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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/20/2021.

Albumin for Management of Hypervolemic Hyponatremia (AlbuCAT)

Clinicaltrials.gov identifier NCT03941405

Recruitment Status Not yet recruiting

First Posted May 8, 2019

Last update posted February 5, 2020

Study Description

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

  • Condition or Disease:Hyponatremia With Excess Extracellular Fluid Volume
    Cirrhosis, Liver
  • Intervention/Treatment: Drug: Albumin treatment
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 52 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Albumin for Management of Hypervolemic Hyponatremia in Patients With Decompensated Cirrhosis. A Proof of Concept Study.
  • Estimated Study Start Date: July 2020
  • Estimated Primary Completion Date: July 2022
  • Estimated Study Completion Date: November 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Albumin treatment
one dose per day of a 40g albumin g/l gram(s)/litre for 10 days.
Drug: 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
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. partial resolution of hyponatremia [ Time Frame: maintained for at least 48 consecutive hours during the 10-day treatment period. ]
    defined as an increase in serum sodium of more than 5meq/L with a final value below 130meq/L,
  • 2. 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. ]
    mean arterial pressure
  • 3. 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). ]
    measurement of creatinine levels
  • 4. 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). ]
    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).
  • 5. 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). ]
    PHES questionnaire
  • 6. 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). ]
    performance of aMagnetic Resonance Spectroscopy (MRS)
  • 7. 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 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).
  • 8. 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 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).
  • 9. 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 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).
  • 10. 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 development of infections, development of complications of cirrhosis and survival.
  • 11. Effects of albumin administration on serum albumin levels [ Time Frame: levels at day 0, 5, 10, 28 and 90 of study period. ]
    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.
  • 12. evaluate treatment-related serious adverse events [ Time Frame: visit day 1,2,3,4,5,6,7,8,9,28 and 90 ]
    To evaluate treatment-related serious adverse events during the treatment period
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 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

Contacts and Locations
Contacts

Contact: Anna Cruceta 0034 93 2279838 acruceta@clinic.ub.es

Locations

Spain, Catalunya
Hospital Clinic de Barcelona
Barcelona

Spain, Catalunya
Hospital Moises Broggi
Barcelona

Spain, Catalunya
Hospital Parc Taulí
Sabadell

Sponsors and Collaborators

Fundacion Clinic per a la Recerca Biomédica

More Information
  • Responsible Party: Fundacion Clinic per a la Recerca Biomédica
  • ClinicalTrials.gov Identifier: NCT03941405 History of Changes
  • Other Study ID Numbers: 2019-000302-29
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: February 5, 2020
  • Last Verified: February 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Liver Cirrhosis
    Hyponatremia
    Fibrosis