Release of Nociceptin From Granulocytes in Sepsis

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037281
• Other study ID #: 0554
• Status: Completed
• Start date: April 7, 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: April 2019
• Source: University of Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Sepsis Syndrome
• Septic Shock
• Severe Sepsis
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Leicester Royal Infirmary	Leicester	Leicestershire
United Kingdom	University of Leicester	Leicester	Leicestershire

Sponsors (3)

Lead Sponsor	Collaborator
University of Leicester	The Royal College of Anaesthetists, University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Responsive Biosensor Cells Responding to Granulocyte Addition in the Presence and Absence of NOP Antagonist	Measure of N/OFQ presence in granulocytes and associated supernatant	Day 1
Secondary	Granulocyte Count	Count of the number of neutrophils in the original sample	Day 1
Secondary	Mortality In-hospital, at 30 Days	All cause mortality at 30 days	30 days
Secondary	Time to ICU Discharge (or Death if on ICU)		Time to ICU discharge (or death if on ICU)
Secondary	Time to Death or Discharge	Time to death or discharge (days)	Number of days between admission and death or discharge from hospital
Secondary	Acute Physiology and Chronic Health Evaluation (APACHE-2) Score	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	Day 1
Secondary	Sequential Organ Failure Assessment (SOFA) Score	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%)	Day 1