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

Albimmune

Status and phase: Withdrawn; Phase 2

Conditions: Septic Shock

Treatments: Drug: Human albumin; Other: Saline solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05645887

2022-001949-20

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 84 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Drug: Human albumin

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

Placebo Comparator group

Description:

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

Treatment:

Other: Saline solution