Albumin for Management of Hypervolemic Hyponatremia (AlbuCAT)

NCT ID: NCT03941405

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2025-01-30

Brief 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

Conditions

Hyponatremia With Excess Extracellular Fluid Volume; Cirrhosis, Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

No treatment

No treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Albumin treatment

one dose per day of a 40g albumin g/l gram(s)/litre for 10 days.

Group Type: EXPERIMENTAL

Albumin treatment

Intervention Type: DRUG

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

Interventions

Albumin treatment

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

Intervention Type: DRUG

Other Intervention Names

Human Albumin Grifols 200 g/l, solution for infusion

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

1. Patients with Acute kidney injury 1B or higher;

2. 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.

3. Previous kidney or liver transplant;

4. Active infection apart from spontaneous bacterial peritonytis based on positive culture (blood, urine, sputum or other samples) or by the following criteria:

1. Urinary infections: signs of systemic inflammation and more than 10 leukocytes per high-power field in urine;

2. Pneumonia: compatible symptoms (cough, purulent sputum, chest pain, shortness of breath) and presence of new infiltrates on chest x-ray;

3. Skin/soft tissue infection: physical exam findings of swelling, erythema, heat and tenderness in the skin;

4. Acute cholangitis: signs of systemic inflammation1, compatible symptoms (right upper quadrant pain and jaundice) and radiological data of biliary obstruction, analytical data of cholestasis;

5. 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.

5. Spontaneous bacterial peritonitis.

6. Hypo or hyperthyroidism not controlled under adequate treatment.

7. 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.

8. Hepatocellular carcinoma beyond Milan criteria.

9. Severe alcoholic hepatitis defined by Maddrey score ≥32 and/or MELD score ≥ 20

10. ACLF with two or more organ failures

11. Treatment with diuretics (furosemide or spironolactone), albumin infusion, somatostatin or terlipresin in the previous 3 days.

12. Symptomatic hyponatremia (manifested by cardio-respiratory distress, abnormal and deep somnolence, seizures or coma) with serum sodium below 120 mEq/L.

13. Previous known hypersensitivity to human albumin

14. Refuse to give informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Clinic per a la Recerca Biomédica

OTHER

Sponsor Role: lead

Responsible Party

Anna Cruceta

Project manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Clinic de Barcelona

Barcelona, Catalonia, Spain

Hospital Moises Broggi

Barcelona, Catalonia, Spain

Hospital Parc Taulí

Sabadell, Catalonia, Spain

Countries

Spain

Other Identifiers

2019-000302-29

Identifier Type: -

Identifier Source: org_study_id