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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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
Hospital Clinic de Barcelona
Barcelona, Catalonia, Spain
Hospital Moises Broggi
Barcelona, Catalonia, Spain
Hospital Parc Taulí
Sabadell, Catalonia, Spain
Resolution of hyponatremia
defined as an increase in serum sodium of more than 5 mEq/L with a final value \> 130 mEq/L
Time frame: for at least 48 consecutive hours during the 10-day treatment
partial resolution of hyponatremia
defined as an increase in serum sodium of more than 5meq/L with a final value below 130meq/L,
Time frame: maintained for at least 48 consecutive hours during the 10-day treatment period.
Evaluation of systemic hemodynamics
mean arterial pressure
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
measurement of creatinine levels
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
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).
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
PHES questionnaire
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).
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Effects on brain water content
performance of aMagnetic Resonance Spectroscopy (MRS)
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
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).
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
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).
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
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).
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.
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
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.
Time frame: 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
Time frame: visit day 1,2,3,4,5,6,7,8,9,28 and 90