Status:
UNKNOWN
Regulation of Endocrine, Metabolic, Immune and Bioenergetic Responses in Sepsis
Lead Sponsor:
University College London Hospitals
Conditions:
Sepsis
Critical Illness
Eligibility:
All Genders
16+ years
Brief Summary
The hypothesis of this study is that bioenergetic failure in human sepsis, related to endocrine, metabolic and mitochondrial dysfunction, is a major determinant of defective host immune responses, inc...
Detailed Description
The objectives of this study are to examine the relationship between the severity of illness, and temporal changes in the activity of endocrine, metabolic and bioenergetic pathways, and consequent imm...
Eligibility Criteria
Inclusion
- Group 1: healthy control patients Patients undergoing elective total hip replacement will be eligible for enrollment in Group 1 after written informed consent has been obtained. Only 1 blood sample and 1 fat and muscle biopsy will be taken intra-operatively
- Group 2: non-septic, critically ill patients Patients requiring intensive care within 48 hours of admission to hospital from home, for a non-septic/non-inflammatory pathology will be eligible for enrollment in the study after informed agreement has been obtained from the closest family member (see Consent below). At enrolment, Group 2 patients must have received mechanical ventilation commencing within 48 hours of admission to intensive care, should be likely to require mechanical ventilation for at least 48 hours, and must not fulfil the 2001 International Sepsis Definition Conference criteria for severe sepsis or septic shock
- Group 3: patients with severe sepsis or septic shock Patients requiring intensive care within 48 hours of admission to hospital from home, and evidence of severe sepsis (organ dysfunction due to infection) or septic shock as defined by the 2001 International Sepsis Definition Conference criteria, will be eligible for enrollment in the study after informed agreement has been obtained from their next-of-kin. Patients with underlying chronic liver disease are excluded from this group, and will be enrolled separately into Group 4.
- Group 4: patients with severe sepsis and underlying chronic liver disease Patients requiring intensive care admission, with underlying Child-Pugh Class A or B, biopsy-proven liver cirrhosis, within 24 h of the onset of severe sepsis (organ dysfunction due to infection) or septic shock as defined by the 2001 International Sepsis Definition Conference criteria), will be eligible for enrollment in the study after informed agreement has been obtained from their next-of-kin
Exclusion
- \- Age \<18 years
- Child-Pugh Class C liver disease
- Chronic dialysis-dependent renal failure
- Hepatitis B or C infection
- Immunosuppression (e.g. haematological malignancy, neutropenia, HIV infection)
- Immunosuppressive drug therapy within past 6 months
- Patient receiving oral or IV steroid therapy for greater than 1 week, within 6 months prior to ICU admission
- Muscle biopsy contraindicated in presence of coagulopathy (INR \>2, platelet count \< 30,000)\*
- Next-of-kin declines agreement / patient declines consent
- Patient receiving thyroid hormone therapy prior to ICU admission
- \*This does not exclude enrolment into the study, particularly in the case of Group 4 patients who frequently develop a coagulopathy as part of their underlying liver dysfunction
Key Trial Info
Start Date :
July 1 2004
Trial Type :
OBSERVATIONAL
End Date :
August 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00187824
Start Date
July 1 2004
End Date
August 1 2007
Last Update
September 16 2005
Active Locations (1)
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1
UCL Hospitals NHS Foundation Trust
London, London, United Kingdom, NW1