Posted by Carla Rothaus
In the trial by China et al., did albumin infusions, as compared with standard care, improve outcomes in patients with decompensated cirrhosis?
Infection and increased systemic inflammation cause organ dysfunction and death in patients with decompensated cirrhosis. China et al. evaluated whether increasing the serum albumin level to 30 g per liter or more with the use of repeated daily infusions of albumin, as compared with standard care in the United Kingdom, would improve outcomes among hospitalized patients with decompensated cirrhosis. Read the NEJM Original Article here.
Q: What is the rationale for investigating the use of albumin in patients with cirrhosis?
A: Preclinical studies have shown an antiinflammatory effect of albumin in patients with cirrhosis; this finding suggests that infusions of albumin might limit systemic inflammation, prevent infections, reduce the risk of kidney dysfunction, and increase survival. A low serum albumin level has been associated with an increased risk of death among hospitalized patients who have cirrhosis and infections, and albumin infusions that increased serum levels to more than 30 g per liter have reduced systemic inflammation among patients with decompensated cirrhosis and have reduced the incidence of nosocomial infection among patients with cirrhosis who were hospitalized with nonspontaneous bacterial peritonitis infections.
Q: Have prior trials of albumin uniformly shown a benefit in patients with cirrhosis?
A: Clinical trials of albumin have shown conflicting results. A trial of albumin in patients with spontaneous bacterial peritonitis showed a benefit, but a trial involving patients with other infections did not, and the latter trial was terminated because of lethal pulmonary edema associated with albumin. A recent meta-analysis did not show that any interventions in patients with the hepatorenal syndrome reduced the incidence of death from any cause, and another recent meta-analysis did not show differences between albumin and other plasma expanders with respect to the incidence of death after large-volume paracentesis.
Morning Report Questions
Q: In the trial by China et al., did albumin infusions, as compared with standard care, improve outcomes in patients with decompensated cirrhosis?
A: In this trial, patients were randomly assigned to receive either targeted 20% human albumin solution for up to 14 days or until discharge, whichever came first, or standard care. The trial did not show a benefit of targeted albumin therapy over the current standard care. The primary end point was a composite of infection from any cause, kidney dysfunction, or death in hospitalized patients between trial day 3 and day 15. In the intention-to-treat analysis, a total of 113 of 380 patients (29.7%) in the albumin group and 120 of 397 patients (30.2%) in the standard-care group had a protocol-defined composite primary end-point event (adjusted odds ratio, 0.98; 95% CI, 0.71 to 1.33; P=0.87). There were no apparent benefits of the intervention with respect to the primary end point in any of the subgroups analyzed. There were no significant between-group differences in the incidence of death at 28 days, 3 months, and 6 months.
Q: What were some additional results of the trial by China et al.?
A: There was no evidence of significant between-group differences during treatment with respect to the development of new respiratory, cardiovascular, or cerebral dysfunction or the use of terlipressin. Also, there was no significant between-group difference in the duration of hospitalizations. There were more severe or life-threatening serious adverse events, especially pulmonary edema or fluid overload, in the albumin group than in the standard-care group.
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