Clinical Trials Spotlight— Department of Medicine

OPTIMIZE-GNI (Infectious Diseases). Although medications like antibiotics are important weapons for fighting illness, they can have unwanted side effects. For example, two antibiotics used to treat antimicrobial-resistant gram-negative infections (meropenem and cefepime) can decrease kidney function in some patients.

The ‘gold standard’ method for assessing kidney function involves using iohexol as a marker, but some patients have allergic reactions to this compound. As a potential alternative, the OPTIMIZE study is investigating cystatin (Cys-C), a normal protein produced by cells in the body and released into the bloodstream. The goal of the OPTIMIZE study is to show that, in terms of estimating kidney function, using calculations based on Cys-C is at least as accurate as using those involving iohexol. Having accurate information about patients’ kidney function helps physicians to tailor patients’ treatment plans to minimize side effects and maximize therapeutic benefit.

Persons eligible to participate in OPTIMIZE include adult (≥18 years old) ICU patients who receive meropenem or cefepime as part of their clinical management. Participants will receive iohexol on day 1 of the study. During the study period (2 or 3 days for each participant), a total of 12 blood samples will be collected for research purposes. The amounts of iohexol and Cys-C in these samples will be determined and used to calculate kidney function. The accuracy of the Cys-C method will be compared with that of the standard (iohexol) method. For more information about OPTIMIZE-GNI, click here.