Human Albumin Treatment in Adult Septic Shock. A Study Evaluating Immune Response and Organ Failure.

NCT05645887 | Withdrawn Phase 2 DMC

• 1 other identifier: 2022-001949-20
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (10)

• 1.1 Evaluate B cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 0

• 1.2 Evaluate B cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 1

• 1.3 Evaluate B cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 3

• 1.4 Evaluate B cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 7

• 1.5 Evaluate B cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 14

• 1.6 Evaluate other immune cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 0

• 1.7 Evaluate other immune cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 1

• 1.8 Evaluate other immune cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 3

• 1.9 Evaluate other immune cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 7

• 1.10 Evaluate other immune cell response to albumin treatment

  Measured by the Immunology Complex (Discovery Study).

  at day 14

Secondary Outcomes (47)

• 1.1. Identify additional biomarkers of the immune response to albumin treatment.

  at day 0, 1, 3, 7 and 14.

• 1.2.1 Evaluate the functionality of antibody-secreting B cells.

  at day 0, 1, 3, 7 and 14.

• 1.2.2 Evaluate the functionality of antibody-secreting B cells.

  at day 0, 1, 3, 7 and 14.

• 1.2.3 Evaluate the functionality of antibody-secreting B cells.

  at day 0, 1, 3, 7 and 14.

• 1.2.4 Evaluate the functionality of antibody-secreting B cells.

  at day 0, 1, 3, 7 and 14.

Study Arms (2)

Human Albumim (20%, 300mL, 60gr) in 180 min IV

EXPERIMENTAL

Further doses of albumin (60g/l) will be administered daily from day 0 to day 7 in patients with serum albumin concentrations \<35 g/L.

Drug: Human albumin

Saline solution 0,9% (500mL) in 180 min IV

PLACEBO COMPARATOR

Saline solution will be given from day 0 to day 7.

Other: Saline solution

Interventions

Human albumin DRUG

Human albumin from day 0 to 7 if serum albumin concentrations \<35g/l.

Human Albumim (20%, 300mL, 60gr) in 180 min IV

Saline solution OTHER

Saline solution from day 0 to day 7.

Saline solution 0,9% (500mL) in 180 min IV

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years and \<85 years of age.
• Community-acquired pneumonia, urinary, skin or biliary infection.
• Treatment with antibiotics at least one course in the first 6 hours of suspected infection.
• 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).
• SOFA score ≥ 5 points.
• Albumin plasma level \<35g/L.
• Lymphocytes count \< 1,100 cel/mL.
• Admitted to ICU or IMU

You may not qualify if:

• Septic shock lasting for more than 24h.
• ECMO or hemoadsortion therapy.
• Contraindications to receive albumin.
• Nosocomial or healthcare-associated infections (surgical intervention or hospitalization within 30 days prior to diagnosis of sepsis).
• Chronic Renal Failure (KIDGO stage 3-5) or dialysis.
• Liver cirrhosis.
• A known malignancy that is progressing or has required active treatment within the past 3 months.
• 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).
• 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.
• Known immunocompromised state, including human immunodeficiency virus infection, or medication known to be immunosuppressive.
• Participation in an interventional investigational study within 30 days prior to diagnosis of sepsis.
• 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).
• Albumin administration within the last 14 days.
• Subjects with severe neurological or severe head trauma disorders.
• Pregnant and/or breast-feeding woman.

Sponsors & Collaborators

• Albimmune SL: lead

MeSH Terms

Conditions

Shock, Septic

Interventions

Serum Albumin, Human; Saline Solution

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 12, 2022
• Study Start: February 1, 2024
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: July 31, 2024

Record last verified: 2023-07