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Release of Nociceptin From Granulocytes in Sepsis

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ClinicalTrials.gov Identifier: NCT03037281
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
The Royal College of Anaesthetists
University Hospitals, Leicester
Information provided by (Responsible Party):
University of Leicester

Brief Summary:

Nociceptin is a protein found in the body, with a number of functions in the central nervous system, blood vessels and the gut. There is evidence that it may have a role in controlling the immune response to infection, and may act as a link between the brain and immune system.

In infection, or after surgery, there is an increase in nociceptin, and subjects greater elevations of nociceptin have a poorer outcome. There is evidence that cells of the immune system may produce nociceptin, although it is not yet known which cells are capable of producing it, and what "switches on" production.

This study aims to determine

  1. Which cells of the immune system can produce nociceptin
  2. If there is a difference in the ability to produce nociceptin between healthy volunteers and patients with severe infections

Condition or disease Intervention/treatment
Sepsis Septic Shock Sepsis Syndrome Severe Sepsis Diagnostic Test: Septic

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Does the Release Profile of Nociceptin From Immunocytes Differ in Healthy Volunteers and Critically Ill Patients With Sepsis?
Actual Study Start Date : April 7, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort Intervention/treatment
Septic
Patients admitted to the intensive care unit with a diagnosis of sepsis. For the purposes of this study, patients must have a diagnosis of sepsis; SIRS (2 of pulse >90, WCC, BP, Oxygen(Dellinger et al., 2013)) with microbiological evidence of infection (positive blood culture, urine dipstick, compatible history or examination, radiographic evidence)
Diagnostic Test: Septic
30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately.
Other Name: Healthy volunteers

Healthy volunteers
Healthy volunteers will be approached within the Department of Cardiovascular Sciences, and provided with the PIS, with consent taken by one of the investigating team.
Diagnostic Test: Septic
30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately.
Other Name: Healthy volunteers




Primary Outcome Measures :
  1. Detection of Nociceptin release from subpopulations of granulocytes [ Time Frame: Day 1 ]
    The detection of nociceptin release in a fluorescence based microscopy assay when granulocytes harvested from septic patients and healthy volunteers degranulate. (Binary - present or not present)


Secondary Outcome Measures :
  1. Overall Granulocyte count [ Time Frame: Day 1 ]
    Count of the number of granulocytes in the original sample

  2. Absolute neutrophil count [ Time Frame: Day 1 ]
    Count of the number of neutrophils in the original sample

  3. Absolute eosinophil count [ Time Frame: Day 1 ]
    Count of the number of eosinophils in the original sample

  4. Absolute basophil count [ Time Frame: Day 1 ]
    Count of the number of basophils in the original sample

  5. Mortality in-hospital, at 30 days and 1 year [ Time Frame: 30 days and 1 year ]
  6. Length of ITU stay, and hospital stay [ Time Frame: 30 days and 1 year ]
  7. Length of hospital stay [ Time Frame: 30 days and 1 year ]
  8. Acute Physiology and Chronic Health Evaluation (APACHE-2) score [ Time Frame: Day 1 ]
    The APACHE-2 score for the patient

  9. Sequential Organ Failure Assessment (SOFA) score [ Time Frame: Day 1 ]
    The SOFA score for the patient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers - Adults, staff or students at the Univesity of Leicester, with no significant comorbidity Septic patients - Adult patients admitted to the adult intensive care unit, Leicester Royal Infirmary, with a diagnosis of sepsis
Criteria

Inclusion Criteria:

  • For septic patients;

    1. Participant is willing and able to give informed consent for participation in the study, or if lacking capacity, a next of kin or advocate is willing and able to give assent for participation in the study. Must be able to read and understand English.
    2. Male or Female, aged 18 years or above.
    3. Diagnosed with sepsis and admitted to the intensive care unit.
    4. Able (in the Investigators opinion) and willing to comply with all study requirements.
    5. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Healthy Volunteers;

  1. Participant is willing and able to give informed consent for participation in the study. Must be able to read and understand English.
  2. Male or Female, aged 18 years or above and be
  3. In good health.
  4. Have had no course of medication, whether prescribed or over-the-counter, in the four weeks before first study dose and no individual doses in the final two weeks other than mild analgesia, vitamins and mineral supplements or, for females, oral contraceptives
  5. Able (in the Investigators opinion) and willing to comply with all study requirements.
  6. Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria:

  • 1. Conditions which may make phlebotomy hazardous to the participant (such as significant bleeding disorders or anaemia, or allergy), or to the investigator (blood viral infection).

    2. Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

    3. Participants who have participated in another research study involving an investigational product in the past 12 weeks.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037281


Contacts
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Contact: Christopher P Hebbes, BSc cph16@leicester.ac.uk
Contact: David G Lambert, PhD dgl3@leicester.ac.uk

Locations
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United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, Leicestershire, United Kingdom, LE1 5WW
Contact: Christopher P Hebbes, BSc       cph16@leicester.ac.uk   
University of Leicester Recruiting
Leicester, Leicestershire, United Kingdom, LE2 7LX
Contact: Christopher P Hebbes, BSc       cph16@leicester.ac.uk   
Sponsors and Collaborators
University of Leicester
The Royal College of Anaesthetists
University Hospitals, Leicester
Investigators
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Principal Investigator: Christopher P Hebbes, BSc University of Leicester

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Responsible Party: University of Leicester
ClinicalTrials.gov Identifier: NCT03037281     History of Changes
Other Study ID Numbers: UNOLE 0554
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock, Septic
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Shock
Nociceptin
Nocistatin
Vasodilator Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents