Human Albumin
Overview
Human Albumin is a naturally occurring plasma protein that plays a central role in maintaining oncotic pressure and transporting hormones, drugs, and metabolic products. Pharmaceutical Human Albumin solutions, typically available in concentrations such as 5% and 25%, are derived from pooled human plasma and are used to restore circulating blood volume in patients with shock, trauma, surgery, or burns. They are also indicated in conditions such as hypoalbuminemia, acute liver failure, and nephrotic syndrome where endogenous albumin is reduced. Human Albumin is considered safe and effective for rapid plasma expansion, with well-established use in intensive care and emergency medicine.
Background and Date of Approval
Albumin has been used in clinical practice since the 1940s as one of the first plasma expanders. Its development was driven by the need to manage shock and severe blood loss during World War II. Since then, regulatory agencies including the FDA, EMA, and DCGI have approved Human Albumin for fluid resuscitation, burns, and hypoalbuminemia. It is manufactured under strict viral inactivation and purification processes to ensure safety. Clinical studies have confirmed its efficacy in restoring intravascular volume and improving hemodynamic stability. Although synthetic colloids such as hydroxyethyl starch have been developed, Human Albumin remains a preferred option due to its physiological compatibility and safety record.
Uses
Human Albumin is indicated for hypovolemia due to trauma, surgery, or sepsis when crystalloids alone are insufficient. It is used in burns, where fluid shifts deplete plasma volume, and in hypoalbuminemia secondary to liver cirrhosis, nephrotic syndrome, or malnutrition. In acute liver failure, it supports fluid balance and prevents complications like cerebral edema. Albumin is also used in cardiopulmonary bypass surgery, therapeutic plasma exchange, and as supportive therapy in patients with severe sepsis. Off-label, it may be used in specific oncological or critical care protocols where oncotic support is needed.
Administration
Human Albumin is administered intravenously. The dose depends on patient condition, body weight, and desired plasma volume expansion. For hypovolemia, an initial dose of 25 g of 25% solution or 250–500 ml of 5% solution is typical, repeated as needed while monitoring hemodynamic parameters. In burns and hypoalbuminemia, dosing is adjusted according to albumin levels and fluid balance. Infusions should be given slowly, and rapid administration must be avoided to prevent cardiovascular overload. Monitoring includes blood pressure, urine output, electrolytes, and serum albumin levels.
Side Effects
Human Albumin is generally well tolerated, but mild side effects can include flushing, fever, chills, nausea, and urticaria. These reactions are usually infusion-related and transient.
Warnings
Serious risks include circulatory overload, pulmonary edema, and hypersensitivity reactions such as anaphylaxis. In rare cases, rapid infusion may lead to cardiac failure, particularly in patients with renal or heart disease. Since Albumin is derived from human plasma, there is a theoretical risk of viral transmission, although modern purification and viral inactivation procedures minimize this risk.
Precautions
Caution is required in patients with severe anemia, congestive heart failure, renal impairment, or uncontrolled hypertension. Human Albumin should not be diluted with sterile water alone due to risk of hemolysis. Concomitant use with diuretics, antihypertensives, or vasopressors requires careful monitoring. Electrolyte balance should be maintained, and hypovolemia corrected gradually.
Expert Tips
Always assess volume status and hemodynamic parameters before prescribing. Use the lowest effective dose for the shortest duration needed. Counsel patients and caregivers on monitoring signs of fluid overload, such as shortness of breath or swelling. Ensure infusion is carried out in a setting with resuscitation facilities. Pharmacists should verify lot numbers and storage conditions, as Albumin products require controlled temperatures and cannot be frozen.