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What are the benefits and risks of albumin in people with cirrhosis of the liver and bacterial infection?

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Key messages

Albumin versus no intervention

  • We are very uncertain about the effects of albumin on death due to any cause, unwanted serious events, complications of cirrhosis (advanced liver damage), and severe infection.

  • We are very uncertain whether albumin may reduce kidney damage.

Albumin versus other intravenous fluids (such as synthetic colloids or saline solutions)

  • We are very uncertain about the effects of albumin on death due to any cause, on kidney damage, or whether albumin increases serious unwanted effects or reduces septic shock.

  • More larger studies are required where the people and investigators are not aware of the treatments being used. These studies should include children. They also need to investigate differences in the albumin used and compare it with other types of intravenous fluids.

What is cirrhosis of the liver?

Cirrhosis is scarring of the liver, which develops over time. Complications of cirrhosis may include the appearance of fluid in the tummy, impaired brain function, or yellowing of the skin. People with liver cirrhosis are prone to bacterial (tiny germs that can make you sick) infections. Complications of advanced cirrhosis are frequent and can lead to death. If treated on time, complications and death can be reduced.

What did we want to find out?

To assess the benefits and risks of human albumin (a protein found in the blood), in addition to antibiotics, in people with liver cirrhosis and bacterial infections compared to no intervention, placebo (dummy pill), or other intravenous fluids (sterile products given within the vein to increase or retain the volume of fluid in the organ system responsible for transporting blood through vessels to and from all parts of the body (that is, the circulatory system).

What did we do?

We searched for studies that tested albumin in people of any age with cirrhosis and infections. We collected and summarised the data needed for our analysis. We studied, among others, how similar the study participants were, whether all participants completed the studies, and what kind of data were reported and how they were measured. We rated our confidence in the evidence based on factors like the study methods used to conduct the studies. We rated the certainty of evidence in the studied outcomes (that is, the results collected at the longest time point) as very low or low.

What did we find?

We found 11 studies with 1273 adults with an average age of 54 years (no children). All the people involved received antibiotics. Albumin was administered through a vein. In eight studies, albumin was compared with no treatment. In three studies, albumin was compared with different types of intravenous fluids. Five studies included 388 people with cirrhosis and an infection of the peritoneum (a membrane that lines the inside of the tummy), called spontaneous bacterial peritonitis. Four studies included 477 people with cirrhosis and infections in various body parts, like the lungs, urinary tract (where urine is produced), and skin. Two studies enroled 408 people with cirrhosis who had infections in different body areas along with dangerously low blood pressure due to a severe infection.

One trial was conducted in eight European countries, and ten were conducted in India, Spain, China, France, Egypt, and Taiwan. The studies took place in a clinic or university hospital. About half the studies were short-term, lasting for up to one month, and the other half lasted for three months.

Ten studies were either free from for-profit support or did not report the sources of support, and one declared partial private support, delivering albumin vials.

Main results

We identified problems in the way the studies were performed, which reduced the certainty of the results.

Albumin versus no intervention
It is either uncertain or very uncertain whether albumin affects death due to any cause, unwanted serious events, complications of cirrhosis, and septic shock (that is, decreased blood pressure in severe infection with organ damage). It is very uncertain whether albumin may reduce the risk of kidney damage. The studies did not report data on well-being.

Albumin versus other intravenous fluids

It is very uncertain whether albumin affects death due to any cause or kidney damage, or whether albumin may increase serious unwanted events. It is uncertain whether albumin may reduce septic shock. The studies did not report data on well-being or on other complications of cirrhosis.

For both comparisons, we could not assess the effect of albumin regarding the site of infection.

What are the limitations of the evidence?

We are very unconfident of the evidence because there were problems with the design and conduct of the studies, and the data for a meaningful analysis of the studied outcomes were insufficient or lacking. Therefore, we cannot be sure of the effects of albumin compared with no intervention, or compared with other intravenous fluid.

How up-to-date is this evidence?

The evidence is up-to-date to 20 August 2025.

研究目的

To assess the benefits and harms of intravenous administration of human albumin in people with liver cirrhosis and bacterial infections versus no intervention, placebo, or other intravenous fluids.

检索策略

We identified randomised clinical trials (RCTs) through electronic searches in the Cochrane Hepato‐Biliary Group Controlled Trials Register, CENTRAL, MEDLINE, Embase, LILACS, Science Citation Index Expanded, and Conference Proceedings Citation Index–Science. We searched online clinical trial registries for unpublished or ongoing trials and checked reference lists for additional trials (latest search date: 20 August 2025).

作者结论

Due to the very low certainty and low certainty of evidence, we are either uncertain or very uncertain about the effect of albumin, compared with no intervention, on all-cause mortality, serious adverse events, kidney impairment, acute liver decompensation, acute-on-chronic liver failure, and septic shock.

Due to very low certainty of evidence, we are very uncertain about the effect of albumin, compared with other intravenous fluids, on all-cause mortality or kidney impairment. The evidence is also very uncertain whether albumin increases serious adverse events. Due to low-certainty evidence, we are uncertain whether albumin reduces septic shock. No trial in this comparison reported data on acute liver decompensation and acute-on-chronic liver failure.

Data on health-related quality of life were lacking.

Though clinically relevant, we could not assess the effect of albumin in regard to the site and stage of infection due to insufficient data.

We lack trials in children.

资助

None.

注册

Protocol available via 10.1002/14651858.CD014636

引用文献
Simonetti RG, Perricone G, Nikolova D, Menon S, Gluud C. Albumin for people with liver cirrhosis and bacterial infections. Cochrane Database of Systematic Reviews 2026, Issue 7. Art. No.: CD014636. DOI: 10.1002/14651858.CD014636.pub2.

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