Albumin Human

Class: Blood Derivatives
ATC Class: B05AA01
VA Class: BL500
CAS Number: 9048-46-8
Brands: Albuminar, AlbuRx, Albutein, Buminate, Flexbumin, Plasbumin

Introduction

A protein colloid; a sterile solution of serum albumin prepared by fractionating pooled plasma from healthy human donors.^{133 139 204 205 206 207 208 210 211 212 213 214 215 254 255 256}

Uses for Albumin Human

Hypovolemia

Used for plasma volume expansion and maintenance of cardiac output (fluid resuscitation) in the emergency treatment of hypovolemia (with or without shock) when urgent restoration of blood volume is indicated.^{187 204 205 206 207 208 210 211 212 213 214 215 218 220 221 226 227 254 255 256 295 297 300 301 303 304}

Goal of fluid resuscitation is to restore intravascular volume and preserve organ perfusion while minimizing complications of fluid overload (e.g., pulmonary edema).^{187 225}

Albumin human, a protein colloid, is one of several options that can be used to restore effective circulating volume; other options include nonprotein colloids (e.g., hetastarch, dextran) and large volume crystalloids (e.g., lactated Ringer's, various sodium chloride-containing solutions).^{148 187 219 222 225 226 227 228 304 308}

Beneficial effect of albumin human for fluid resuscitation is thought to result principally from its contribution to colloid osmotic pressure (i.e., oncotic pressure).^{148 210 211}

Albumin human should not be considered a substitute for blood or blood components when oxygen-carrying capacity is reduced and/or when replenishment of clotting factors or platelets is necessary.^{134 170 187} Transfusion with whole blood or packed RBCs is required in patients with active hemorrhage and/or substantial anemia.^{204 205 207 208 210 211 214 215}

Controversy exists regarding optimum choice of fluid (i.e., crystalloids, albumin human, nonprotein colloids) for fluid resuscitation.^{148 187 219 220 222 225 226 227 228 261 299 303 304 308} Protocols used, including type of replacement fluid, vary widely among health-care facilities^{148 187 219 220 222 225 226 227 228 261 303 304 308} and may depend on geographic area (e.g., country).³⁰⁴

Theoretical advantages of colloids include greater retention in the intravascular space, more effective and rapid plasma volume expansion, and reduced risk of pulmonary edema.^{187 211 214 220 225 226 227 228} However, colloids generally have not been shown to be more effective than crystalloids, and costs associated with colloids are substantially higher than those associated with crystalloids.^{148 187 219 220 222 225 226 228}

Based on current evidence, albumin human appears to offer no survival advantage over crystalloids for fluid resuscitation; possibility of a modest benefit or harm cannot be excluded.^{187 218 219 222 225} Additional studies needed to determine role of albumin human in selected patient populations.^{218 219 222 224 225}

Hemorrhagic Shock

Used for fluid resuscitation in patients with hemorrhagic shock.^{187 301}

Guidelines on use of albumin, nonprotein colloids, and crystalloids issued in 2000 by the US University Health System Consortium (UHC) state that crystalloids are preferred for initial fluid resuscitation in adults with hemorrhagic shock.¹⁸⁷ Nonprotein colloids may be considered when crystalloids (4 L) fail to produce an adequate response within 2 hours; albumin human 5% solution may be considered if nonprotein colloids are contraindicated.¹⁸⁷

Initiate transfusion with whole blood or packed RBCs as soon as possible when there is active hemorrhage and/or substantial anemia.^{204 205 207 208 210 211 214 215 254 255 256}

Nonhemorrhagic (Maldistributive) Shock

Has been used for fluid resuscitation in patients with nonhemorrhagic (maldistributive) shock, including septic shock.^{187 250 261 295 297 299 300}

UHC guidelines state that crystalloids should be considered first-line therapy in adults with nonhemorrhagic (maldistributive) shock and that nonprotein colloids and albumin human should be used with caution in those with systemic sepsis.¹⁸⁷ In the presence of capillary leak with pulmonary and/or severe peripheral edema, use of up to 4 L of crystalloid solution is appropriate before using colloids.¹⁸⁷ If albumin human is used for acute management of nonhemorrhagic shock, consider possibility of a potentially detrimental effect on edema in patients with increased capillary permeability or capillary leak.^{152 168 187}

Other experts state that either crystalloids or colloids can be used for fluid resuscitation in patients with septic shock.^{250 251 261 295 297 300} Although there is some evidence that adult or pediatric patients with severe infection and shock who receive albumin human have lower mortality compared with those who receive crystalloids,^{222 261 297 299 300} prospective, randomized studies are needed to clearly identify which type of fluid is superior for fluid resuscitation in patients with septic shock.^{250 251 261 297 298 299 300}

Thermal Injury

Has been used for fluid resuscitation in burn patients.^{187 218 302 305 306 307 309}

Fluid resuscitation is an essential component of burn therapy,^{187 306} but optimum regimen of crystalloids, colloids, electrolytes, and fluid not clearly established.^{204 205 207 208 211 213 214 215 218 302 305 306 307 309}

Crystalloids generally recommended for initial fluid resuscitation during first 24 hours following thermal injury.^{187 204 205 207 211 213 214 309} Beyond 24 hours, colloids may be used in conjunction with crystalloids to prevent hemoconcentration, combat electrolyte imbalances, and counteract protein deficits.^{204 205 207 208 210 211 213 214 215 309} To avoid complications of over-resuscitation (“fluid creep”), such as abdominal compartment syndrome and ARDS, use minimal amount of fluid necessary to maintain adequate organ perfusion.^{305 306 307 309}

UHC guidelines recommend crystalloids for initial fluid resuscitation in adults with thermal injury, but state that nonprotein colloids may be added if burns extend over >30% of body surface area and if >4 L of crystalloid has been administered 18–26 hours following initial injury; albumin human may be considered if nonprotein colloids are contraindicated.¹⁸⁷

Guidelines issued by the American Burn Association state that the addition of colloids to burn resuscitation protocols may be beneficial in terms of decreasing total fluid volume requirements, but randomized, controlled trials are needed to clearly establish other benefits.³⁰⁷

In pediatric burn patients, albumin human does not appear to decrease morbidity and mortality¹⁸⁷ and, depending on the preparation used, may result in aluminum accumulation in infants.^{140 143 144 187} (See Aluminum Content under Cautions.)

Nephrosis and Nephrotic Syndrome

Used as an adjunct to diuretic therapy to treat edema in patients with acute nephrosis refractory to cyclophosphamide and steroid therapy.^{187 204 205 206 208 214 215 245 255 256}

Cardinal features of nephrotic syndrome include albuminuria, hypoalbuminemia, and edema.¹⁸⁷ Decreased hepatic production and increased renal catabolism are responsible for hypoalbuminemia and renal sodium retention is responsible for edema.¹⁸⁷

Principal goal of therapy is treatment of the underlying cause.¹⁸⁷ Diuretic therapy is treatment of choice for symptomatic management.¹⁸⁷

UHC guidelines recommend short-term adjunctive use of albumin human with diuretics in adults with nephrotic syndrome who have acute, severe peripheral and/or pulmonary edema unresponsive to diuretics alone;¹⁸⁷ consider possibility of potentially detrimental effect on edema.^{152 168 187}

Albumin human has no role in management of chronic nephrosis; parenteral albumin is rapidly excreted renally with no relief of chronic edema and no effect on the underlying renal lesion.^{134 204 205 213 214}

Hemodialysis

Has been used as an adjunct to hemodialysis in long-term hemodialysis patients with oncotic or volume deficits or in those experiencing shock or hypotension who cannot tolerate substantial volumes of sodium chloride solution.^{204 205 206 212 214 261 265 266}

Intradialytic hypotension, a complication of hemodialysis (especially in long-term hemodialysis patients), usually is managed by volume expansion through the use of crystalloids (e.g., 0.9% sodium chloride solutions, hypertonic sodium chloride solutions), nonprotein colloids, or albumin human.^{261 265 266}

Although some experts recommend colloids for dialysis-related hypotension and maintenance of hemodynamics in chronic dialysis patients,²⁶¹ others state that 0.9% sodium chloride solution should be considered first-line therapy for treatment of intradialytic hypotension in maintenance hemodialysis patients.²⁶⁵

UHC guidelines state that albumin human should not be used for intradialytic blood pressure support.¹⁸⁷ If hemodialysis patients experience shock symptoms, crystalloids should be used for initial fluid resuscitation; nonprotein colloids may be considered if crystalloids (4 L) fail to produce an adequate response within 2 hours; albumin human 5% solution may be used if nonprotein colloids are contraindicated.¹⁸⁷

Cirrhotic Ascites and Paracentesis

Used to prevent central volume depletion following paracentesis in adults with cirrhosis who require removal of large volumes of ascitic fluid.^{187 214 226 236 254 255 256 261 286 287 310}

Diet modification (e.g., sodium restricted to 2 g daily) combined with oral diuretic therapy is first-line therapy for cirrhosis and ascites.^{187 236 286}

If tense ascites is present in new-onset disease, an initial large-volume paracentesis may be necessary in addition to sodium restriction and oral diuretics.^{236 286} In those with refractory ascites (fluid overload unresponsive to sodium restriction and high-dose oral diuretic therapy or that recurs rapidly after paracentesis), serial therapeutic paracentesis may be indicated to control ascites.^{236 287}

A single paracentesis involving removal of ≤4–5 L of fluid usually can be performed safely without postparacentesis colloid support; when larger volumes (>5 L) are removed, use of albumin human may be considered and usually is recommended to decrease risk of postparacentesis circulatory dysfunction and maintain effective arterial blood volume.^{187 236 261 264 286 287}

Although albumin human has been used alone (without large-volume paracentesis) in patients with cirrhosis in an attempt to control or prevent recurrence of ascites,^{187 236 285 236} guidelines from the American Association for the Study of Liver Diseases (AASLD) and UHC state that such use is notrecommended.^{187 236}

UHC guidelines state that albumin human should notbe used for treatment of noncirrhotic postsinusoidal portal hypertension†.¹⁸⁷

Despite the presence of hypoalbuminemia, albumin human has no role in the management of chronic cirrhosis†.^{21 134 148 204 205 206}

Hepatorenal Syndrome

Has been used in conjunction with vasoconstrictors for treatment of type I hepatorenal syndrome† in patients with cirrhosis.^{226 236 243 244 264 286 287 288 289 290 291 292 293 294}

Type I hepatorenal syndrome is characterized by acute, rapidly progressing renal failure caused by intrarenal vasoconstriction and usually requires liver transplantation if not reversed.^{236 244 286 287 288 289 293 294}

Although additional study is needed, AASLD and other experts state that a regimen of albumin human used in conjunction with vasoconstrictors (e.g., terlipressin [not commercially available in the US], octreotide and midodrine, norepinephrine) should be considered in the treatment of type I hepatorenal syndrome†.^{236 264 289 294}

Data are limited regarding use of albumin human alone or in conjunction with vasoconstrictors in the management of type II hepatorenal syndrome† (characterized by moderate and slowly progressive renal failure and typically associated with refractory ascites); additional study is needed to determine if albumin human has a role in this form of the disease.^{236 289 291 294}

Spontaneous Bacterial Peritonitis

Has been used for volume expansion as an adjunct to anti-infectives in the treatment of spontaneous bacterial peritonitis† in patients with cirrhosis and ascites.^{187 236 267 268 269 286 289 293}

Spontaneous bacterial peritonitis is a complication that can occur in patients with cirrhosis and ascites, develops without a contiguous source of infection (e.g., intestinal perforation, intra-abdominal abscess), requires prompt empiric anti-infective therapy, and may result in potentially fatal, progressive renal impairment and/or hepatorenal syndrome.^{236 267 286 287} Although there is some evidence that adjunctive use of albumin human for volume expansion in addition to appropriate anti-infective treatment may decrease risk of renal impairment and death,^{236 261 267 268 269 286} such use is controversial and additional study is needed.^{187 267 268 269 270 289}

AASLD recommends that albumin human be used in addition to appropriate anti-infective treatment (e.g., cefotaxime) in patients who have ascitic fluid polymorphonuclear (PMN) counts ≥250 cells/mm³ and also have S _cr >1 mg/dL, BUN >30 mg/dL, or total bilirubin >4 mg/dL.²³⁶

Acute Liver Failure

Has been used in patients with acute liver failure.^{205 206 213 296}

May serve dual purpose of supporting plasma colloid osmotic pressure as well as binding excess plasma bilirubin in the uncommon situation of rapid loss of liver function, with or without coma.^{204 205 213}

Individualize use in patients with acute liver failure.²⁰⁶ When fluid resuscitation is indicated, some experts recommend use of colloids (e.g., albumin human) instead of crystalloids.²⁹⁶

Hepatic Resection

Has been used for postoperative fluid support in patients undergoing hepatic resection†.¹⁸⁷ Surgical liver resection results in substantial blood loss and, depending on preoperative functional status of the liver, decreased albumin production capacity.¹⁸⁷

UHC guidelines state that crystalloids are first-line therapy for maintenance of effective circulating volume following hepatic resection in adults; if crystalloids have no effect and anemia and/or coagulopathy are present, consider use of packed RBCs and fresh frozen plasma before use of albumin human.¹⁸⁷

UHC guidelines state that albumin human is appropriate to maintain effective circulation volume following major (>40%) hepatic resection in adults and also is indicated if clinically important edema develops secondary to use of crystalloids.¹⁸⁷

Hypoproteinemia

Has been used in management of severe hypoalbuminemia (with or without edema) in an attempt to restore serum albumin concentrations to within normal range.^{204 205 207 208 210 211 212 214 215 254 255 266} However, in the absence of clinically important hypovolemia, should not be used to correct temporary protein deficits resulting from redistribution of albumin.^{211 214 231}

Hypoproteinemia (hypoalbuminemia) can occur in association with various clinical conditions (e.g., surgery, sepsis, chronic liver failure, chronic renal impairment) and is a result of inadequate production, increased catabolism, redistribution, and/or excessive loss of albumin.^{204 205 206 208 210 211 214 215 231}

Principal goal of therapy is treatment of the underlying cause; albumin human may be used to provide symptomatic relief and prevent acute complications.^{204 205 206 207 208 210 211 212 214 215 226}

May relieve edema associated with hypoproteinemia by increasing colloid osmotic pressure and producing diuresis.^{207 214} However, there is potential risk of fluid overload if administered to normovolemic patients with hypoproteinemia.²³¹

Not recommended for use in severe hypoalbuminemia in the absence of hypovolemia simply to increase serum albumin concentrations to normal; identify and treat cause of the underlying hypoalbuminemia instead.^{147 152}

Should not be used for treatment of hypoproteinemia associated with chronic cirrhosis, chronic nephrosis, malabsorption, protein-losing enteropathies, pancreatic insufficiency, or malnutrition, unless a concomitant indication warrants use.^{204 205 211 213 214}

Has been used to treat neonatal hypoalbuminemia†, but data are insufficient to determine whether routine use of albumin human reduces mortality or morbidity in preterm neonates with hypoalbuminemia.²³¹

Nutritional Support

Not recommended for use as a supplemental caloric protein source in nutritional support†.^{21 148 187 204 205 206 208 210 211 213 214 215 226}

Oral, enteral, and/or parenteral nutrition with amino acids and treatment of underlying disorders generally restore plasma protein concentrations more effectively than albumin human.^{208 210 215}

Albumin human may be beneficial for severe diarrhea (>2 L daily) associated with enteral feeding intolerance† when serum albumin concentration is <2 g/dL or if diarrhea occurs despite a trial of short-peptide and elemental formulas and other causes of diarrhea have been excluded.^{134 148 177 187}

Neonatal Hyperbilirubinemia

Adjunct to exchange transfusions in the treatment of neonatal hyperbilirubinemia, including hemolytic disease of the newborn (erythroblastosis fetalis).^{187 204 205 206 208 214 215 255 256}

Because of its ability to bind unconjugated bilirubin, albumin human may decrease risk of kernicterus in infants with hyperbilirubinemia.^{187 204 205 206 208 214 215 255 256}

Has been administered prior to exchange transfusion (as a primer) or during the procedure (as a substitute for a portion of the blood).^{187 204 205 208 214 215} Because there is some evidence that administration prior to exchange transfusion is less efficient in bilirubin removal and may increase the risk of volume overload, UHC guidelines recommend administration during the procedure if albumin human is used as an adjunct to exchange transfusion.¹⁸⁷

Use caution in hypervolemic infants.^{204 205 214} (See Hypervolemia/Hemodilution under Cautions.)

Not indicated when neonatal hyperbilirubinemia is treated using phototherapy without exchange transfusions.^{134 187}

Crystalloids and nonprotein colloids do not share the bilirubin-binding properties of albumin human and should not be considered alternatives for adjunctive treatment of neonatal hyperbilirubinemia.¹⁸⁷

Ovarian Hyperstimulation

Used as a plasma expander for fluid management in women with severe ovarian hyperstimulation syndrome (OHSS).^{255 256} Albumin human 20 or 25% solutions have been recommended in the treatment of severe OHSS if 0.9% sodium chloride solutions fail to achieve or maintain hemodynamic stability and adequate urine output.^{238 255 256}

Has been investigated for prevention of severe OHSS in high-risk women undergoing ovulation induction†.^{187 232 237 238 239 240 241 242 258 259 260} Additional study needed to more fully evaluate benefits and risks for prevention of OHSS.^{187 232 260} Although there is some evidence that administration of albumin human 20 or 25% solution immediately before or after oocyte retrieval can reduce the risk of severe OHSS in high-risk women (i.e., <35 years of age, multifollicular development, high serum estradiol concentrations, nonobesity, polycystic ovary disease),^{232 237 238 239 240 241 242} other studies failed to confirm such benefits.^{258 259 260}

Acute Respiratory Distress Syndrome and Acute Lung Injury

Has been used in conjunction with a diuretic in the management of ARDS.^{148 171 177 204 205 206 208 214 215 255 256}

Use in ARDS is controversial because of the risk of aggravating interstitial fluid accumulation and other possible detrimental pulmonary effects.^{134 171 172 173 177} Although uncertainty exists regarding the precise indication in patients with ARDS,^{208 214 215 261} some manufacturers state that albumin human may have a therapeutic effect if used in conjunction with a diuretic in patients with pulmonary overload accompanied by hypoalbuminemia.^{208 214 215}

Has been used in conjunction with furosemide in the management of hypoproteinemic patients with acute lung injury† (ALI) and has resulted in improved oxygenation and hemodynamic stability in some patients.^{261 262 263 283} Some experts state that conservative fluid management or restriction is appropriate for most patients with hemodynamically stable ALI/ARDS,^{261 283 284 283} but a regimen of colloids and diuretics may be considered in those with hypo-oncotic ALI/ARDS.^{261 283}

Sequestration of Protein Rich Fluids

Has been used for volume and oncotic replacement in conditions associated with sequestration of protein rich fluid (third-spacing) (e.g., acute peritonitis, pancreatitis, mediastinitis, extensive cellulitis).^{204 205 211 213 214}

Has been used as an adjunct to anti-infectives in the treatment of spontaneous bacterial peritonitis† in patients with cirrhosis and ascites.^{187 236 267 268 269 286} (See Spontaneous Bacterial Peritonitis under Uses.)

May be useful in early treatment of shock associated with acute hemorrhagic pancreatitis or peritonitis.²¹¹

UHC guidelines state that albumin human is not recommended in the treatment of acute or chronic pancreatitis.¹⁸⁷

Cardiac Surgery

Has been used as a pump prime for preoperative dilution of blood prior to cardiopulmonary bypass procedures,^{187 204 205 206 208 210 212 213 214 281 282} usually in conjunction with a crystalloid.^{187 204 205 213 214 215 282}

UHC guidelines state that crystalloids alone are preferred for priming cardiopulmonary bypass pumps in adults, although use of nonprotein colloids in addition to crystalloids may be preferred when it is extremely important to avoid pulmonary shunting.¹⁸⁷

Has been used in cardiac surgery patients to restore fluid balance during surgery and in the postoperative period;^{187 208 210 215 281} however, there are no data establishing clear benefit over crystalloids alone.^{187 208 210 215} For postoperative volume expansion after cardiac surgery in adults, UHC guidelines state that crystalloids are preferred, followed in descending order of preference by nonprotein colloids and then albumin human.¹⁸⁷

Neurosurgery and Cerebral Injury

Has been used for hemodilution to maintain or improve cerebral perfusion in the treatment of subarachnoid hemorrhage†, acute ischemic stroke†, traumatic brain injury†, and in other neurosurgical patients†.^{174 175 176 187 261 272 273 274 275 276 277 278 279 280}

Various fluid protocols have been used in an attempt to prevent secondary ischemia after subarachnoid hemorrhage, severe ischemic stroke, or severe traumatic brain injury; improved clinical outcomes reported in some patients.^{187 272 275 276 277 278 279} However, there is no clear evidence to date from adequately controlled, randomized studies that hemodilution decreases mortality or improves functional outcome in survivors of acute ischemic stroke.^{187 274}

UHC guidelines state that crystalloids are preferred for maintenance of cerebral perfusion pressure in the treatment of cerebral vasospasm associated with subarachnoid hemorrhage, cerebral ischemia, or head trauma in adults, but albumin human 25% solution should be used if cerebral edema is a concern.¹⁸⁷ Patients with elevated hematocrits should receive crystalloids first to increase intravascular volume, creating a state of hypervolemia and hemodilution; those with hematocrits <30% should receive packed RBCs to increase intravascular volume and maintain cerebral perfusion pressure.¹⁸⁷ If volume therapy alone is inadequate to maintain cerebral perfusion pressure, vasopressor therapy may be necessary.¹⁸⁷

Liver or Kidney Transplantation

Has been used to control ascites and severe pulmonary and peripheral edema in liver transplant recipients†.¹⁸⁷ Because of excessive blood loss, volume expanders such as crystalloids, blood products, nonprotein colloids, and albumin human may be required intraoperatively during liver transplantation.¹⁸⁷

UHC guidelines state that albumin human may be used in adult liver transplant recipients when serum albumin is <2.5 g/dL, pulmonary capillary wedge pressure is <12 mm Hg, and hematocrit is >30%.¹⁸⁷

Has been used intraoperatively in conjunction with crystalloids for volume expansion in kidney transplant patients.^{148 187} However, there is no conclusive evidence from controlled, randomized studies that albumin human given during and/or after renal transplant surgery improves outcome.^{148 187}

Plasmapheresis

Used in conjunction with large-volume plasma exchange as protein volume replacement in plasmapheresis† procedures involving exchange of >20 mL of plasma/kg in one session or >20 mL/kg weekly in multiple sessions.^{148 187}

UHC guidelines state that nonprotein colloids and crystalloids may substitute for some of the albumin human in therapeutic plasmapheresis† procedures and should be considered cost-effective exchange media.¹⁸⁷

Some evidence indicates that nonprotein colloids (e.g., hetastarch 3%) are comparably effective and tolerated relative to albumin for small- or large-volume plasma exchange.^{134 178 179 180 181}

Erythrocyte Resuspension

Has been used to resuspend large volumes of previously frozen or washed RBCs prior to administration or during certain types of exchange transfusion to provide sufficient volume and/or avoid excessive hypoproteinemia during the transfusion.^{204 205 214}

Albumin Human Dosage and Administration

Administration

Administer by IV infusion.^{204 205 206 207 208 210 211 212 213 214 215 254 255 256}

Concentration administered depends on fluid and protein requirements of the patient.^{21 204 205 208 210 213 215}

Albumin human 5% solution: Generally preferred for treatment of acute blood volume deficits in the absence of adequate or excessive hydration.^{204 205 208 213 215}

Albumin human 20 or 25% solutions: May be preferred in patients with oncotic deficits or in those with long standing hypovolemia and hypoalbuminemia that exists in the presence of adequate or excessive hydration.^{204 205 208 210 215} Also