Evidence for Human Albumin Solution Use in Clinical Practice
Human albumin solution is not recommended as first-line therapy for most clinical scenarios due to lack of mortality benefit, high cost, and potential adverse effects. 1
Current Evidence-Based Indications
Strong Evidence for Use (Recommended)
- Liver Disease Complications:
Weak or Conditional Evidence (Second-Line Use)
Critical Care Settings:
Dialysis-Related:
- Intradialytic hypotension: Limited evidence for 25% albumin in patients with serum albumin <30 g/L 1
Other Potential Uses:
- Toxic epidermal necrolysis
- Severe refractory edema with hypoalbuminemia not responding to other treatments 2
Not Recommended (Evidence Against Use)
- Hypoalbuminemia correction without specific indications 1, 2, 3
- First-line volume replacement in most critically ill adults 1
- Nutritional supplementation 2
- Routine use in cardiovascular surgery 1
- General hypovolemia management when crystalloids are adequate 1, 4
Historical Context and Evolution of Evidence
The evidence regarding albumin has evolved significantly over time. Early Cochrane reviews (2002) suggested potential harm with a relative risk of death of 1.52 (95% CI 1.17-1.99) 5. Later reviews (2004) showed a more neutral effect with a pooled relative risk of 1.04 (95% CI 0.95-1.13) 4.
The most recent comprehensive guidelines (2024) from the International Collaboration for Transfusion Medicine Guidelines provide conditional recommendations against albumin as first-line therapy in most scenarios, based on moderate-quality evidence 1.
Practical Considerations
Adverse Effects
- Fluid overload
- Hypotension
- Hemodilution requiring RBC transfusion
- Anaphylaxis
- Peripheral gangrene from dilution of natural anticoagulants 1
Cost Considerations
- Expensive (approximately $130/25g in USD) 1
- Annual cost for thrice-weekly use in maintenance hemodialysis estimated at $20,000 per patient 1
- Manufactured from large volumes of plasma with limited supply 1, 6
Special Populations
Critically Ill Children
Evidence suggests potential harm in children with febrile illness and hypoperfusion when either albumin or crystalloid boluses were compared to no bolus strategy 1.
Patients with Cirrhosis
The strongest evidence supports albumin use in this population, particularly for complications like spontaneous bacterial peritonitis, hepatorenal syndrome, and large-volume paracentesis 1, 2, 6.
Future Directions
Five ongoing RCTs enrolling over 4,800 patients are expected to provide additional clarity on albumin's role in:
- Intensive care patients with infection
- High-risk adult cardiac surgery
- Acute kidney injury requiring replacement therapy
- Outpatients with decompensated cirrhosis 1
Implementation of evidence-based guidelines in hospitals can effectively reduce inappropriate albumin use while ensuring it remains available for indications with proven benefit 2.