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Daily albumin infusions do not provide significant health benefits to patients with advanced liver disease beyond "standard care". This is evident from a large-scale, multicenter study conducted by UCL researchers.
Albumin is a protein made in the liver that prevents fluid from the bloodstream from reaching other tissues in the body and carries various substances such as hormones and enzymes around the body. In people with liver disease, low albumin levels have been linked to an increased risk of death in hospitalized patients with cirrhosis, and laboratory studies have shown that albumin has anti-inflammatory effects. Hence, albumin infusions are considered the best fluid for patients with cirrhosis and are an essential part of clinical care.
Professor Alastair O'Brien (UCL Department of Medicine) explained the ATTIRE study as follows: "Acutely hospitalized patients with cirrhosis are very ill; infections and increased systemic inflammation lead to very high death rates in those affected.
"Albumin infusions have been used with great enthusiasm by liver specialists for the past 70 years. It is widely believed that it is best at reducing the abnormal fluid build-up caused by cirrhosis, and preclinical studies support an anti-inflammatory role. However, albumin is significantly more expensive when compared to other fluids There are manufacturing deficiencies and the critical lack of confirmatory large-scale clinical studies to support their use.
"To establish a better evidence base, we investigated whether increasing serum albumin levels of 30 g / L or more in these patients with repeated daily infusions of human albumin solution compared to standard UK albumin would reduce the incidence of infections and kidney dysfunction and death. "
In the ATTIRE study published in the New England Journal of Medicine, 777 patients with acute decompensated cirrhosis of the liver were randomly placed into one of two groups. The study was conducted in 35 locations in the UK and 90% of patients had alcohol as the leading cause of cirrhosis.
In the experimental arm of the study known as the "Target Albumin Group", 380 patients received daily infusions of human albumin solution to increase blood levels to 30 grams of albumin per liter or more for up to 14 days or more until discharge.
In the other group, 397 patients received “standard care,” which could include albumin infusions to drain ascites (fluid in the abdomen) or kidney failure for up to 14 days or until discharge. Standard care varies by patient based on a doctor’s judgment, and prescribed albumin levels are far lower than the experimental arm of the study.
The target albumin group received about ten times more albumin, and serum albumin levels in this group rose to 30 grams per liter or more within three days, while levels in the standard care group remained at 25 grams per liter or less. To determine whether the targeted albumin treatment had worked, the primary endpoint of the study was: infection, kidney failure, or death between the 3rd and 15th day after starting treatment.
In the albumin target group, 113 of 380 patients (29.7%) developed one of the primary endpoints: infection, renal impairment, or death. In the standard care group there were 120 of 397 patients (30.2%). Of all hospitalized patients, one third (32.3%) died within six months of starting treatment.
The researchers concluded that there was no evidence of any benefit for targeted albumin. In addition, these patients experienced more serious or life threatening serious adverse events (i.e. pulmonary edema or ascites) in the target albumin group.
Professor O'Brien, also clinical director of the UCL Comprehensive Clinical Trials Unit, added, "Our large, high-quality, randomized study showed no benefit from targeted albumin infusions, and those given higher doses actually had more serious adverse events The data support both the need to abandon this costly therapy and a reassessment of our understanding of this complex condition – after all, the high mortality rates in these patients do not appear to have changed in 20 years. This calls for renewed focus to prevent major causes of liver disease, excessive alcohol consumption and obesity. "
Cirrhosis of the liver
Liver disease is the fifth leading cause of death in the UK and the only one in the top 10 currently on the rise, mainly due to excessive alcohol consumption and rising obesity.
Every year around 70,000 people with liver disease are admitted to hospitals in England. Of these roughly 22,000 patients, alcoholic liver disease is a problem, and this number is increasing.
It is estimated that around 9,000 people die from cirrhosis each year in the UK. The average survival of people with decompensated (advanced) cirrhosis is two years. Infection is a common cause of death because patients have a weakened immune system. However, there is no effective strategy to improve this.
The condition is tough on health care professionals, with frequent hospitalizations to treat ascites (abnormal build-up of fluid in the abdomen) and other complications such as internal bleeding and brain complications such as encephalopathy.
This study included researchers from the UCL Institute for Liver and Digestive Health, the UCL Comprehensive Clinical Trials Unit, and the UCL Division of Medicine.
Long-term treatment of decompensated cirrhosis with human albumin improves survival
Louise China, Nick Freemantle, Ewan Forrest, Yiannis Kallis, Stephen Ryder, Gavin Wright, Andrew Portal, Natalia Becares Salles, Derek Gilroy and Alastair O & # 39; Brien for the ATTIRE Trial Investigators, a randomized study of albumin infusions in hospitalized patients with cirrhosis & # 39; New England Journal of Medicine (2021). DOI: 10.1056 / NEJMoa2022166
University College London
Albumin Provides No Benefit to Hospital Patients With Advanced Liver Disease (2021 Mar 3)
accessed on March 3, 2021
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