Spotlight on albumin in cirrhosis

An open-label randomized trial looked at long-term albumin administration in patients with decompensated disease, and another evaluated the use of IV albumin in hospitalized patients with cirrhosis and hyponatremia at admission.

Two recent studies reported favorable outcomes of administering albumin in patients with cirrhosis.

The first study, published online on May 31 by The Lancet, was an open-label randomized trial of long-term albumin administration in patients with decompensated cirrhosis.

At 33 hospitals in Italy, researchers randomly assigned 431 patients with cirrhosis and uncomplicated ascites who were treated with an anti-aldosteronic drug (≥200 mg/d) and furosemide (≥25 mg/d) to receive either standard medical treatment (n=213) or standard medical treatment plus an intravenous infusion of human albumin (40 g twice weekly for 2 weeks, then 40 g weekly; n=218) for up to 18 months. The primary endpoint was mortality at 18 months.

Overall 18-month survival was significantly higher in the group that received albumin in addition to standard medical treatment than in the control group (Kaplan-Meier estimates, 77% vs. 66%; P=0.028), resulting in a 38% reduction in the mortality hazard ratio (hazard ratio, 0.62; 95% CI, 0.40 to 0.95).

The albumin group also had significantly reduced incidence rates of paracentesis and complications such as refractory ascites, spontaneous bacterial peritonitis or other bacterial infections, episodes of renal dysfunction, hepatorenal syndrome type 1, and hepatic encephalopathy grades 3 and 4.

The study authors noted limitations, such as the trial's open-label design and the fact that weekly albumin administration led patients in the intervention group to be seen by nurses more frequently than those receiving usual care. They wrote that the results are clinically relevant and “might prompt a change in [albumin] use in decompensated cirrhosis from targeting specific complications to a more comprehensive approach aimed at slowing down the progression of the disease.”

In the second study, researchers assessed 1,126 hospitalized patients with cirrhosis and hyponatremia at admission (sodium level <130 mEq/L) in the North American Consortium for End-Stage Liver Disease cohort. They analyzed hyponatremia resolution (sodium level ≥135 mEq/L) in those who received intravenous albumin (mean, 225 g; n=777) compared to those who did not (n=349).

Results of the industry-supported study were published online on June 8 by the American Journal of Gastroenterology.

Despite having significantly higher admission MELD scores, higher serum creatinine levels, lower admission sodium levels, and lower mean arterial pressure, patients who received albumin had higher rates of hyponatremia resolution (69.4% vs. 61.4%; P=0.009; odds ratio, 1.43 [95% CI, 1.09 to 1.86]) than those who did not. This difference remained significant after adjustment for baseline sodium levels and renal function (85.41% vs. 44.78%, P=0.006; odds ratio, 1.50 [95% CI, 1.13 to 2.00]). Resolution of hyponatremia was significantly associated with better 30-day survival (P=0.042).

The study authors noted that their analysis is limited by the use of albumin for indications other than hyponatremia. They added that they did not track daily withdrawal or dosage of lactulose and diuretics, which can affect sodium levels.