SepsisNCT03037281
Release of Nociceptin From Granulocytes in Sepsis
An observational study of Sepsis and Septic Shock, run by University of Leicester at 2 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Septic Shock, Sepsis Syndrome
- What is being tested?
- Septic
- How many people
- 14 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 7 Apr 2016to 30 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Leicester Royal Infirmary
Leicester, Leicestershire, LE1 5WW
University of Leicester
Leicester, Leicestershire, LE2 7LX
About this study
Official title: Does the Release Profile of Nociceptin From Immunocytes Differ in Healthy Volunteers and Critically Ill Patients With 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.
Read more
This study aims to determine
- Which cells of the immune system can produce nociceptin
- 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
- Being tested
- Septic
- Medical subject headings
- Sepsis, Shock, Septic, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SepticDiagnostic test
Also called Healthy volunteers
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Septic | |
| 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. Receives: Diagnostic Test: Septic |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (6)
Granulocyte Count
Count of the number of neutrophils in the original sample
Measured: Day 1
Mortality In-hospital, at 30 Days
All cause mortality at 30 days
Measured: 30 days
Time to ICU Discharge (or Death if on ICU)
Measured: Time to ICU discharge (or death if on ICU)
Time to Death or Discharge
Time to death or discharge (days)
Measured: Number of days between admission and death or discharge from hospital
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
Measured: Day 1
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%)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start7 Apr 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- The Royal College of Anaesthetists, University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Christopher P Hebbes, BSc, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037281
- Sponsor's protocol ID
- 0554
- Status last verified
- Apr 2019
- First submitted
- 25 Jan 2017
- Last updated
- 6 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Release Profile of Nociceptin From Immunocytes Differ in Healthy Volunteers and Critically Ill Patients With Sepsis?
- ClinicalTrials.gov ID
- NCT03037281
- Acronym / sponsor ID
- 0554
- Conditions
- Sepsis, Septic Shock, Sepsis Syndrome, Severe Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- The Royal College of Anaesthetists, University Hospitals, Leicester
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 6 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Which cells of the immune system can produce nociceptin
- If there is a difference in the ability to produce nociceptin between healthy volunteers and patients with severe infections
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Septic | – | Diagnostic Test: SepticPatients 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) |
| Healthy volunteers | – | Diagnostic Test: SepticHealthy volunteers will be approached within the Department of Cardiovascular Sciences, and provided with the PIS, with consent taken by one of the investigating team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (13 listed)
- For septic patients;
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SepticAlso: Healthy volunteers30mls 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. | Diagnostic test | Healthy volunteers, Septic |
Primary outcome
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
6 secondary outcomes
Granulocyte Count
Time frame: Day 1
Mortality In-hospital, at 30 Days
Time frame: 30 days
Time to ICU Discharge (or Death if on ICU)
Time frame: Time to ICU discharge (or death if on ICU)
Time to Death or Discharge
Time frame: Number of days between admission and death or discharge from hospital
Acute Physiology and Chronic Health Evaluation (APACHE-2) Score
Time frame: Day 1
Sequential Organ Failure Assessment (SOFA) Score
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher P Hebbes, BSc principal investigator
University of Leicester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic Shock, run by University of Leicester at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Responsive Biosensor Cells Responding to Granulocyte Addition in the Presence and Absence of NOP Antagonist (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.