Albumin infusions did not result in statistically significant differences in predefined study endpoints.
While previous studies show albumin provides anti-inflammatory properties of cirrhosis patients, there is a scarcity of larger clinical trials.
Whether targeting a serum albumin level of 30 g per liter or greater in this patient population with repeated daily infusions of 20% human albumin solution, compared to standard care, could reduce the incidences of infection, kidney dysfunction, and death is largely unknown.
A team, led by Louise China, PhD, Institute for Liver and Digestive Health, examined whether albumin is beneficial for hospitalized patients with decompensated cirrhosis who had a serum albumin level of less than 30 g per liter at enrollment.
In the randomized, multicenter, open-label, parallel-group trial, the investigators randomly assigned 777 patients to receive either targeted 20% human albumin solution for up to 14 days or until discharge or standard care.
Treatment commended within 3 days following admission.
Infection and increased systemic inflammation can cause organ dysfunction and death for patients with decompensated cirrhosis.
The investigators sought a composite primary endpoint of new infections, kidney dysfunction, or deaths between days 3-15 following treatment initiation.
The majority of patients in the study reported alcohol as the cause for cirrhosis.
A median total infusion of albumin of 200 g (interquartile range, 140-280) per patient was administered to the targeted albumin group (increasing the albumin level to ≥30 g per liter), as compared to a median of 20 g (interquartile range, 0-120) per patient administered to the standard-care group (adjusted mean difference, 143 g; 95% CI, 127-158.2).
Overall, the proportion of patients who met the primary endpoint did not significantly differ between the 2 groups.
In the targeted albumin group, 113 patients (29.7%) met the primary endpoint, while 120 individuals (30.2%) in the standard care group met the primary endpoint (aOR, 0.98; 95% CI, 0.71-1.33; P = 0.87).
In a time-to-event analysis where the researchers censored data at the time of discharge or at day 15, they found now significant between-group differences (HR, 1.04; 95% CI, 0.81-1.35).
In addition, more severe or life-threatening serious adverse events occurred in the albumin group than in the standard-care group.
“In patients hospitalized with decompensated cirrhosis, albumin infusions to increase the albumin level to a target of 30 g per liter or more was not more beneficial than the current standard care in the United Kingdom,” the authors wrote.
The Value of Exercise
In 2019, researchers found exercise might be especially beneficial for cirrhosis patients, reducing the risk of death.
The study, which was presented at Digestive Disease Week 2019 in San Diego, CA, found that physical activity was associated with a 73% lower risk of dying from liver disease after studying more than 117,000 people over a 26-year period.
While past studies and research have been limited, usually only assessing physical activity at one point or have had short follow-up periods. This study represented the first prospective study in a large US population to included updated measurements of physical activity over such a prolonged period. The longer study period allowed investigators to more accurately estimate the relationship between physical activity.
The study, “A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis,” was published online in the New England Journal of Medicine.