Although all progress notes, ICU flow sheets and medication administration records were reviewed, use of additional laboratory testing and/or diagnostic assessment outside of that which occurred as a part of routine clinical practice was not mandated as part of the study. The pharmacists who collected www.selleckchem.com/products/brefeldin-a.html data were instructed not to share any information related to the data they collected with the clinical team nor make interventions pertaining to propofol therapy. All data were recorded on a study case report form and then entered into a secure web-based database.For the purposes of this study, PRIS was defined as the development of metabolic acidosis and cardiac dysfunction along with at least one of rhabdomyolysis, hypertriglyceridemia or renal failure after the initiation of propofol therapy.

This definition was based on a review of 83 published reports of PRIS, incorporated each pertinent PRIS-associated clinical manifestation listed above and was finalized through investigator consensus. The presence of hypotension, hepatic transaminitis, hypoxia and hyperthermia were not included in the PRIS definition given the low incidence by which they are reported in published case series and the fact that they are commonly observed in the critically ill. Other analyses compared demographic factors, the duration of both propofol use and ICU stay, and patient outcome between PRIS and non-PRIS patients. Additionally, the number of new-onset PRIS-related clinical manifestations experienced per patient, the manner and timing by which the PRIS definition was met, the frequency of each PRIS-related clinical manifestation and the number of PRIS-related clinical manifestations for each day of therapy was determined.

Patient characteristics and outcomes were expressed as mean �� standard deviation, median and interquartile range (IQR) or percent where appropriate. Comparisons between groups were performed using the Student’s t-test, Mann-Whitney U test or the chi-squared test with the Yates correction where appropriate. A P value of less than 0.05 was considered significant for all analyses. All statistical analyses were performed using SPSS 16.0 (SPSS, Chicago, IL, USA).ResultsAmong the 1017 patients followed, 1.1% (11/1017) developed PRIS as it was defined for the purposes of the study (i.e.

, development of metabolic acidosis and cardiac dysfunction along with at least one of: rhabdomyolysis, hypertriglyceridemia or renal failure after the initiation of propofol therapy). The development of metabolic acidosis, cardiac dysfunction and renal failure after the start of propofol therapy accounted for the definition of PRIS being met in all patients where PRIS was identified. GSK-3 One of the PRIS patients also developed hypertriglyceridemia. None of the patients who met our definition for PRIS had rhabdomyolysis nor did their cardiac dysfunction consist of a Brugada-like ECG pattern.