Human serum albumin for Septic shock|Acute kidney injury

Inclusion criteria

• {"criterion_text":"- Sign of informed consent"}
• {"criterion_text":"- Male or female ≥18 years and <85 years of age"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Fluid responsiveness as determined by clinical judgment or by any invasive or non-invasive measure"}
• {"criterion_text":"- Treatment with antibiotics, i.e., at least one course in the first 3 hours of suspected infection"}
• {"criterion_text":"- SOFA score ≥4"}
• {"criterion_text":"- 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

• {"criterion_text":"- Patients diagnosed with septic shock more than 24 hours prior to study enrolment"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Albumin administration within the last 21 days"}
• {"criterion_text":"- Subjects with severe neurological or severe head trauma disorders"}
• {"criterion_text":"- Pregnant and/or breastfeeding woman"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Contraindications to receive albumin"}
• {"criterion_text":"- Acute kidney failure (KDIGO stage 2-3)"}
• {"criterion_text":"- Chronic Renal Failure (KDIGO stage 3-5) or dialysis"}
• {"criterion_text":"- A known malignancy that is progressing or has required active treatment within the past 3 months"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Participation in an interventional investigational study within 30 days before diagnosis of sepsis"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Incidence of Acute Kidney Injury defined as KDIGO stage 2-3 according to KDIGO guidelines during the first 7 days since septic shock onset"}

Secondary endpoints

• {"endpoint_text":"- Incidence of 28-day mortality","definition_or_measurement_approach":"All-cause mortality at 28 days"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured parameters at day 28: hours of vasopressor use, days of invasive mechanical ventilation, ventilation-free days at 28 days, requirement for renal replacement therapy, and organ support-free days at 28 days"}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measurement of specified endothelial biomarker plasma/serum levels (listed biomarkers) as defined in protocol"}
• {"endpoint_text":"- Proportion of participants with any AEs and SAEs related to albumin treatment, and also SUSARs","definition_or_measurement_approach":"Proportion of participants experiencing adverse events (AEs), serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) related to albumin treatment"}

Spain

Earliest CTIS Part Ii Submission Date

17-12-2024

Latest Decision Or Authorization Date

03-02-2025

Processing Time Days

48

Number Of Sites

3

Number Of Participants

100

Primary sponsor

Full Name

Fundacio Parc Tauli

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain