Developmental Clinical Sciences: Does GM-CSF restore effective neutrophil function in critically ill patients?
- Conditions
- Topic: Generic Health Relevance and Cross Cutting ThemesSubtopic: Generic Health Relevance (all Subtopics)Disease: Critical CareNot Applicable
- Registration Number
- ISRCTN95325384
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 70
Current inclusion criteria as of 20/05/2014:
1. Male and female, aged >= 18 years
2. Patients admitted to intensive care unit within the last 72 hours
3. Fulfill criteria for systemic inflammatory response syndrome (SIRS)
4. Has required support of one or more organ systems (invasive ventilation, inotropes or haemofiltration) during current ICU stay
5. Survival over next 48 hours deemed most likely outcome by responsible ICU clinician
6. Neutrophil phagocytic capacity <50%
Previous inclusion criteria:
1. Male and female, aged >= 18 years
2. Patients admitted to intensive care unit within the last 48 hours
3. Fulfill criteria for systemic inflammatory response syndrome (SIRS)
4. Require exogenous support of one or more organ systems (invasive ventilation, inotropes or haemofiltration)
5. Predicted to require organ support for further 48 hours or more
6. Survival is considered to be the most likely outcome by the attending clinician at the time of enrolment
7. Neutrophil CD88 expression is low (i.e. corresponding to < 50% neutrophil phagocytic capacity)
Current exclusion criteria as of 20/05/2014:
1. Absence/refusal of informed consent
2. Current prescription of a colony stimulating factor
3. Any history of adverse reaction/allergy to GMCSF
4. Total white cell count >30x109/litre at the time of screening
5. Haemoglobin < 7.5g/dl at the time of screening
6. Age < 18 years
7. Pregnancy or lactation
8. Known in-born errors of neutrophil metabolism
9. Known haematological malignancy and/or known to have > 10% peripheral blood blast cells
10. Known aplastic anaemia or pancytopaenia
11. Platelet count <50x10^9/litre
12. Chemotherapy or radiotherapy within the last 24 hours
13. Solid organ or bone marrow transplantation
14. Use of maintenance immunosuppressive drugs other than maintenance corticosteroids (allowed up to prednisolone 10mg/day or equivalent)
15. Known human immunodeficiency virus (HIV) infection
16. Active connective tissue disease (eg rheumatoid disease, systemic lupus erythematosus) requiring active pharmacological treatment
17. ST segment elevation myocardial infarction, acute pericarditis (by ECG criteria) or pulmonary embolism (radiologically confirmed) in the previous week
18. Involvement in any study involving an investigational medicinal product in the previous 30 days
Previous exclusion criteria:
1. Absence/refusal of informed consent
2. Current prescription of a colony stimulating factor
3. Any history of adverse reaction/allergy to GMCSF
4. Total white cell count > 20x10^9/litre at the time of screening
5. Haemoglobin <8.5g/dl at the time of screening
6. Age < 18 years
7. Pregnancy or lactation
8. Known in-born errors of neutrophil metabolism
9. Known haematological malignancy and/or known to have > 10% peripheral blood blast cells
10. Known aplastic anaemia or pancytopaenia
11. Platelet count <50x10^9/litre
12. Known history of cancer (unless undergone curative resection or treatment)
13. Solid organ or bone marrow transplantation
14. Use of maintenance immunosuppressive drugs other than maintenance corticosteroids (allowed up to prednisolone 10mg/day or equivalent)
15. Known human immunodeficiency virus (HIV) infection
16. Active connective tissue disease (eg rheumatoid disease, systemic lupus erythematosus) requiring active pharmacological treatment
17. ST segment elevation myocardial infarction, acute pericarditis (by ECG criteria) or pulmonary embolism (radiologically confirmed) in the previous week
18. Involvement in any study involving an investigational medicinal product in the previous 30 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Current primary outcome measures as of 20/05/2014:<br>Neutrophil phagocytic capacity 2 days after administration of GM-CSF/placebo (as measured by the percentage of neutrophils ingesting = 2 zymosan particles ex vivo).<br><br>Previous primary outcome measures:<br>Neutrophil phagocytic capacity 2 days after GM-CSF injection
- Secondary Outcome Measures
Name Time Method