Objective To determine whether an 18-month vanguard phase, in the Therapeutic Hypothermia after Pediatric Cardiac Arrest (THAPCA) trials, confirmed study feasibility and patient safety, a prerequisite to continued funding by the sponsor. Design Randomized controlled trial Setting Pediatric intensive care and pediatric cardiac care units in 15 clinical sites in the United States and Canada Patients Children, aged 48 hours to 18 years of age, with return of circulation after cardiac arrest Interventions Therapeutic hypothermia versus therapeutic normothermia Measurements and Main Results The first 15 of 20 potential sites to obtain IRB and subcontract approvals were selected as vanguard sites. IRB approvals were obtained 92 days (median, interquartile range [IQR] 65–114) and subcontracts signed 34 days (IQR 20–48) after distribution. Sites screened subjects 13 days (IQR 9–21) and enrolled the first subjects 64 days (IQR 13–154) after study launch. The recruitment milestone was reached four months ahead of schedule with no safety concerns identified. Overall recruitment in this ongoing trial remains on target. Conclusions The THAPCA vanguard phase proved beneficial for the investigators and funding agency. Since complex multicenter trials are rarely ready to launch when grant funds are received, the vanguard allowed time to refine the protocol and recruitment approaches. Competition for vanguard positions led to expedient IRB and subcontract completion. Early success and sustained momentum contributed to recruitment at or above goals. Financial risks to the sponsor were minimized by tying funding for the full trial to achieving pre-specified milestones. A vanguard phase may be a desirable strategy for the successful conduct of other complex clinical trials. Clinical Trial Registration NCT00880087 and NCT00878644 http://clinicaltrials.gov/ct2/show/NCT00880087?term=pediatric+hypothermia&rank=4 http://clinicaltrials.gov/ct2/show/NCT00878644?term=pediatric+hypothermia&rank=5
Background Nosocomial infection remains an important health problem in long stay (> 3 days) pediatric intensive care unit (PICU) patients. Admission risk factors related to the development of nosocomial infection in long stay immune competent patients in particular are not known. Methods Post-hoc analysis of the previously published Critical Illness Stress induced Immune Suppression (CRISIS) prevention trial database, to identify baseline risk factors for nosocomial infection. Because there was no difference between treatment arms of that study in nosocomial infection in the population without known baseline immunocompromise, both arms were combined and the cohort that developed nosocomial infection was compared with the cohort that did not. Results There were 254 long stay PICU patients without known baseline immunocompromise. Ninety (35%) developed nosocomial infection, and 164 (65%) did not. Admission characteristics associated with increased nosocomial infection risk were increased age, higher PRISM III score, the diagnoses of trauma or cardiac arrest, and lymphopenia (p < 0.05). The presence of sepsis or infection at admission was associated with reduced risk of developing nosocomial infection (p < 0.05). In multivariable analysis, only increasing age, cardiac arrest, and existing lymphopenia remained significant admission risk factors (p < 0.05); whereas trauma tended to be related to nosocomial infection development (p = 0.07). Conclusions These data suggest that increasing age, cardiac arrest, and lymphopenia predispose long stay PICU patients without known baseline immunocompromise to nosocomial infection. These findings may inform pre-hoc stratification randomization strategies for prospective studies designed to prevent nosocomial infection in this population.
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