A study comparing granulocyte macrophage-colony stimulating factor (GM-CSF), vaccination and placebo in patients who suffer from immune depression after resection of either pancreas or oesophagus
| ISRCTN | ISRCTN27114642 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27114642 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/12/2008
- Registration date
- 27/02/2009
- Last edited
- 08/12/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Claudia Spies
Scientific
Scientific
Augustenburger Platz 1
Berlin
13353
Germany
| Phone | +49 (0)30 450 551001 |
|---|---|
| claudia.spies@charite.de |
Study information
| Study design | Prospective randomised double-blinded double-dummy placebo-controlled monocentre pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Influence of post-operative influenza vaccination versus granulocyte macrophage-colony stimulating factor (GM-CSF) in immune-compromised patients undergoing pancreatic or oesophageal resection on the course of immunosuppression and the post-operative infection rate: a prospective, randomised, double-blinded, double-dummy, placebo-controlled, monocentre pilot study |
| Study acronym | ART VI |
| Study hypothesis | The post-operative vaccination or the post-operative treatment with granulocyte macrophage-colony stimulating factor (GM-CSF) produces a higher sufficiency of immune reactivity shown through a normalisation of monocyte human leukocyte antigen-DR (HLA-DR) expression while avoiding immune paralysis in patients suffering from severe immune suppression. On 22/10/10 this record was updated to include an extended overall trial end date, from 31/3/2010 to 31/03/2011, due to the yearly unavailability of study vaccine for several months. The secondary outcomes have also been updated and more details may be found in the relevant field with the above update date. On 09/06/2015 the following changes were made to the trial record: 1. The overall trial start date was changed from 26/10/2008 to 13/05/2008. 2. The overall trial end date was changed from 31/03/2011 to 16/04/2011. 3. The target number of participants was changed from 60 to 63. |
| Ethics approval(s) | The local ethics committee (Ethics board committee Berlin, Landesamt fur Gesundheit und Soziales [LaGeSo], Berlin) was informed throughout and gave permission for the performance of this clinical trial on the 01/09/2008 (ref : ZS EK 15 287/08) |
| Condition | Post-operative immunological stimulation in severe immune suppression |
| Intervention | In this study the potential of post-operative immunological stimulation in patients with immune suppression is compared to placebo: 1. 0.5 ml Mutagrip® 2008/2009 2. 250 µg/m^2 body surface Sargramostim 3. Physiological saline Duration of the treatment: minimal 24 hours, maximum 72 hours Frequency: daily subcutaneous injection and daily 24 hour perfusion for a maximum of 3 days Follow up: 9 post-operative days as well as safety |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | HLA-DR expression of monocytes on the first 5 post-operative days |
| Secondary outcome measures | Current information as of 22/10/10: 1. For all 60 study patients: 1.1. Post-operative infection rate and infection days on the first 9 post-operative days 1.2. Post-operative incidence of delirium and delirium days (CAM-ICU, NuDesc, DDS) on the first 9 post-operative days 1.3. Ventilation time, intensive care unit (ICU) stay, length of stay, APACHE II score, SAPS II score, SOFA score, TISS-28 score (ventilation time and scores on the first 9 post-operative days) 2. For the first 33 study patients: 2.1. Cytokines in serum, Th1/ Th2-ratio, Th17/ Treg-ratio, further parameters of immune function on the first 5 post-operative days 2.2. Quantitative expression of transcription factors (T-bet, Eomesodermin, Gata-3, Foxp3, ROR-gamma t, PU.1, STAT-1, STAT-3, STAT-5, NF kappa B) and proteins (SOCS-3, SOCS-1, SOCS-5, TGF-beta, IL-17, IL-6, IL-10, IFN-?, TNF-a, IL-23, IL-10) as well as the synthesis of the corresponding effector proteins on the first 5 post-operative days Initial information at time of registration: 1. Cytokines in serum, Th1/ Th2-ratio, Th17/ Treg-ratio, further parameters of immune function on the first 5 post-operative days 2. Quantitative expression of transcription factors (T-bet, Eomesodermin, Gata-3, Foxp3, ROR-gamma t, PU.1, STAT-1, STAT-3, STAT-5, NF kappa B) and proteins (SOCS-3, SOCS-1, SOCS-5, TGF-beta, IL-17, IL-6, IL-10, IFN-?, TNF-a, IL-23, IL-10) as well as the synthesis of the corresponding effector proteins on the first 5 post-operative days 3. Post-operative infection rate on the first 9 post-operative days 4. Post-operative incidence of delir (CAM-ICU, NuDesc, DDS) on the first 9 post-operative days 5. Ventilation time, intensive care unit (ICU) stay, length of stay, APACHE II score, SAPS II score, SOFA score, TISS-28 score (ventilation time and scores on the first 9 post-operative days) |
| Overall study start date | 13/05/2008 |
| Overall study end date | 16/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 63 |
| Participant inclusion criteria | 1. Tumour resection of the upper aero-digestive tract 2. Informed consent 3. Adulthood (aged greater than or equal to 18 years, either sex) 4. Negative pregnancy test 5. Highly effective contraception in premenopausal women 6. No participation in any other pharmaceutical study during the course of the study 7. Monocyte HLA-DR expression below 10.000 antigens/surface on the first post-operative day |
| Participant exclusion criteria | 1. Lack of willingness to accept the storage and transfer of pseudonymous data 2. Incapacitation 3. Staff member of the Charité Berlin 4. Pregnancy 5. Lactation 6. Congenital or acquired blood disorder 7. Chemotherapy or radiotherapy within the last 28 days 8. Leukaemia 9. Emergency operation 10. Proven infection within the last 7 days 11. Known infection of hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or positive result during pre-operative screening 12. Allergy against any ingredients of the trial drug 13. Autoimmune diseases 14. Intake of immunosuppressive drugs up to 4 weeks before surgery 15. Cardiac arrhythmia without adequate therapy 16. Unstable angina pectoris 17. Symptomatic congenital heart defect 18. History of thrombosis or thromboembolic incidents 19. Body weight below 50 kg 20. Thrombocytes below or equal to 100,000/µl on the day before surgery 21. Neutrophils below or equal to 1,500/µl on the day before surgery 22. Haemoglobin below or equal to 8 g/dl on the day before surgery 23. Bilirubin above 2 g/dl on the day before surgery 24. Creatinine above 1.5 g/dl on the day before surgery 25. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) above 90 U/l on the day before surgery |
| Recruitment start date | 26/10/2008 |
| Recruitment end date | 16/04/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charité - Universitätsmedizin Berlin
Berlin
13353
Germany
13353
Germany
Sponsor information
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Hospital/treatment centre
Hospital/treatment centre
Universitaetsklinik fur Anasthesiologie mit Schwerpunkt operative Intensivmedizin
Augustenburger Platz 1
Berlin
13353
Germany
| Phone | +49 (0)30 450 551001 |
|---|---|
| claudia.spies@charite.de | |
| Website | http://anaesthesieintensivmedizin.charite.de/ |
"ROR" |
https://ror.org/001w7jn25 |
Funders
Funder type
Hospital/treatment centre
Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Medical School - Charité - University Medicine Berlin
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/12/2015 | Yes | No |
Editorial Notes
08/12/2015: Publication reference added.
