Albumin for Management of Hypervolemic Hyponatremia (AlbuCAT)

NCT03941405 | Completed Phase 2

• 1 other identifier: 2019-000302-29
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Resolution of hyponatremia

  defined as an increase in serum sodium of more than 5 mEq/L with a final value \> 130 mEq/L

  for at least 48 consecutive hours during the 10-day treatment

Secondary Outcomes (12)

• partial resolution of hyponatremia

  maintained for at least 48 consecutive hours during the 10-day treatment period.

• Evaluation of systemic hemodynamics

  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

  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

  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

  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).

Study Arms (2)

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.

Drug: Albumin treatment

Interventions

Albumin treatment 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

Also known as: Human Albumin Grifols 200 g/l, solution for infusion

Albumin treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients included into the study must meet all the following criteria:

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (3)

Hospital Clinic de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital Moises Broggi

Barcelona, Catalonia, Spain

Location

Hospital Parc Taulí

Sabadell, Catalonia, 08208, Spain

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Albumins; Solutions

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: March 28, 2019
• First Posted: May 8, 2019
• Study Start: February 1, 2020
• Primary Completion: December 28, 2024
• Study Completion: January 30, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

ES (3)