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Completed

NCT Number: NCT03037281

Release of Nociceptin From Granulocytes in Sepsis

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

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Syndrome Septic Shock Severe Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leicester Royal Infirmary, Leicester, Leicestershire, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Septic

Diagnostic Test

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 names: Healthy volunteers

Primary outcomes

  1. Proportion of Responsive Biosensor Cells Responding to Granulocyte Addition in the Presence and Absence of NOP Antagonist

    Time frame: Day 1

    Measure of N/OFQ presence in granulocytes and associated supernatant

Secondary outcomes

  1. Granulocyte Count

    Time frame: Day 1

    Count of the number of neutrophils in the original sample

  2. Mortality In-hospital, at 30 Days

    Time frame: 30 days

    All cause mortality at 30 days

  3. Time to ICU Discharge (or Death if on ICU)

    Time frame: Time to ICU discharge (or death if on ICU)

  4. Time to Death or Discharge

    Time frame: Number of days between admission and death or discharge from hospital

    Time to death or discharge (days)

  5. Acute Physiology and Chronic Health Evaluation (APACHE-2) Score

    Time frame: Day 1

    The Acute Physiology and Chronic Health Evaluation (APACHE-2) score for the patient.

    APACHE 2 is an international standard,12 variable score from 0-71 reflecting disease severity in the critically unwell during the first 24 hours of illness. The score is a combined measure of illness severity (acute physiology), and background chronic health factors. Increased score represents increased predicted mortality.

    Variables recorded include AaDO2 or PaO2 (depending on FiO2), temperature, mean arterial pressure, blood pH, heart rate, respiratory rate, serum sodium, serum potassium, creatinine, hematocrit, white blood cell count, Glasgow Coma Scale

    Knaus WA, Draper EA, Wagner DP, Zimmerman JE (1985). "APACHE II: a severity of disease classification system". Critical Care Medicine. 13 (10): 818-29

  6. Sequential Organ Failure Assessment (SOFA) Score

    Time frame: Day 1

    The Sequential Organ Failure Assessment (SOFA) score for the patient, a score predictive of mortality in sepsis for intensive care patients based on respiratory, cardiovascular, hepatic, coagulation, renal and neurological function (each scored 0-4, with a maximum overall score of 24). The worst (most deranged) physiological values for the first 24 hours are used. A higher score predicts increased mortality. The mortality breakdown for each sofa score range is - SOFA 0-6 (<10% mortality), 7-9 (15-20%), 10-12 (40-50%), 13-14 (50 - 60%), 15 (> 80%), 16 to 24 (> 90%)

Sponsors and collaborators

Lead sponsor

University of Leicester

Other

Collaborators

  • The Royal College of Anaesthetists
  • University Hospitals, Leicester

Registry information

Official study title

Does the Release Profile of Nociceptin From Immunocytes Differ in Healthy Volunteers and Critically Ill Patients With Sepsis?

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2017
Registry last updated
Jan 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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