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| Name | Class |
|---|---|
| The Royal College of Anaesthetists | OTHER |
| University Hospitals, Leicester | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Granulocyte Count | Count of the number of neutrophils in the original sample | Day 1 |
| Mortality In-hospital, at 30 Days | All cause mortality at 30 days |
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Inclusion Criteria:
For septic patients;
Healthy Volunteers;
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.
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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
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| Name | Affiliation | Role |
|---|---|---|
| Christopher P Hebbes, BSc | University of Leicester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leicester Royal Infirmary | Leicester | Leicestershire | LE1 5WW | United Kingdom | ||
| University of Leicester |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: 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. |
| FG001 | 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: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Biosensor cells | Posted | Mean | Standard Deviation | mean % responsive biosensor cells | Day 1 | Biosensor cells | Biosensor cells |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: 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. |
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Technical problems with both measurement and immunocyte extraction contributed to high variability with the assay and inconsistencies.Small numbers of subjects recruited precluded robust statistical analysis.Basophil extraction very low - not viable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Christopher Hebbes | University of Leicester | 0116 252 2522 | christopher.hebbes@le.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2018 | Aug 24, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D018746 | Systemic Inflammatory Response Syndrome |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
|
| 30 days |
| Time to ICU Discharge (or Death if on ICU) | Time to ICU discharge (or death if on ICU) |
| Time to Death or Discharge | Time to death or discharge (days) | 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 | 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%) | Day 1 |
| Leicester |
| Leicestershire |
| LE2 7LX |
| United Kingdom |
| BG001 | 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: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Septic (+NOP Antagonist SB612111) | Cells harvested from patients with sepsis, treated in an environment containing the NOP antagonist SB612111 |
| OG002 | Septic (N/OFQ Control) | Control treatment of biosensor cells with N/OFQ as a control |
| OG003 | 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: 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. |
| OG004 | Healthy Volunteers (+NOP Antagonist SB612111) | Cells harvested from healthy volunteers in an environment containing the NOP antagonist SB612111 |
| OG005 | Healthy Volunteers (N/OFQ Control) | Cells taken from healthy volunteers treated with N/OFQ as a control |
|
|
| Secondary | Granulocyte Count | Count of the number of neutrophils in the original sample | Posted | Mean | Full Range | x10^7 cells ml-1 | Day 1 |
|
|
|
| Secondary | Mortality In-hospital, at 30 Days | All cause mortality at 30 days | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Time to ICU Discharge (or Death if on ICU) | Posted | Median | Full Range | days | Time to ICU discharge (or death if on ICU) |
|
|
|
| Secondary | Time to Death or Discharge | Time to death or discharge (days) | Posted | Median | Full Range | 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 | Posted | Mean | Full Range | score on a scale | 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%) | Posted | Mean | Full Range | score on a scale | Day 1 |
|
|
|
| 3 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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: 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. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D012769 | Shock |