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.

Phase 4

Not yet recruiting

Conditions: Septic shock, acute kidney injury

Registration Number: 2024-518475-58-00

Lead Sponsor: Fundacio Parc Tauli

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Sign of informed consent

Male or female ≥18 years and <85 years of age

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)

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)

Fluid responsiveness as determined by clinical judgment or by any invasive or non-invasive measure

Treatment with antibiotics, i.e., at least one course in the first 3 hours of suspected infection

SOFA score ≥4

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

Patients diagnosed with septic shock more than 24 hours prior to study enrolment

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 21 days

Subjects with severe neurological or severe head trauma disorders

Pregnant and/or breastfeeding woman

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

Contraindications to receive albumin

Acute kidney failure (KDIGO stage 2-3)

Chronic Renal Failure (KDIGO stage 3-5) or dialysis

A known malignancy that is progressing or has required active treatment within the past 3 months

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)

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

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

Participation in an interventional investigational study within 30 days before diagnosis of sepsis

Study & Design

Study Type: Not specified

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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		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 Outcome Measures

Name	Time	Method
Proportion of participants with any AEs and SAEs related to albumin treatment, and also SUSARs		Proportion of participants with any AEs and SAEs related to albumin treatment, and also SUSARs
Incidence of 28-day mortality		Incidence of 28-day mortality
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		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
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		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

Trial Locations

Locations (3): Hospital Germans Trias I Pujol
🇪🇸
Badalona, Spain
Hospital Universitari Vall D Hebron
🇪🇸
Barcelona, Spain
Parc Tauli Hospital Universitari
🇪🇸
Sabadell, Spain
Hospital Germans Trias I Pujol
🇪🇸Badalona, Spain
Teresa Maria Tomasa Irriguible
Site contact
+34934978901
ttomasa.germanstrias@gencat.cat