Resuscitation Methods for Acute Kidney Injury in Liver Cirrhosis

(RAKI-VAGA Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Oxygen, Shock, Allergy, Encephalopathy, others

Trial Summary

What is the purpose of this trial?

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? Patients will be randomly assigned where their treating teams will receive a VAGA-based recommendation or a standard of care IV albumin recommendation.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, certain medications like vasoconstrictors for AKI treatment are allowed, so it's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment for resuscitation in acute kidney injury in liver cirrhosis?

Research suggests that albumin infusion may be beneficial for patients with liver cirrhosis, especially in conditions like large-volume paracentesis and hepatorenal syndrome, due to its clinical benefits shown in trials. Additionally, albumin has been found to be superior to saline in certain settings, and its use is recommended when other resuscitation methods have been exhausted. ^{1 2 3 4 5}

Is the use of albumin and crystalloids safe for resuscitation in humans?

The use of albumin for resuscitation is generally considered safe in humans, as shown in the SAFE study, except in cases of traumatic brain injury where it may increase mortality. Crystalloids are also widely used and considered safe, but they do not offer a survival benefit over colloids like albumin in critically ill patients. ^{1 2 3 4 6}

How does the treatment for acute kidney injury in liver cirrhosis differ from other treatments?

This treatment is unique because it uses intravenous albumin, which is a protein solution, to help manage fluid balance and improve blood pressure in patients with liver cirrhosis and acute kidney injury. Albumin is preferred over other fluids like saline due to its ability to better maintain blood volume and pressure, especially in patients with liver-related complications. ^{1 2 4 5 7}

Research Team

Eligibility Criteria

This trial is for patients with liver cirrhosis who have developed acute kidney injury. Participants should not be receiving any other treatments that could affect the study results, and they must be able to follow the trial procedures.

Inclusion Criteria

I have been diagnosed with advanced liver disease.

I am 18 years old or older.

I am currently admitted to a hospital.

Exclusion Criteria

I have received more than 200 grams of albumin during my current hospital stay.

I needed 3 or more blood transfusions due to severe bleeding in the last 2 days.

Pregnant or nursing status

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a VAGA-based recommendation or standard of care IV albumin for volume resuscitation

2 days

1 visit (in-person)

Initial Follow-up

Participants are assessed for primary efficacy and feasibility outcomes, including grams of albumin and adherence to guidance

48 hours

1 visit (in-person)

Extended Follow-up

Participants are monitored for safety and efficacy outcomes, including AKI response, vital status, and liver transplant status

Up to 90 days

Assessments at hospital discharge and 90 days post-randomization

Treatment Details

Interventions

• Recommendation: Resuscitation with Crystalloid (Fluid Resuscitation)
• Recommendation: Standard of Care IV Albumin (Fluid Resuscitation)

Trial Overview The study compares two methods of giving IV fluids in cirrhosis patients with acute kidney injury: a Volume Assessment Guidance Algorithm (VAGA) recommendation versus standard care with IV albumin. Patients are randomly assigned to one of these approaches.

Participant Groups

Group I: VAGA Group Experimental Treatment 3 Interventions

This group will receive an algorithm-based recommendation based on the 2024 Acute Disease Quality Initiative (ADQI)/International Club of Ascites (ICA) joint consensus meeting on AKI in cirrhosis, which recommends a personalized approach to AKI in cirrhosis in order to avoid volume overload. This includes balanced crystalloids as first-line resuscitative fluids unless there is a patient-specific indication for an alternative colloid (e.g. blood for gastrointestinal bleeding, IV albumin for spontaneous bacterial peritonitis or suspicion of hepatorenal syndrome), or no further resuscitation.

Group II: Standard of Care Placebo Group 1 Intervention

This group will receive a recommendation based on the 2021 American Association for the Study of Liver Diseases (AASLD) and 2018 European Association for the Study of the Liver (EASL) clinical practice guidelines, which recommends a 1 g/kg/d IV albumin (maximum 100 g/day) IV albumin over 2 days as an initial resuscitation approach for patients with AKI and cirrhosis.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3066

Patients Recruited

13,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2513

Patients Recruited

4,366,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decompensated Cirrhosis and Fluid Resuscitation. Maynard, E.[2017]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]. Maiwall, R., Kumar, A., Pasupuleti, SSR., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crystalloids versus colloids for resuscitation in shock. Waikar, SS., Chertow, GM.[2019]

The SAFE study indicates that using albumin for volume therapy is generally safe, although hypo-oncotic albumin should be avoided in cases of traumatic brain injury.

Albumin is recommended for specific conditions like liver cirrhosis and large-volume paracentesis due to proven clinical benefits, but more research is needed to establish its efficacy in broader applications, such as septic shock.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Use of albumin : State of the art]. Mayerhöfer, T., Wiedermann, CJ., Joannidis, M.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identification of indications for albumin administration in septic patients with liver cirrhosis. Hu, W., Chen, H., Ma, C., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Albumin is a blood product too - is it safe for all patients? Myburgh, JA., Finfer, S.[2015]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice patterns and outcomes associated with intravenous albumin in patients with cirrhosis and acute kidney injury. Patidar, KR., Adibuzzaman, M., Naved, MA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Decompensated Cirrhosis and Fluid Resuscitation. [2017]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A randomized-controlled trial comparing 20% albumin to plasmalyte in patients with cirrhosis and sepsis-induced hypotension [ALPS trial]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Crystalloids versus colloids for resuscitation in shock. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Use of albumin : State of the art]. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Identification of indications for albumin administration in septic patients with liver cirrhosis. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Albumin is a blood product too - is it safe for all patients? [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Practice patterns and outcomes associated with intravenous albumin in patients with cirrhosis and acute kidney injury. [2022]