Impact of Albumin on Renal function in critically ill patients with Septic Shock and a high risk of Acute Kidney Injury. A Randomized Controlled Trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Parc Tauli

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23], Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

15 May 2025 → ongoing

Decision date (initial)

2025-02-03

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

Evaluate the efficacy of human albumin infusion in critically ill patients with septic shock and high risk of AKI to avoid severe AKI (defined according to KDIGO consensus stages 2 and 3) during the first 7 days since septic shock onset.

Secondary objectives 4

1. Evaluate the beneficial effects of human albumin infusion in critically ill patients with septic shock and high risk of AKI on 28-day mortality.
2. Evaluate the beneficial effects of human albumin infusion in critically ill patients with septic shock and high risk of AKI on organ support status at 28 day.
3. Evaluate the effect of albumin treatment on endothelial function during the first 7 days of the study.
4. Evaluate the safety of albumin treatment (AEs, SAE, SUSAR).

Conditions and MedDRA coding

Septic shock, acute kidney injury

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Sign of informed consent
2. Male or female ≥18 years and <85 years of age
3. Patients diagnosed with septic shock according to sepsis 3 definition* less than 24 hours before study enrolment. * Presence of sepsis with persistent hypotension despite initial adequate volume resuscitation requiring vasopressors for more than 4 h to maintain MAP>65 mmHg and serum lactate level >2 mmol/L (18 mg/L)
4. Patients with high risk of AKI. A high risk of AKI is defined by values of urinary [TIMP-2] x [IGFBP 7] above 0.3 (ng/ml)2/1,000 (nephrocheck)
5. Fluid responsiveness as determined by clinical judgment or by any invasive or non-invasive measure
6. Treatment with antibiotics, i.e., at least one course in the first 3 hours of suspected infection
7. SOFA score ≥4
8. Women of child-bearing potential must have a negative pregnancy test in urine or serum before inclusion in the study and agree to use highly effective contraceptive methods or have practiced sexual abstinence during the study. Highly effective contraceptive methods will include combined (estrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence

Exclusion criteria 14

1. Patients diagnosed with septic shock more than 24 hours prior to study enrolment
2. Contraindications to receive albumin
3. Acute kidney failure (KDIGO stage 2-3)
4. Chronic Renal Failure (KDIGO stage 3-5) or dialysis
5. A known malignancy that is progressing or has required active treatment within the past 3 months
6. Patients with end-stage disease (unrelated to sepsis), defined as patients who before the current hospitalization are expected to live <6 months (as assessed by the study physician)
7. Known New York Heart Association (NYHA) class II to IV heart failure or unstable angina, acute coronary disease, or myocardial infarction within 6 months before diagnosis of sepsis
8. Known severe immunocompromised state (AIDS, neutropenia, primary immunodeficiencies), or medication known to be immunosuppressive (immunosuppressive, cytotoxic or corticosteroids drugs) for example, malignant diseases, transplant or autoimmune disease. If systemic corticosteroids were administered for short-term (14 days) patients can be included
9. Participation in an interventional investigational study within 30 days before diagnosis of sepsis
10. 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)
11. Albumin administration within the last 21 days
12. Subjects with severe neurological or severe head trauma disorders
13. Pregnant and/or breastfeeding woman
14. Patients who cannot provide prior informed consent and when there is documented evidence that the patient has no legal surrogate decision maker, and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome will be the incidence of AKI, KDIGO stage 2-3 according to KDIGO guidelines during the first 7 days since septic shock onset

Secondary endpoints 4

1. Incidence of 28-day mortality
2. Organ support status at day 28 measured as: length (hours) of vasopressors use; length (days) of invasive mechanical ventilation use; ventilation free days at 28 days; need of renal replacement therapy; and organ support free days at 28 days
3. Levels of: endothelial biomarkers Angiopoietin 1, Angiopoietin 2, MR-ProADM, Selectin, VCAM-1, ICAM-1, Endothelin-1, Thrombomodulin, Syndecan 1-4, Heparan sulfate, VEGF, S1P, and PAI-1
4. Proportion of participants with any AEs and SAEs related to albumin treatment, and also SUSARs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Parc Tauli

Sponsor organisation

Fundacio Parc Tauli

Address

Santa Fe Building, Parc Del Tauli 1 Parc Del Tauli 1

City

Sabadell

Postcode

08208

Country

Spain

Scientific contact point

Organisation

Fundacio Parc Tauli

Contact name

Adrian Ceccato

Public contact point

Organisation

Fundacio Parc Tauli

Contact name

Adrian Ceccato

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications