SepsisNCT00187824
Regulation of Endocrine, Metabolic, Immune and Bioenergetic Responses in Sepsis
An observational study of Sepsis and Critical Illness, run by University College London Hospitals at 1 site in United Kingdom.
Trial 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, increasing disease severity and risk of death. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis, Critical Illness
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2004to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
UCL Hospitals NHS Foundation Trust
London, London, NW1
Mervyn Singer, MD FRCP, +44 207 679 9666, m.singer@ucl.ac.uk
Martin Stotz, MD
About this study
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.
Read the 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.
- Conditions
- Sepsis, Critical Illness
- Keywords
- prospective, observational, hormonal, inflammatory, vioenergetic, immune, sepsis
- Medical subject headings
- Sepsis, Critical Illness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJul 2004
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Mervyn Singer, MBBS MD FRCP, Study director, UCL/UCLHGeoff Bellingan, PhD FRCP, Principal investigator, UCL/UCLHPaul Glynne, PhD FRCP, Principal investigator, UCL/UCLH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187824
- Sponsor's protocol ID
- 04/Q0505/2
- Status last verified
- Mar 2004
- First submitted
- 11 Sep 2005
- Last updated
- 16 Sep 2005
- Results posted
- No
Publications
Carre JE, Orban JC, Re L, Felsmann K, Iffert W, Bauer M, Suliman HB, Piantadosi CA, Mayhew TM, Breen P, Stotz M, Singer M. Survival in critical illness is associated with early activation of mitochondrial biogenesis. Am J Respir Crit Care Med. 2010 Sep 15;182(6):745-51. doi: 10.1164/rccm.201003-0326OC. Epub 2010 Jun 10.
PubMed 20538956
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Endocrine, Metabolic, Immune and Bioenergetic Responses in Sepsis
- ClinicalTrials.gov ID
- NCT00187824
- Acronym / sponsor ID
- 04/Q0505/2
- Conditions
- Sepsis, Critical Illness
- Keywords
- prospective, observational, hormonal, inflammatory, vioenergetic, immune, sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Jul 2004
- Study completion
- Aug 2007
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2005.
- Derived from this study: PubMed 20538956Carre JE, Orban JC, Re L, Felsmann K, Iffert W, Bauer M, Suliman HB, Piantadosi CA, Mayhew TM, Breen P, Stotz M, Singer M. Survival in critical illness is associated with early activation of mitochondrial biogenesis. Am J Respir Crit Care Med. 2010 Sep 15;182(6):745-51. doi: 10.1164/rccm.201003-0326OC. Epub 2010 Jun 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mervyn Singer, MBBS MD FRCP study director
UCL/UCLH
Geoff Bellingan, PhD FRCP principal investigator
UCL/UCLH
Paul Glynne, PhD FRCP principal investigator
UCL/UCLH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Critical Illness, run by University College London Hospitals at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mervyn Singer, MBBS MD FRCP (+44 207 679 9666, m.singer@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2005.