Status:
TERMINATED
Hemodynamic and Inflammatory Effects of Abrupt Versus Tapered Corticosteroid Discontinuation in Septic Shock
Lead Sponsor:
The Cleveland Clinic
Conditions:
Septic Shock
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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 inclu...
Detailed Description
Current therapy for septic shock includes antimicrobials, fluid resuscitation, catecholamines, and measures to improve tissue oxygen delivery. The use of corticosteroids as an adjunctive treatment in ...
Eligibility Criteria
Inclusion
- Patients who meet the following criteria will be enrolled in the study:
- suspected septic shock
- initiation of hydrocortisone 50mg IV Q6H (per MICU protocol)
- written informed consent signed by patient or legal surrogate
- Septic shock is defined by meeting all of the following requirements:
- Clinical evidence of infection. Clinical evidence of infection is defined as the presence of a known or probable source of infection that has necessitated the initiation of systemic antimicrobial therapy. Clinical evidence of infection could include (but is not limited to) one or more of the following:
- presence of increased number of PMNs (neutrophils) in normally sterile body fluid
- positive culture or gram stain of blood, sputum, urine, or normally sterile body for a pathogenic microorganism
- chest radiograph consistent with a diagnosis of pneumonia with a positive culture, gram stain, diagnostic bronchoalveolar lavage, or protected specimen brush for a respiratory tract pathogen
- focus of infection identified by visual inspection (e.g., ruptured bowel found at surgery, wound with purulent drainage, radiographic or Computed tomographic evidence of an abscess or osteomyelitis, etc.) and
- patient has an underlying disease or condition that is highly likely to be associated with infection (e.g., ascending cholangitis, ischemic bowel, etc.)
- Two of the following:
- Core temperature either \> 38°C (\> 100.4°F) or \< 36°C (\< 96.8°F)
- Tachycardia. Heart rate greater \> 90 beats/minute
- Respiratory rate \> 20 b/min or PaCO2 \< 32 torr, or need for mechanical ventilation due to sepsis
- WBC \> 12 or \< 4 K/mm3
- End-organ cardiovascular dysfunction defined as hypotension unresponsive to fluid replacement necessitating vasopressor therapy, or lactate ≥4 mmol/L
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01150409
Start Date
May 1 2008
End Date
August 1 2010
Last Update
April 2 2018
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195