Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Septic Shock
In brief
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.
Key facts
- Study ID
- NCT01150409
- Run by
- The Cleveland Clinic
- People needed
- 11
- Starts
- 2008-05-01
- Expected to finish
- 2010-08-01
- Last updated by the study team
- 2018-04-02
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- age less than 18
- previous systemic corticosteroid therapy in the past 90 days (prednisone >5 mg/d or equivalent)
- pregnancy
- Acquired Immune Deficiency Syndrome (AIDS)
- hematological malignancies
- advanced form of cancer with less than 30-day life expectancy
- patients who receive fludrocortisone
- evidence of prior acute myocardial infarction
Where it is running
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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