ICU‐free days as a more sensitive primary outcome for clinical trials in critically ill pediatric patients

Abstract

Background Our objective was to assess the association between intensive care unit (ICU)‐free days and patient outcomes in pediatric prehospital care and to evaluate whether ICU‐free days is a more sensitive outcome measure for emergency medical services research in this population. Methods This study used data from a previous pediatric prehospital trial. The original study enrolled patients ≤12 years of age and compared bag‐valve‐mask‐ventilation (BVM) versus endotracheal intubation (ETI) during prehospital resuscitation. For the current study, we defined ICU‐free days as 30 minus the number of days in the ICU (range, 0–30 days) and assigned 0 ICU‐free days for death within 30 days. We compared ICU‐free days between the original study treatment groups (BVM vs ETI) and with the original trial outcomes of survival to hospital discharge and Pediatric Cerebral Performance Category (PCPC). Results Median ICU‐free days for the BVM group (n = 404) versus ETI group (n = 416) was not statistically different: 0 ICU‐free days (interquartile range, 0–10) versus 0 (0–0), P = 0.219. Median ICU‐free days were greater for BVM group in 3 subgroups: foreign body aspiration 30 (0–30) versus 0 (0–21), P = 0.028; child maltreatment 0 (0–14.2) versus 0 (0‐0), P = 0.004; and respiratory arrest 25 (1–29) versus 7.5 (0–27.7), P = 0.015. In the original trial, neither survival nor PCPC demonstrated differences in all 3 subgroups—survival was greater with BVM for child maltreatment and respiratory arrest and favorable PCPC was greater with BVM for foreign body aspiration. Overall, in the current study, patients with more ICU‐free days also had greater survival to hospital discharge and more favorable PCPC scores. Conclusions This initial study of the association between ICU‐free days and patient outcomes during prehospital pediatric resuscitation appears to support the use of ICU‐free days as a clinical endpoint in this population. ICU‐free days may be more sensitive than either mortality or PCPC alone while capturing aspects of both measures.

A targetable ‘rogue’ neutrophil-subset, [CD11b+DEspR+] immunotype, is associated with severity and mortality in acute respiratory distress syndrome (ARDS) and COVID-19-ARDS

“…5 A, Table 1 ). To assess clinical severity, we studied the number of ICU-free days at day 28 from ARDS diagnosis as a measure of mortality (death scored as [-1]) and speed to recovery within 28-days 39 , ARDS severity (SpO2/FiO2 or S/F ratio measure of hypoxemia), and Sequential Organ Failure Assessment (SOFA) scores on the day of sampling for flow cytometry analysis (t1-SOFA) and on day before ICU-discharge or ICU-death (t2-SOFA). To assess context in ARDS pathogenesis, we studied biomarkers of pathogenic events in ARDS relevant to neutrophil-mediated secondary tissue injury: interleukin-6 (IL-6 marker of cytokine storms), soluble C5b9 (terminal complex of complement activation), myeloperoxidase or MPO (neutrophil activation), ratio of the number of copies of mitochondrial to nuclear DNA in plasma (mtDNA-NET-formation) 24 , and DEspR+CD11b+ cytoplasts, (anuclear remnants of neutrophils associated with “vital NETosis”) 25 .…”

Factor XIII Measurement and Substitution in Trauma Patients after Admission to an Intensive Care Unit

“…ICU-free days, as a more sensitive primary outcome parameter for clinical trials in critically ill patients, were calculated by subtracting the length of stay for the individual patients in days from 30. The ICU-free day value of 0 (zero) reflected either the death of the patient or a longer than 30-day stay in the ICU [ 10 ].…”

Correlation between Tissue Doppler-derived left ventricular systolic velocity (mitral S’) and left ventricle ejection fraction (LVEF) in sepsis and septic shock: A retrospective cohort study

“…Secondary outcomes were the association between mitral s' and 28-day mortality (28 days counted from ICU admission), hospital-free days, and in-hospital mortality. Hospital-free days were calculated as a composite outcome combining hospital mortality and hospital length of stay, which is calculated as "28 -the length of hospital stay" during the rst 28 days [22].…”