N/A
N=14
Release of Nociceptin From Granulocytes in Sepsis
Sepsis · Septic Shock · Sepsis Syndrome · Severe Sepsis
Bottom Line
View on ClinicalTrials.gov: NCT03037281 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Proportion of Responsive Biosensor Cells Responding to Granulocyte Addition in the Presence and Absence of NOP Antagonist — 34.25907426; 5.882352941; 44.17193917; 25.13095238 mean % responsive biosensor cells
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Septic (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Leicester
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Responsive Biosensor Cells Responding to Granulocyte Addition in the Presence and Absence of NOP Antagonist |
34.25907426; 5.882352941; 44.17193917; 25.13095238; 17.86976912; 39.97303622 | — |
| SECONDARY Granulocyte Count |
5.07; 2.05; 0.98; 1.61 | — |
| SECONDARY Mortality In-hospital, at 30 Days |
3; 0 | — |
| SECONDARY Time to ICU Discharge (or Death if on ICU) |
7.5 | — |
| SECONDARY Time to Death or Discharge |
17.5 | — |
| SECONDARY Acute Physiology and Chronic Health Evaluation (APACHE-2) Score |
19.8 | — |
| SECONDARY Sequential Organ Failure Assessment (SOFA) Score |
9.33 | — |
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;
- 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.
- Male or Female, aged 18 years or above.
- Diagnosed with sepsis and admitted to the intensive care unit.
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Healthy Volunteers;
- Participant is willing and able to give informed consent for participation in the study. Must be able to read and understand English.
- Male or Female, aged 18 years or above and be
- In good health.
- 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
- Able (in the Investigators opinion) and willing to comply with all study requirements.
- 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).
- 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.
- Participants who have participated in another research study involving an investigational product in the past 12 weeks.
Data sourced from ClinicalTrials.gov (NCT03037281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.