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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.
EU CTIS ID: 2024-518475-58-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
Who can join
- 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
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.