 mmol/L) potassium concentration in the blood. It is associated with conditions in which the body’s ability to regulate renal potassium is impaired, including diabetes, heart failure and chronic kidney disease (CKD). Other common causes of hyperkalemia include increased intake of potassium and the use of certain medicines, such as treatments for chronic kidney disease that interfere with the renin-angiotensin-aldosterone system, and the combination of angiotensin converting enzyme inhibitors and spironolactone in patients with chronic heart failure (HF).

The specific objectives of this study are to utilize routine clinical practice data, from the Clinical Practice Research Datalink (CPRD), and secondary care data, from the Hospital Episode Statistics (HES) database, to characterize the frequency of hyperkalemia episodes and evaluate patterns of outcomes (for example, mortality, morbidity, length of stay, discontinuation of medicines) in the UK in subjects with HF or CKD, with/without diabetes. This data will additionally be used to evaluate the validity of existing published risk equations (derived from routine healthcare data in the US) to the European context, and to develop UK-specific risk equations that relate clinical and demographic factors (including potassium concentration) to the risk of morbidity, mortality and hospitalization associated with hyperkalemia.

Technical Summary

Hyperkalemia is a serious medical condition that is associated with increased risk of death and hospitalization. The risk of cardiac-related morbidity and mortality is especially elevated, as hyperkalemia can cause severe alterations to cardiac electrophysiology.

In the European context, the natural history and burden of hyperkalemia from the perspective of routine clinical data is not well characterized and studies are largely from the US. Given the relative paucity of European data, and opportunity to utilize US based research that describes the real-world outcomes in patients with/without hyperkalemia, the specific objectives of this research are to utilize routine CPRD and secondary care (HES) data to characterize the natural history and burden of hyperkalemia in the UK, in patients with CKD or HF, with/without diabetes.

We also seek to evaluate the validity and generalizability of existing published risk equations when applied to European data, and to develop, where feasible, UK-specific risk equations that relate clinical and demographic factors (including serum potassium) to the risk of morbidity, mortality and hospitalization associated with hyperkalemia.

Health Outcomes to be Measured

Hyperkalemia is a serious medical condition that is associated with increased risk of death and hospitalization. The risk of cardiac-related morbidity and mortality is especially elevated, as hyperkalemia can cause severe alterations to cardiac electrophysiology. In the European context, the natural history and burden of hyperkalemia from the perspective of routine clinical data is not well characterized and studies are largely from the US. Given the relative paucity of European data, and opportunity to utilize US based research that describes the real-world outcomes in patients with/without hyperkalemia, the specific objectives of this research are to utilize routine CPRD and secondary care (HES) data to characterize the natural history and burden of hyperkalemia in the UK, in patients with CKD or HF, with/without diabetes. We also seek to evaluate the validity and generalizability of existing published risk equations when applied to European data, and to develop, where feasible, UK-specific risk equations that relate clinical and demographic factors (including serum potassium) to the risk of morbidity, mortality and hospitalization associated with hyperkalemia.

Collaborators

Phil McEwan - Chief Investigator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Phil McEwan - Corresponding Applicant - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Jason Gordon - Collaborator - Health Economics & Outcomes Research Ltd ( HEOR Ltd )
Marc Evans - Collaborator - Llandough Hospital
Qin Lei - Collaborator - Astra Zeneca Inc - USA
Susan S Grandy - Collaborator - Astra Zeneca Inc - USA

Linkages

HES Admitted Patient Care;ONS Death Registration Data