Clinical trial NCT05645887: Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.
Official title: Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Septic Shock
Lead sponsor: Albimmune SL
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this phase 2, multicenter, randomized, controlled study is to evaluate the effect of albumin treatment on B cell and other immune cell gene exptression in adults with septic shock.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 18 years and \<85 years of age.
2. Community-acquired pneumonia, urinary, skin or biliary infection.
3. Treatment with antibiotics at least one course in the first 6 hours of suspected infection.
4. Meets Septic Shock criteria defined by the presence of sepsis with persistent hypotension despite initial adequate volume resuscitation requiring vasopressors for more than 4h to maintain MAP\>65 mmHg and having a serum lactate level \> 2mmol/L (18mg/L).
5. SOFA score ≥ 5 points.
6. Albumin plasma level \<35g/L.
7. Lymphocytes count \< 1,100 cel/mL.
8. Admitted to ICU or IMU

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.

Primary outcomes:
measure: 1.1 Evaluate B cell response to albumin treatment
timeFrame: at day 0
measure: 1.2 Evaluate B cell response to albumin treatment
timeFrame: at day 1
measure: 1.3 Evaluate B cell response to albumin treatment
timeFrame: at day 3
measure: 1.4 Evaluate B cell response to albumin treatment
timeFrame: at day 7
measure: 1.5 Evaluate B cell response to albumin treatment
timeFrame: at day 14
measure: 1.6 Evaluate other immune cell response to albumin treatment
timeFrame: at day 0
measure: 1.7 Evaluate other immune cell response to albumin treatment
timeFrame: at day 1
measure: 1.8 Evaluate other immune cell response to albumin treatment
timeFrame: at day 3
measure: 1.9 Evaluate other immune cell response to albumin treatment
timeFrame: at day 7
measure: 1.10 Evaluate other immune cell response to albumin treatment
timeFrame: at day 14
Secondary outcomes:
measure: 1.1. Identify additional biomarkers of the immune response to albumin treatment.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 1.2.1 Evaluate the functionality of antibody-secreting B cells.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 1.2.2 Evaluate the functionality of antibody-secreting B cells.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 1.2.3 Evaluate the functionality of antibody-secreting B cells.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 1.2.4 Evaluate the functionality of antibody-secreting B cells.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 2.1To further investigate the mechanisms of albumin treatment on the immune system.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 2.2 To further investigate the mechanisms of albumin treatment on the immune system.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 2.3 To further investigate the mechanisms of albumin treatment on the immune system.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 2.4 To further investigate the mechanisms of albumin treatment on the immune system.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 3. Evaluate whether albumin activates B cells at the mucosal interface.
timeFrame: at day 0, 3, 7 and 14.
measure: 4.1. Evaluate the effect of albumin treatment on systemic inflammation.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 4.2.1 Evaluate kidney.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 4.2.2 Evaluate kidney.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 4.2.3 Evaluate kidney.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 4.2.4 Evaluate kidney.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 4.2.5 Evaluate kidney.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 4.2.6 Evaluate kidney.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 4.3.1 To explore the effect of albumin on gut mucosa immunoglobulins.
timeFrame: at day 0, 3, 7 and 14.
measure: 4.3.2 To explore the effect of albumin on gut mucosa immunoglobulins.
timeFrame: at day 0, 3, 7 and 14.
measure: 4.3.3 To explore the effect of albumin on gut mucosa immunoglobulins.
timeFrame: at day 0, 3, 7 and 14.
measure: 4.3.4 To explore the effect of albumin on gut mucosa immunoglobulins.
timeFrame: at day 0, 3, 7 and 14.
measure: 5.1 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.2 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.3 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.4 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.5 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.6 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.7 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.8 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.9 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.10 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.11 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.12 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.13 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 5.14 Evaluate the effect of albumin on endothelial and glycocalix function.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 6.1 Time on vasopressors.
timeFrame: 14 days
measure: 6.2 Time on mechanical ventilation.
timeFrame: 14 days
measure: 6.3 Time on renal replacement.
timeFrame: 14 days
measure: 7. Proportion of patients with secondary infections.
timeFrame: 90 days
measure: 8.1. Proportion of patients dead at 28 and 90 days.
timeFrame: 90 days
measure: 8.2. Proportion of patients re-admitted to ICU at 28 days.
timeFrame: 28 days
measure: 8.3. Proportion of re-hospitalized patients at 28 days.
timeFrame: 28 days
measure: 8.4.1 Evaluate the sequential SOFA score.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 8.4.2 Evaluate the sequential APACHE II score.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 8.4.3 Evaluate the sequential TISS-28 score.
timeFrame: at day 0, 1, 3, 7 and 14.
measure: 9. Evaluate quality of life (QoL) at day 90.
timeFrame: At day 0 and 90
measure: 10. Proportion of participants with any AEs related to albumin treatment, SAEs and SUSARs.
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References: