Post-operative immunological stimulation in severe immune suppression. The study population is made up of adult, which are able to give their inform consent by their own. The patients are undergoing elective esophageal resection or pancreas resection. Both men and women should enrolled in the clinical trial. The participants included in the clinical trial will not be selected with regard to their sex. The clinical trial is a pilot study.
Conditions
Interventions
Trade Name: Mutagrip
Product Name: Mutagrip
Pharmaceutical Form: Solution for injection
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: AgU antigen unit(s)
Sponsors
Charité - Universitaetsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - HLA-DR expression on monozytes = 10.000 antigens/monocyte on the first postoperative day - elective pancreas resection or esophagus resection, - male or female subjects, aged =18, - Written informed consent, - negative pregnancy test (ßHCG in urine), - women of childbearing age with highly effective contraception (PEARL-Index 2 years postmenopausal, - no participation in another investigational drug trial during the present clinical trial; Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - HLA-DR expression on monocytes > 10.000 antigens/monocyte on the first postoperative day - missing informed consent, - aged 2g/dl - creatinin > 1,5g/dl - AST/ALT > 90U/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A postoperative vaccination with influenza-vaccine or postoperative treatment with sargramostim within the phase of severe immunsuppression, leads to (compared to placebo) an improvement of immunoreactivity by absence of an immuno paralysis (measured by the normalisation of the HLA-DR expression of monocytes, > 10.000 antigens/monocyte).;Secondary Objective: - postoperative infection rate - incidence of postoperative delirium (CAM-ICU, NuDESC, DDS) - postoperative ventilation time (hours), ICU length of stay, Charité length of stay, APACHE-II-Score, SAPS-II-Score, SOFA-Score, TISS-28-Score - The first 33 included patients will be analysed in regard to the following parameters: 1. Parameters of immune system function - levels of different cytokines - Th1/Th2 ratio, - Th17/Treg ratio, 2. quantitative expression of transcription factors (T-bet, Eomesodermin, GATA-3, Foxp3, ROR?t, PU.1) and proteins (SOCS-3, SOCS-1, TGF-ß, IL-17) as well as the synthesis of associated effector proteins ;Primary end point(s): HLA-DR expression of monocytes A postoperative vaccination with influenza-vaccine or postoperative treatment with sargramostim within the phase of severe immunsuppression, leads to (compared to placebo) an improvement of immunoreactivity by absence of an immuno paralysis (measured by the normalisation of the HLA-DR expression of monocytes, > 10.000 antigens/monocyte). ;Timepoint(s) of evaluation of this end point: HLA-DR expression of monocytes on the first 5 post-operative days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For all 60 study patients: 1.1. Post-operative infection rate 1.2. Post-operative incidence of delir (CAM-ICU, NuDesc, DDS) 1.3. Ventilation time, intensive care unit (ICU) stay, length of stay, APACHE II score, SAPS II score, SOFA score, TISS-28 score For the first 33 study patients: 2.1. Cytokines in serum, Th1/ Th2-ratio, Th17/ Treg-ratio, further parameters of immune function 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-y, TNF-a, IL-23, IL-10) as well as the synthesis of the corresponding effector proteins ;Timepoint(s) of evaluation of this end point: For all 60 study patients on the first 9 post-operative days: 1.1. Post-operative infection rate 1.2. Post-operative incidence of delir (CAM-ICU, NuDesc, DDS) 1.3. Ventilation time, intensive care unit (ICU) stay, length of stay, APACHE II score, SAPS II score, SOFA score, TISS-28 score For the first 33 study patients on the first 5 post-operative days: 2.1. Cytokines in serum, Th1/ Th2-ratio, Th17/ Treg-ratio, further parameters of immune function 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-y, TNF-a, IL-23, IL-10) as well as the synthesis of the corresponding effector proteins | — |
Countries
Germany
Contacts
Public ContactUniv. - Prof. Dr. Claudia Spies
Charité - Universitaetsmedizin Berlin, Department of Anaesthesiology and Intensive Care Medicine, CVK, CCM
Outcome results
None listed