Study on the Effect of Human Serum Albumin in Critically Ill Patients with Septic Shock at High Risk of Acute Kidney Injury

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What is this study about?

This clinical trial is focused on studying the effects of a treatment for patients who are critically ill with septic shock and have a high risk of developing acute kidney injury (AKI). Septic shock is a severe infection that causes dangerously low blood pressure, and AKI is a sudden decrease in kidney function. The treatment being tested is an infusion of human serum albumin, a protein derived from human blood, which is given through a solution for infusion.

The purpose of the study is to evaluate whether the infusion of human serum albumin can help prevent severe AKI in these patients during the first week after the onset of septic shock. Participants in the study will receive either the human serum albumin treatment or a placebo. The study will monitor the participants’ kidney function and overall health for several weeks to assess the treatment’s effectiveness and safety.

Throughout the study, researchers will also track other health outcomes, such as the need for additional organ support, the length of time patients require treatments like mechanical ventilation, and overall survival rates over a 28-day period. The study aims to provide valuable insights into whether human serum albumin can improve outcomes for patients with septic shock and a high risk of AKI.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of septic shock, and risk of acute kidney injury (AKI).

Informed consent is required, and a negative pregnancy test is necessary for women of child-bearing potential.

2 initial assessment

An initial assessment is conducted to evaluate the patient’s condition, including the measurement of urinary biomarkers to determine the risk of AKI.

The SOFA score is calculated to assess the severity of organ dysfunction.

3 treatment administration

The treatment involves the administration of Albutein 200 g/l solution for infusion, which contains human serum albumin.

The solution is given through an intravenous infusion, with the dosage and frequency determined by the medical team based on the patient’s condition.

4 monitoring period

The primary focus during the first 7 days is to monitor the incidence of AKI according to the KDIGO guidelines.

Regular assessments are conducted to track the patient’s response to treatment and any changes in their condition.

5 follow-up assessments

Secondary outcomes are evaluated, including 28-day mortality rates and the status of organ support.

Additional measurements include levels of specific biomarkers and the occurrence of any adverse events related to the treatment.

6 completion

The study concludes with a final assessment to determine the overall impact of the treatment on renal function and patient outcomes.

Data collected throughout the trial is analyzed to evaluate the efficacy and safety of the treatment.

Who Can Join the Study?

Sign an informed consent form, which means you agree to participate in the study after understanding what it involves.
Be a male or female aged 18 years or older, but younger than 85 years.
Have been diagnosed with septic shock according to the sepsis 3 definition within the last 24 hours. Septic shock is a severe infection causing dangerously low blood pressure that doesn’t improve with fluids and requires medication to maintain blood pressure. It also involves a high level of a substance called lactate in the blood.
Be at high risk of acute kidney injury (AKI). This risk is determined by a specific test measuring certain proteins in the urine.
Show fluid responsiveness, meaning your body responds to fluid treatment, as judged by a doctor or through tests.
Have started treatment with antibiotics within the first 3 hours of suspected infection.
Have a SOFA score of 4 or higher. The SOFA score is a way to assess the severity of organ dysfunction in the body.
If you are a woman who can become pregnant, you must have a negative pregnancy test before joining the study and agree to use effective birth control methods or abstain from sexual activity during the study.

Who Cannot Join the Study?

Patients who are not critically ill with septic shock. Septic shock is a severe infection that causes dangerously low blood pressure.
Patients who do not have a high risk of acute kidney injury (AKI). AKI is a sudden decrease in kidney function.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they may need special protection or care.
Patients who do not meet other specific health criteria set by the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Pxzb Teico Hulwergp Uhjehccvqife	Sabadell	Spain
Hppaljhp Uopygnrdlbwfg Hhtyblub Tzqko y Pknmxq Iqfbpvuv Cnuzqx dehtrathcghrvsqtq (cvcy	Badalona	Spain
Hhfvpits Vjcq dxnbmlsx	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	03.02.2025

Trial locations

Investigated drugs:

Human Serum Albumin

Human Albumin is a protein solution used in this trial to help improve kidney function in critically ill patients who are experiencing septic shock. The goal is to see if infusing human albumin can prevent severe kidney injury in these patients during the first week after septic shock begins.

Investigated diseases:

Septic Shock – A severe and widespread infection that leads to dangerously low blood pressure and organ dysfunction. It occurs when the body’s response to infection causes injury to its own tissues and organs. The condition progresses rapidly, often requiring immediate medical intervention to stabilize the patient. It can lead to multiple organ failure if not managed promptly.

Acute Kidney Injury – A sudden episode of kidney failure or damage that happens within a few hours or days. It causes waste products to build up in the blood, making it hard for the kidneys to maintain the right balance of fluid in the body. The condition can range from mild dysfunction to complete kidney failure. It is often reversible with timely treatment, but can progress to chronic kidney disease if not addressed.

Trial ID:

2024-518475-58-00

Protocol code:

ALBUMIR-AKI

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effect of Human Serum Albumin in Critically Ill Patients with Septic Shock at High Risk of Acute Kidney Injury

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?