1.1 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.2 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.3 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.4 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.5 Evaluate B cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.6 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.7 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.8 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.9 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.10 Evaluate other immune cell response to albumin treatment
Measured by the Immunology Complex (Discovery Study).
1.1. Identify additional biomarkers of the immune response to albumin treatment.
Measured by the IGCGS score.
1.2.1 Evaluate the functionality of antibody-secreting B cells.
Measurated by B cell function.
1.2.2 Evaluate the functionality of antibody-secreting B cells.
Measurated by serum immunoglobilin levels (g/L).
1.2.3 Evaluate the functionality of antibody-secreting B cells.
Measurated by glycosylation.
1.2.4 Evaluate the functionality of antibody-secreting B cells.
Measurated by blood immunophenotyping.
2.1To further investigate the mechanisms of albumin treatment on the immune system.
Measurated by assessment of whole blood RNA sequencing.
2.2 To further investigate the mechanisms of albumin treatment on the immune system.
Measurated by assessment of single-cell RNA sequencing.
2.3 To further investigate the mechanisms of albumin treatment on the immune system.
Measurated by assessment of CITE-seq.
2.4 To further investigate the mechanisms of albumin treatment on the immune system.
Measurated by assessment of immunophenotyping of B cells by high-dimensional spectral flow cytometry.
3. Evaluate whether albumin activates B cells at the mucosal interface.
Measurated by assessment of circulating levels of immunoglobulins and glycosylated immunoglobulins.
4.1. Evaluate the effect of albumin treatment on systemic inflammation.
Measurated by plasma cytokines: IL-1β, IL-1ra, IL-6, IL-7, IL-8, IL-10, IL-17, TNF-α, TNFr1, IFN-γ, MCP-1, MCP-3, RAGE.
4.2.1 Evaluate kidney.
Measurated by sCr (mg/dL).
4.2.2 Evaluate kidney.
Measurated by urine output.
4.2.3 Evaluate kidney.
Measurated by balance fluid.
4.2.4 Evaluate kidney.
Measurated by KDIGO stage 2-3.
4.2.5 Evaluate kidney.
Measurated by TIMP-2.
4.2.6 Evaluate kidney.
Measurated by IGFBP 7.
4.3.1 To explore the effect of albumin on gut mucosa immunoglobulins.
Measurated by composition of bacterial communities bound to IgA.
4.3.2 To explore the effect of albumin on gut mucosa immunoglobulins.
Measurated by composition of whole fecal bacteria.
4.3.3 To explore the effect of albumin on gut mucosa immunoglobulins.
Measurated by antibody-binding profile of microbes.
4.3.4 To explore the effect of albumin on gut mucosa immunoglobulins.
Measurated by bacterial reactivity of peripheral blood antibodies.
5.1 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by angiopoeitin 1.
5.2 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by angiopoeitin 2.
5.3 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by MR-proADM.
5.4 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by Selectin.
5.5 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by VCAM-1.
5.6 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by ICAM-1.
5.7 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by endothelin-1.
5.8 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by thrombomodulin.
5.9 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by syndecan 1-4.
5.10 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by prot C (mg/L).
5.11 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by heparan sulfate.
5.12 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by VEGF.
5.13 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by sphingosine-1-phosphate (S1P).
5.14 Evaluate the effect of albumin on endothelial and glycocalix function.
Measurated by PAI-1.
6.1 Time on vasopressors.
Measurated by time on vasopressors.
6.2 Time on mechanical ventilation.
Measurated by time on mechanical ventilation.
6.3 Time on renal replacement.
Measurated by time on renal replacement.
7. Proportion of patients with secondary infections.
Measurated by the number of patients with secondary infections.
8.1. Proportion of patients dead at 28 and 90 days.
Measurated by the number of patients dead at 28 and 90 days.
8.2. Proportion of patients re-admitted to ICU at 28 days.
Measurated by the number of re-admitted to UCI at 28 days.
8.3. Proportion of re-hospitalized patients at 28 days.
Measurated by the number of re-hospitalized patients at 28 days.
8.4.1 Evaluate the sequential SOFA score.
Measurated by SOFA score.
8.4.2 Evaluate the sequential APACHE II score.
Measurated by APACHE II score.
8.4.3 Evaluate the sequential TISS-28 score.
Measurated by TISS-28 score.
9. Evaluate quality of life (QoL) at day 90.
Measurated by the EQ-5D-5L questionnaire.
10. Proportion of participants with any AEs related to albumin treatment, SAEs and SUSARs.
Measured by the number of AE, SAEs and SUSARS presented by the participants.