Clinical trial NCT03037281: Release of Nociceptin From Granulocytes in Sepsis
Official title: Does the Release Profile of Nociceptin From Immunocytes Differ in Healthy Volunteers and Critically Ill Patients With Sepsis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Sepsis Syndrome
Severe Sepsis
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: The Royal College of Anaesthetists
name: University Hospitals, Leicester
First posted: 2017-01-31
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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


Eligibility 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.

Primary outcomes:
measure: Proportion of Responsive Biosensor Cells Responding to Granulocyte Addition in the Presence and Absence of NOP Antagonist
timeFrame: Day 1
Secondary outcomes:
measure: Granulocyte Count
timeFrame: Day 1
measure: Mortality In-hospital, at 30 Days
timeFrame: 30 days
measure: Time to ICU Discharge (or Death if on ICU)
timeFrame: Time to ICU discharge (or death if on ICU)
measure: Time to Death or Discharge
timeFrame: Number of days between admission and death or discharge from hospital
measure: Acute Physiology and Chronic Health Evaluation (APACHE-2) Score
timeFrame: Day 1
measure: Sequential Organ Failure Assessment (SOFA) Score
timeFrame: Day 1
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
state: Leicestershire
city: Leicester
country: United Kingdom
facility: University of Leicester
state: Leicestershire
Study officials:
affiliation: University of Leicester
name: Christopher P Hebbes, BSc
role: PRINCIPAL_INVESTIGATOR
References: