Hyponatremia With Excess Extracellular Fluid VolumePhase 2AlbuCATNCT03941405

Albumin for Management of Hypervolemic Hyponatremia (AlbuCAT)

A Phase 2 study testing Albumin treatment in people with Hyponatremia With Excess Extracellular Fluid Volume and Cirrhosis, Liver, run by Fundacion Clinic per a la Recerca Biomédica at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hyponatremia With Excess Extracellular Fluid Volume, Cirrhosis, Liver
What is being tested?: Albumin treatment
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 3 sitesSpain
Study dates: 1 Feb 2020to 30 Jan 2025
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients included into the study must meet all the following criteria:
This study will include patients with liver cirrhosis and hypervolemic hyponatremia (serum sodium<130 mEq/L) admitted to hospital for any decompensation of the disease. Patients will be enrolled if hyponatremia persists after 3 days of diuretic withdrawal and fluid restriction. Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner. Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.

Who cannot join

Patients with Acute kidney injury 1B or higher;
Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate <60ml/min for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate > 30 mg/24h; Albumin-to-creatinine ratio > 30 mg/g), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging.
Previous kidney or liver transplant;
Active infection apart from spontaneous bacterial peritonytis based on positive culture (blood, urine, sputum or other samples) or by the following criteria:
Urinary infections: signs of systemic inflammation and more than 10 leukocytes per high-power field in urine;
Pneumonia: compatible symptoms (cough, purulent sputum, chest pain, shortness of breath) and presence of new infiltrates on chest x-ray;

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Skin/soft tissue infection: physical exam findings of swelling, erythema, heat and tenderness in the skin;
Acute cholangitis: signs of systemic inflammation1, compatible symptoms (right upper quadrant pain and jaundice) and radiological data of biliary obstruction, analytical data of cholestasis;
Suspected bacterial infection: signs of systemic inflammation1 but no identifiable origin of this infection (polymorphonuclear cells in ascitic and pleural fluid < 250/mm3, normal urine sediment and chest Xray) After 48 hours of appropriate antibiotic treatment patients can be enrolled.
Spontaneous bacterial peritonitis.
Hypo or hyperthyroidism not controlled under adequate treatment.
Associated heart failure, defined as a New York Heart Association (NYHA) classification III or IV or heart failure with reduced ejection fraction (LVEF<40%). Previously known structural cardiomyopathy including ischemic cardiomyopathy, restrictive cardiomyopathy or valvular cardiomyopathy.
Hepatocellular carcinoma beyond Milan criteria.
Severe alcoholic hepatitis defined by Maddrey score ≥32 and/or MELD score ≥ 20
ACLF with two or more organ failures
Treatment with diuretics (furosemide or spironolactone), albumin infusion, somatostatin or terlipresin in the previous 3 days.
Symptomatic hyponatremia (manifested by cardio-respiratory distress, abnormal and deep somnolence, seizures or coma) with serum sodium below 120 mEq/L.
Previous known hypersensitivity to human albumin
Refuse to give informed consent

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036
Hospital Moises Broggi
Barcelona, Catalonia
Hospital Parc Taulí
Sabadell, Catalonia, 08208

Other trials in Spain

About this study

Official title: Albumin for Management of Hypervolemic Hyponatremia in Patients With Decompensated Cirrhosis. A Proof of Concept Study.

resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period

Conditions: Hyponatremia With Excess Extracellular Fluid Volume, Cirrhosis, Liver
Being tested: Albumin treatment
Medical subject headings: Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Albumin treatmentDrug
Also called Human Albumin Grifols 200 g/l, solution for infusion
one dose per day of a 40g albumin g/l gram(s)/litre for 10 days. resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period

Study groups in NCT03941405
Study group	Role	What they receive
No treatment	No intervention	No treatment.
Albumin treatment	Experimental	one dose per day of a 40g albumin g/l gram(s)/litre for 10 days. Receives: Drug: Albumin treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Resolution of hyponatremia
defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L
Measured: for at least 48 consecutive hours during the 10-day treatment

Secondary outcomes (12)

partial resolution of hyponatremia
defined as an increase in serum sodium of more than 5meq/L with a final value below 130meq/L,
Measured: maintained for at least 48 consecutive hours during the 10-day treatment period.
Evaluation of systemic hemodynamics
mean arterial pressure
Measured: levels at day 0, at day 5 and at day 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days) of the study period.
kidney function
measurement of creatinine levels
Measured: levels at day 0, 5 and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects on the inflammatory profile
evaluation of PCR of plasma cytokines by using a multiplex kit including plasmatic cytokines related to immune response. This multiplex test will be performed at day 0 and day 10 of the study period (or at the end of study in case of early termination).
Measured: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects on neurocognitive function and quality
PHES questionnaire
Measured: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects on brain water content
performance of aMagnetic Resonance Spectroscopy (MRS)
Measured: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects of albumin administration on liver phagocytic capacity
Effects of albumin administration on liver phagocytic capacity as assessed by performance of hepatic SPECT with 99mTc-phytate at day 0 and 10 (or at the end of study in case of early termination).
Measured: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects on phagocytic capacity and inflammatory response of peripheral monocytes
Effects on phagocytic capacity and inflammatory response of peripheral monocytes will be assessed by performance specific tests (Phagotest and Phagoburst) evaluating the in vitro phagocytic capacity and burst response. Monocytes will be isolated and analysed at day 0 and at day 10 of the study period (or at the end of study in case of early termination).
Measured: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects of albumin administration of microbiome composition
Effects of albumin administration of microbiome composition as assessed by analysis of microbiome composition at day 0 and 10 of the study period (or at the end of study in case of early termination).
Measured: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects of albumin administration on development of infections, development of complications of cirrhosis and survival.
Effects of albumin administration on development of infections, development of complications of cirrhosis and survival.
Measured: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects of albumin administration on serum albumin levels
Effects of albumin administration on serum albumin levels assessed by measurement of mEq/L serum albumin levels at day 0, 5, 10, 28 and 90 of study period.
Measured: levels at day 0, 5, 10, 28 and 90 of study period.
evaluate treatment-related serious adverse events
To evaluate treatment-related serious adverse events during the treatment period
Measured: visit day 1,2,3,4,5,6,7,8,9,28 and 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202030 Jan 2025

First posted8 May 2019
Study start1 Feb 2020
Primary completion28 Dec 2024
Study completion30 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hyponatremia With Excess Extracellular Fluid VolumeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03941405
Sponsor's protocol ID: 2019-000302-29
Other IDs: 2019
Acronym: AlbuCAT
Status last verified: Feb 2025
First submitted: 28 Mar 2019
Last updated: 28 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Albumin for Management of Hypervolemic Hyponatremia in Patients With Decompensated Cirrhosis. A Proof of Concept Study.
ClinicalTrials.gov ID: NCT03941405
Acronym / sponsor ID: AlbuCAT / 2019-000302-29
Conditions: Hyponatremia With Excess Extracellular Fluid Volume, Cirrhosis, Liver
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
Study start: 1 Feb 2020 (actual)
Primary completion: 28 Dec 2024 (actual)
Study completion: 30 Jan 2025 (actual)
First posted: 8 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
No treatment	No intervention	–No treatment.
Albumin treatment	Experimental	Drug: Albumin treatmentone dose per day of a 40g albumin g/l gram(s)/litre for 10 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients included into the study must meet all the following criteria:
This study will include patients with liver cirrhosis and hypervolemic hyponatremia (serum sodium<130 mEq/L) admitted to hospital for any decompensation of the disease. Patients will be enrolled if hyponatremia persists after 3 days of diuretic withdrawal and fluid restriction. Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner. Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.

Key exclusion criteria (19 listed)

Patients with Acute kidney injury 1B or higher;
Chronic kidney disease grade 3a or higher, defined as glomerular filtration rate <60ml/min for three months and markers of kidney damage (one or more): Albuminuria (Albumin excretion rate > 30 mg/24h; Albumin-to-creatinine ratio > 30 mg/g), Urine sediment abnormalities, Electrolyte and other abnormalities due to tubular disorders, Electrolyte and other abnormalities due to tubular disorders, Abnormalities detected by histology or Structural abnormalities detected by imaging.
Previous kidney or liver transplant;
Active infection apart from spontaneous bacterial peritonytis based on positive culture (blood, urine, sputum or other samples) or by the following criteria:
Spontaneous bacterial peritonitis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Albumin treatmentAlso: Human Albumin Grifols 200 g/l, solution for infusionone dose per day of a 40g albumin g/l gram(s)/litre for 10 days. resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period	Drug	Albumin treatment

Primary outcome

Resolution of hyponatremia
Time frame: for at least 48 consecutive hours during the 10-day treatment
defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L

12 secondary outcomes

partial resolution of hyponatremia
Time frame: maintained for at least 48 consecutive hours during the 10-day treatment period.
Evaluation of systemic hemodynamics
Time frame: levels at day 0, at day 5 and at day 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days) of the study period.
kidney function
Time frame: levels at day 0, 5 and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects on the inflammatory profile
Time frame: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects on neurocognitive function and quality
Time frame: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects on brain water content
Time frame: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects of albumin administration on liver phagocytic capacity
Time frame: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects on phagocytic capacity and inflammatory response of peripheral monocytes
Time frame: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects of albumin administration of microbiome composition
Time frame: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects of albumin administration on development of infections, development of complications of cirrhosis and survival.
Time frame: levels at day 0, and 10 (or at the end of study in case of early termination due to primary endpoint reach from day 0 up to 10 days).
Effects of albumin administration on serum albumin levels
Time frame: levels at day 0, 5, 10, 28 and 90 of study period.
evaluate treatment-related serious adverse events
Time frame: visit day 1,2,3,4,5,6,7,8,9,28 and 90

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of hyponatremia (time frame: for at least 48 consecutive hours during the 10-day treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941405.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.