Septic Shock MedDRA version: 23.1 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Albutein
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Albutein
CAS Number: 70024-90-7
Other descriptive name: Human albumin solution
Concentration unit: g/l gram(s)/litr
Sponsors
ALBIMMUNE S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female = 18 years and 65 mmHg and having a serum lactate level > 2mmol/L (18mg/L). 5. SOFA score = 5 points. 6. Albumin plasma level =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Septic shock lasting for more than 24h. 2. ECMO or hemoadsortion therapy. 3. Contraindications to receive albumin. 4. Nosocomial or healthcare-associated infections (surgical intervention or hospitalization within 30 days prior to diagnosis of sepsis). 5. Chronic Renal Failure (KIDGO stage 3-5) or dialysis. 6. Liver cirrhosis. 7. A known malignancy that is progressing or has required active treatment within the past 3 months. 8. Patient with end-stage disease (unrelated to sepsis) defined as patients who prior to the current hospitalization are expected to live < 6 months (as assessed by the study physician). 9. Known New York Heart Association (NYHA) class II to IV heart failure or unstable angina, acute coronary disease or myocardial infarction within 6 months prior to diagnosis of sepsis. 10. Known immunocompromised state, including human immunodeficiency virus infection, or medication known to be immunosuppressive. 11. Participation in an interventional investigational study within 30 days prior to diagnosis of sepsis. 12. Likely to be non-compliant or uncooperative during the study (e.g. substance abuse, uncontrolled psychiatric disorder or any chronic condition that may interfere with the study). 13. Albumin administration within the last 14 days. 14. Subjects with severe neurological or severe head trauma disorders. 15. Pregnant and/or breast-feeding woman. 16. Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision marker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effect of albumin treatment on B-cell gene expression in patients with septic shock.;Secondary Objective: 1. Identify additional biomarkers of B-cell and other immune defense responses, including ex vivo assessment of the functionality of antibody-secreting cells and neutrophils. 2. To further investigate the mechanisms of action of albumin treatment on B-cell function. 3. Investigate whether albumin activates B-cells at the mucosal interface. 4. Evaluate the effect of albumin treatment on systemic inflammation and the incidence of organ dysfunction. 5. Evaluate the effect of albumin on endothelial and glycocalix function. 6. Evaluate time of vasopressors, mechanical ventilation and renal replacement therapy. 7. Evaluate secondary infections at 28 days. 8. Evaluate mortality at 28 and 90 days, hospital and ICU readmission. 9. Evaluate quality of life (QoL) at baseline and 90 days. 10. Evaluate the safety of albumin treatment (SAE, SUSAR, AEs).;Primary end point(s): Evaluate B cell and other immune cell response to albumin treatment through the Immunology Complex and other Gen Set scores. Scores are based on the expression of 5 to 10 genes that estimate the expression of the whole B-cell and other immune cell transcriptome.;Timepoint(s) of evaluation of this end point: Duration of the study participation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Identify additional biomarkers of the immune response to albumin treatment through the scores and evaluate the functionality of antibody-secreting B cells through B cell and neutrophil function, serum immunoglobulin levels, glycosylation and blood immunophenotyping. 2. To further investigate the mechanisms of albumin treatment on the immune system by assessing: - Whole blood RNA sequencing - Single–cell RNA sequencing and CITE-seq - Immunophenotyping of B cells by high-dimensional spectral flow cytometry 3. Evaluate whether albumin activates B cells at the mucosal interface through the assessment of circulating levels of immunoglobulins and glycosylated immunoglobulins. 4.1. Evaluate the effect of albumin treatment on systemic inflammation through the measurement of plasma cytokines: IL-1ß, IL-1ra, IL-6, IL-7, IL-8, IL-10, IL-17, TNF-a, TNFr1, IFN-?, MCP-1, MCP-3, RAGE. 4.2. Evaluate kidney [sCr, urine output, balance fluid, KDIGO stage 2-3, TIMP-2 and IGFBP 7 (nephrocheck) 4.3. To explore the effect of albumin on gut mucosa immunoglobulins: - Composition of bacterial communities bound to IgA. - Composition of whole fecal bacteria. - Antibody-binding profile of microbes. - Bacterial reactivity of peripheral blood antibodies. 5. Evaluate the effect of albumin on endothelial and glycocalix function through the measurement of angiopoeitin 1 and 2, MR-proADM, Selectin, VCAM-1, ICAM-1, endothelin-1, thrombomodulin, syndecan 1-4, prot C, heparan sulfate, VEGF, sphingosine-1-phosphate (S1P) and PAI-1. 6. Time on vasopressors, mechanical ventilation and renal replacement. 7. Proportion of patients with secondary infections. 8. Proportion of patients dead at 28 and 90 days, proportion of patients re-admitted to ICU and hospital at 28 days and evaluate the sequential SOFA and APACHE II scores. 9. Evaluate quality of life (QoL) through the EQ-5D-5L questionnaire at day 90. 10. Proportion of participants with any AEs related to albumin tre | — |
Countries
Spain
Contacts
Public ContactAnna Cruceta
CTU clínic
Outcome results
None listed