Trial DesignProphylactic intravenous use of milrinone after cardiac operation in pediatrics (PRIMACORP) study☆
Section snippets
Study organization
The study design and supervision of the PRIMACORP trial is the responsibility of the Steering Committee, Clinical Endpoint Committee, and Data Safety Monitoring Board (DSMB). In addition to the protocol development, the role of the Steering Committee is to provide academic leadership for the overall conduct of the trial, which includes interpreting and disseminating the results. The DSMB is responsible for overseeing the safety of PRIMACORP participants. The Clinical Endpoint Committee, a
Discussion
Because of the strong relationship between a drop in cardiac index and the possibility of cardiac death, it is imperative that LCOS be identified and treated.3 Parr et al4 evaluated 139 infants and small children ≤48 months old for 72 hours after intracardiac surgery. The mortality rate was 19.4% (n = 27), and more than half the deaths were caused by acute cardiac failure and were associated with a low cardiac index (<2.0 L/min/m2). Wernovsky et al7 evaluated 171 pediatric patients <3 months
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Reprint requests: Gil Wernovsky, MD, Children's Hospital of Philadelphia, Division of Cardiology, 34th and Civic Center Boulevard, Philadelphia, PA 19104. E-mail: [email protected]