Phase
Condition
Sepsis And Septicemia
Low Blood Pressure (Hypotension)
Soft Tissue Infections
Treatment
Placebo
Sargramostim: Leukine (Genzyme USA)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
ICU patients presenting a severe sepsis or a septic shock associated with a sepsis-induced immunosuppression.
- Severe sepsis OR septic shock defined by the association of: at least 2 criteriaof Systemic Inflammation Response Syndrome (SIRS) a clinically or microbiologicallydefined infection and respectively at least one organ failure (level ≥ 2 in oneorgan failure of the SOFA score) OR the need of a vasopressor treatment (epinephrineor norepinephrine ≥ 0,25mg/kg/min for at least 6 hrs to maintain a systolic pressure ≥ 90 mmHg or a mean arterial pressure ≥ 65 mmHg).
- AND Sepsis-induced immunosuppression: reduced mHLA-DR levels (< 8,000 monoclonalantibodies (mAb) per cell at D3).
Exclusion
Exclusion Criteria:
- Therapeutic limitation
Evolutive hemopathy, neutropenia < 500/mm3, stemcell transplant
Solid tumor with on-going chemotherapy or radiotherapy
Human immunodeficiency virus (HIV) infection with CD 4 count < 200 cell/mm3
Immunosuppressive treatment (including corticosteroid at immunosuppressive dose : > 10 mg equivalent prednisolone and cumulative dose > 700 mg)
Primary immunodeficiency .
Extra corporeal circulation within one month
Recent cardio-pulmonary resuscitation (within the current clinical episode)
Patients admitted in ICU for extensive burns
Contraindications to sargramostim
Pregnant or lactating women
Participation to another interventional study.
Study Design
Connect with a study center
CHU Amiens Hopital SUD
Amiens, 80054
FranceSite Not Available
CHU Amiens Hopital SUD
Amiens 3037854, 80054
FranceSite Not Available
CHU Gabriel MONTPIED
Clermont-Ferrand, 63003
FranceSite Not Available
CHU Estaing 1 place Lucie et Raymond Aubrac
Clermont-Ferrand 3024635, 63003
FranceSite Not Available
CHU Gabriel MONTPIED
Clermont-Ferrand 3024635, 63003
FranceSite Not Available
CHU Estaing 1 place Lucie et Raymond Aubrac
Clermont-ferrand, 63003
FranceSite Not Available
CHU Gabriel MONTPIED
Clermont-ferrond, 63003
FranceSite Not Available
CHU de Grenoble- Hopital Michallon
Grenoble, 38043
FranceSite Not Available
CHU de Grenoble-Hopital Michallon
Grenoble, 38043
FranceSite Not Available
CHU de Grenoble- Hopital Michallon
Grenoble 3014728, 38043
FranceSite Not Available
CHU de Grenoble-Hopital Michallon
Grenoble 3014728, 38043
FranceSite Not Available
Hopital Edouard Herriot
Lyon, 69003
FranceSite Not Available
Hopital de la Croix Rousse
Lyon, 69317
FranceSite Not Available
Hopital Edouard Herriot
Lyon 2996944, 69003
FranceSite Not Available
Hopital de la Croix Rousse
Lyon 2996944, 69317
FranceSite Not Available
APHM Hopital Nord
Marseille, 13915
FranceSite Not Available
APHM Hopital de la Timone
Marseille, 13005
FranceSite Not Available
CHU la Conception
Marseille, 13005
FranceSite Not Available
APHM Hopital Nord
Marseille 2995469, 13915
FranceSite Not Available
APHM Hopital de la Timone
Marseille 2995469, 13005
FranceSite Not Available
CHU la Conception
Marseille 2995469, 13005
FranceSite Not Available
CHU Montpellier
Montpellier, 34295
FranceSite Not Available
Hopital Saint Eloi
Montpellier, 34295
FranceSite Not Available
CHU Montpellier
Montpellier 2992166, 34295
FranceSite Not Available
Hopital Saint Eloi
Montpellier 2992166, 34295
FranceSite Not Available
CHU de Nantes
Nantes, 44093
FranceSite Not Available
PTMC CHU de Nantes
Nantes, 44093
FranceSite Not Available
CHU de Nantes
Nantes 2990969, 44093
FranceSite Not Available
PTMC CHU de Nantes
Nantes 2990969, 44093
FranceSite Not Available
CHU de Nîmes
Nîmes, 30029
FranceSite Not Available
CHU de Nîmes
Nîmes 2990363, 30029
FranceSite Not Available
Centre hospitalier Lyon Sud
Pierre Benite, 69495
FranceSite Not Available
Centre hospitalier Lyon Sud
Pierre-Bénite 2987314, 69495
FranceSite Not Available
CHU Hopital Nord
Saint-Etienne, 42055
FranceSite Not Available
CHU de Saint-Etienne
Saint-Etienne, 42055
FranceSite Not Available
CHU Hopital Nord
Saint-Etienne 2980291, 42055
FranceSite Not Available
CHU de Saint-Etienne
Saint-Etienne 2980291, 42055
FranceSite Not Available

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