Clinical Study Design and Technical Support for Risk Factors for Cardiovascular Disease, Including Infection/Sepsis[Confidential Commercial Client]
TTi has been under contract for three years with a confidential commercial client to conduct studies and analyses of risk factors and interventions related to cardiovascular outcomes in the maintenance of hemodialysis patients. As part of a multi-disciplinary team, TTi epidemiologists and biostatisticians have worked with clinical experts to better understand the causes of adverse cardiovascular outcomes in this highly vulnerable patient population. The ongoing scientific support contract has involved a broad range of tasks including the conduct of systematic reviews and weight-of-evidence analyses and preparation of technical briefing documents and presentations on topics such as: mechanisms of acid-base imbalance in CKD patients; the relationship between nutrition and patient outcomes in CKD patients; hypokalemia and sudden cardiac death; infection and sepsis as risk factors for adverse cardiovascular outcomes; and statistical approaches to the analysis of serum biomarkers in CKD patients, among others. The TTi Team is currently involved in a re-analysis of a proprietary clinical database of dialysis-dependent CKD patients aimed at investigating associations between clinical practice parameters and patient characteristics and adverse patient outcomes.