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New treatment option for Cirrhosis, Liver
Official title Initial Resuscitation for Acute Kidney Injury in Cirrhosis
ClinicalTrials.gov ID: NCT06525623
What this study is testing
- What it's testing
- The goal of this interventional study is to evaluate two strategies for how to provide intravenous (IV) fluids for treating patients with acute kidney injury (AKI) in cirrhosis. The main question it aims to answer is: what is the safety, efficacy, and feasibility of providing a recommendation to use a Volume Assessment Guidance Algorithm (VAGA) or give standard of care doses of IV albumin?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult age 18 years or greater
- Signed informed consent form (ICF) by any subject capable of giving consent, or, when the subject is not capable of giving consent, by their legally...
- Admitted to the hospital
- Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).
- Presence of acute kidney injury (AKI) as defined by International Club of Ascites (ICA) criteria, defined as SCr increase of ≥0.3 mg/dL within 48...
You likely can't join if
- Requiring \>2 liters (L) supplemental oxygen at the time of screening.
- In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).
- Allergy or other contraindication to IV albumin administration.
- Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.
- Patient and/or legally authorized representative unable to provide informed consent.
- Hepatic encephalopathy grade 3 or 4 at the time of screening.
See the full eligibility criteria
- Adult age 18 years or greater
- Signed informed consent form (ICF) by any subject capable of giving consent, or, when the subject is not capable of giving consent, by their legally authorized representatives prior to initiation of any study procedures.
- Admitted to the hospital
- Diagnosis of decompensated cirrhosis (either prior to admission or new diagnosis on admission).
- Presence of acute kidney injury (AKI) as defined by International Club of Ascites (ICA) criteria, defined as SCr increase of ≥0.3 mg/dL within 48 hours or ≥50% increase from baseline which is known or presumed to have...
- Requiring \>2 liters (L) supplemental oxygen at the time of screening.
- In shock requiring vasopressors (vasoconstrictors for the treatment of AKI such as terlipressin, midodrine, and octreotide are allowed).
- Allergy or other contraindication to IV albumin administration.
- Death, liver transplant, or renal replacement therapy (RRT) expected within 48 hours.
- Patient and/or legally authorized representative unable to provide informed consent.
- Hepatic encephalopathy grade 3 or 4 at the time of screening.
- Already received \>200 g albumin during admission at the time of screening.
- Severe, active bleeding requiring 3 or more units of red blood cell transfusion in the 48 hours prior to screening.
- Admission to the intensive care unit at the time of screening.
- Mechanical ventilation at the time of screening.
- Presence of New York Heart Association (NYHA) class 3-4 symptoms of congestive heart failure at the time of screening.
- History of prior liver or kidney transplant.
- Pregnant or nursing status
- Any condition, in the opinion of the investigator, that could confound or interfere with the safe completion of study activities.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.