Release of Nociceptin From Granulocytes in Sepsis

NCT ID: NCT03037281

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-07
• Study Completion Date: 2019-06-30

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

Conditions

Sepsis; Septic Shock; Sepsis Syndrome; Severe Sepsis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

Septic

Intervention Type: 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.

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.

Septic

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Healthy volunteers

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Royal College of Anaesthetists

OTHER

Sponsor Role: collaborator

University Hospitals, Leicester

OTHER

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher P Hebbes, BSc

Role: PRINCIPAL_INVESTIGATOR

University of Leicester

Locations

Leicester Royal Infirmary

Leicester, Leicestershire, United Kingdom

University of Leicester

Leicester, Leicestershire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

0554

Identifier Type: -

Identifier Source: org_study_id