Spanish project on benchmarks related to recombinant human activated protein C use: best clinical practices identification

Background

Recombinant human activated protein C (rhAPC) has been shown to significantly reduce mortality in severe sepsis (SS) patients.

Purpose

To identify best clinical practices (BCPs) using several benchmarks (BMs) related to rhAPC administration as the starting point.

Methods

Five Spanish experts on SS and main investigators involved in the PROWESS trial were interviewed in order to identify BCPs for rhAPC administration with regard to the following BMs also obtained from the same experts: BM1) SS identification; BM2) clinical or microbiologically documented infection; BM3) standardized criteria for infection focus identification; BM4) SS considered as the main diagnosis; BM5) length of SS induced organ dysfunctions (OD) < 48 hours; BM6) no limitation of life support measures; BM7) adequate standard therapy; BM8) rhAPC administration. Interviews were oriented to identify BCPs to succeed in reaching the BMs when considering rhAPC administration in clinical practice. Each BCP implied key factors and an objective.

Results

The following BCPs were identified for each BM: BM1) SS patient considered a critically ill patient, consensus criteria for SS definition, early identification of SS. BM2-BM3) Complete medical history; radiological and macroscopic examinations, basic microbiological study, other medical specialties' involvement. BM4) SS documented as main reason for patient admission. BM5) Use of validated score systems, unified required OD degree (SOFA score > 2), undocumented OD does not imply normality; no consideration of chronic ODs. BM6) Evaluation of previous health status and concomitant medical history, involvement of patient's family and other health professionals, no scale score considered as criterion for rhAPC indication. BM7) Protocol-driven antibiotic therapy, antibiogram, control of infection focus, sequential order in shock therapy, early mechanical ventilation. BM8) Lack of rhAPC contraindications, drug prescribed by a critical care physician.

Conclusions

The use of BMs related to the clinical use of rhAPC allows the identification of BCPs for BMs compliance, which may lead to an optimization of the drug cost-effectiveness