Patients with chronic kidney disease (CKD) undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at high risk for cardiac surgery associated acute kidney injury (CSA-AKI). Using the primary care CPRD database and linking it with hospital and mortality records, this feasibility study aims to determine the feasibility of determining acute kidney injury among patients undergoing cardiopulmonary bypass procedures and long-term outcomes of CKD progression, dialysis, kidney transplant, mortality, hospitalizations, A&E admissions, and outpatient visits.
If acute kidney injury and renal outcomes are able to be identified in the feasibility study, a future study will be planned to estimate 1) the incidence of AKI following CPB; 2) the demographic and clinical predictors of developing AKI; and 3) the short-term and long-term outcomes of patients who developed and did not develop AKI post-CPB. The future study will identify variables such as age, pre-existing conditions, and procedural factors, which may correlate with the onset of AKI. Furthermore, outcome measures, including subsequent renal function, duration of hospitalization, and mortality, will be analysed to understand the long-term outcomes of AKI post-CPB. The study will help understand the patient journey and medical need of patients experiencing acute kidney injury after CPB procedure in England and Wales.
This feasibility study aims to assess the feasibility of determining acute kidney injury (AKI) and outcomes among patients undergoing surgeries involving cardiopulmonary bypass (CPB) by utilizing the CPRD primary database linked with hospital episode statistics (HES) and ONS mortality data. AKI is recognized for its clinical significance due to its common occurrence post-CPB and its association with increased morbidity and mortality. The CPRD, anonymised primary care records, and linkage with HES facilitates a comprehensive examination of patient medical histories.
Based on CPRD GOLD primary care data of patients undergoing CPB, not limited to patients with CKD from 2010 to 2022 results in 16,411 procedures from 14,036 patients. However, the number of patients with available renal function data (serum creatinine and eGFR) is limited near time of surgery (about 4-6% around the week of surgery) and low numbers of records of dialysis. The protocol seeks to link the CPRD primary care data with the HES and ONS data to assess acute kidney injury and outcomes including CKD progression, dialysis, hospitalizations, and mortality.
For the feasibility study with linked data, descriptive statistics such as mean, standard deviation, interquartile range, minimum, and maximum for the number of events and count and percent for the occurrence of events will be analyzed. Only patients with CKD stage 3 or 4 and without stage 5 or ESRD in the 6 months prior to surgery will be included in the study.
Acute kidney injury; AKI severity; CKD progression; dialysis; kidney transplant; all-cause mortality; hospitalization, A&E admission, outpatient visits.
Kyaw Joe Sint - Chief Investigator - Alexion Pharmaceuticals, Inc ( USA )
Kyaw Joe Sint - Corresponding Applicant - Alexion Pharmaceuticals, Inc ( USA )
Francesca Gatta - Collaborator - AstraZeneca GmbH
HES Accident and Emergency;HES Admitted Patient Care;HES Diagnostic Imaging Dataset;HES Outpatient;ONS Death Registration Data