A two-phase Study of Longitudinal Ordinal Outcome Data in Critically Ill Patients with Sepsis

Oregon Convention Center 

The Crystalloid Liberal or Vasopressor Early Resuscitation in Sepsis (CLOVERS) trial was a randomized trial comparing the two fluid resuscitation strategies in patients with sepsis. The trial recruited 1,563 people and, over the course of 14 days, collected daily outcome information on patients' (ordered) outcome states: discharged, hospitalized, intensive care unit, or not alive. For every patient, blood samples were collected at recruitment in the trial and stored for secondary studies. We are interested in the design and analysis for a secondary study of the association of syndecan-1 concentrations (a biomarker capturing glycocalyx degradation) at baseline and ordered states data over time. Due to budgetary constraints, researchers could retrospectively measure the biomarker in 600 out of the 1563 recruited patients. We will discuss consideration for identifying whom to sample using available data, and then how to analyze the sample so that results generalize, and so that analyses get as much information out of the data as possible.