Regulation of Endocrine, Metabolic, Immune and Bioenergetic Responses in Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2004 by University College London Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University College London Hospitals
ClinicalTrials.gov Identifier:
NCT00187824
First received: September 11, 2005
Last updated: NA
Last verified: March 2004
History: No changes posted
  Purpose

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, increasing disease severity and risk of death. 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 immune dysfunction in critically ill patients with sepsis and multiple organ failure in the Intensive Care Unit.


Condition
Sepsis
Critical Illness

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Cross-Sectional
Official Title: Regulation of Endocrine, Metabolic, Immune and Bioenergetic Responses in Sepsis

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Estimated Enrollment: 30
Study Start Date: July 2004
Estimated Study Completion Date: August 2007
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 immune dysfunction in critically ill patients with sepsis and multiple organ failure in the Intensive Care Unit.

This study will be undertaken using sequential blood sampling (until ICU discharge) and muscle biopsies (to a maximum of 5) in critically ill patients (a) with or (b) without sepsis plus a comparator group undergoing elective orthopaedic surgery. A variety of hormonal, cytokine, immune and mitochondrial measures wil lbe then made to assess whether any relationship exists between alterations in these different pathways, and whether eventual survivors and non-survivors can be distinguished.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

- 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187824

Contacts
Contact: Mervyn Singer, MBBS MD FRCP +44 207 679 9666 m.singer@ucl.ac.uk

Locations
United Kingdom
UCL Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1
Contact: Mervyn Singer, MD FRCP    +44 207 679 9666    m.singer@ucl.ac.uk   
Sub-Investigator: Martin Stotz, MD         
Sub-Investigator: Lucinda Barrett, MB MRCP         
Sub-Investigator: Patrick Breen, MD         
Sponsors and Collaborators
University College London Hospitals
Investigators
Study Director: Mervyn Singer, MBBS MD FRCP UCL/UCLH
Principal Investigator: Geoff Bellingan, PhD FRCP UCL/UCLH
Principal Investigator: Paul Glynne, PhD FRCP UCL/UCLH
  More Information

No publications provided by University College London Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00187824     History of Changes
Other Study ID Numbers: 04/Q0505/2
Study First Received: September 11, 2005
Last Updated: September 11, 2005
Health Authority: United Kingdom: COREC

Keywords provided by University College London Hospitals:
prospective
observational
hormonal
inflammatory
vioenergetic
immune
sepsis

Additional relevant MeSH terms:
Sepsis
Toxemia
Critical Illness
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on September 30, 2014