Implementation of a norepinephrine-based protocol for management of septic shock: a pilot feasibility study.

Background: The subject of the best vasopressor for hemodynamic management of septic shock (SS) is controversial. One of the difficulties in planning such studies is that physicians are reluctant to use one vasopressor exclusively, and there is considerable variation in practice. The aim of this study was to test the feasibility of implementing a single pressor-based algorithm (in this case, norepinephrine [NE]).

Methods: A NE-based algorithm was applied prospectively to 100 consecutive SS patients. A formal training program was implemented before starting the protocol and applied to 72 physicians and nurses involved in intensive care unit (ICU) patient care. Compliance, protocol violations, probable adverse effects, and outcome were evaluated on a daily basis by an independent group of fellows and a research nurse.

Results: In 100 patients, there were 7,139 hours of algorithm use. Only 13 protocol violations were observed, mostly in the timing of inotropic drugs. Senior staff physicians or busy night shifts accounted for most of these violations. ICU mortality was 33%, which is comparable to that predicted by Acute Physiology and Chronic Health Evaluation II and Sequential Organ Failure Assessment scores. Adverse events probably related to NE were not observed.

Conclusions: The present algorithm, applied after a strict training program, obtained an overall good acceptance and compliance with very few protocol violations in more than 7,000 hours of use. Safety was demonstrated by a global mortality comparable to that predicted by severity scores and absence of specific drug-related morbidity. The implementation of a single pressor-based algorithm for SS is feasible and safe.