Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock
Status:
Terminated
Trial end date:
2010-08-01
Target enrollment:
Participant gender:
Summary
The proposed study will evaluate the potential benefit of a tapered course of hydrocortisone
compared to abrupt cessation in patients initiated on hydrocortisone for septic shock. The
study will include adult patients in the medical intensive care unit (MICU) who meet criteria
for corticosteroid therapy for septic shock according to the current MICU protocol.All
patients will receive 7 days of hydrocortisone (50mg/Q6hrs) as part of the routine management
of septic shock, before being randomly assigned to receive hydrocortisone taper versus no
taper. The primary study endpoint is the incidence of hypotension within 7 days after
randomization. Secondary endpoints will include incidence of adrenal insufficiency, and
changes in the inflammatory status (assessed by cytokine measurements) before, during, and
after corticosteroid discontinuation. The cytokines to be measured include IL-1, IL-6, IL-9,
IL-10, and TNF. Since there has not been a randomized clinical trial to investigate the
potential benefit of weaning septic patients off low-dose hydrocortisone as opposed to
stopping abruptly, this study has potential to change clinical practice by leading to a
consistent approach of corticosteroid discontinuation and to a better understanding of their
impact on the inflammatory modulation in septic shock.