AlbuRx® 25, Albumin (Human) 25% solution is a sterile aqueous solution for intravenous administration containing the albumin component of human blood. This product is prepared from the plasma of US donors. The product has been produced by alcohol fractionation and has been heated for 10 hours at 60°C for inactivation of infectious agents. The results of virus validation studies have shown that the manufacturing process, particularly alcohol fractionation, eliminates enveloped and non-enveloped viruses. Additionally, heat treatment at 60°C for a period of 10 hours efficiently inactivates viruses. The solution contains 130-160 milliequivalents of sodium per liter (mEq/L) and the potassium content is not over 2 mEq/L. The aluminum content does not exceed 200 µg/L. The solution is stabilized with 0.08 millimole of sodium acetyltryptophanate plus 0.08 millimole of sodium caprylate per gram of albumin. The solution contains no preservative.
3.1 General Principles17
3.1.1 Volume Deficit
Since the oncotic pressure of AlbuRx® 25, Albumin (Human) 25% solution is about four times higher than that of normal human serum, it will expand the plasma volume if interstitial water is available for an inflow through the capillary walls. However, many patients suffering from an acute volume deficit also have some degree of interstitial dehydration. In the absence of hyperhydration, the treatment of an acute volume deficit with AlbuRx® 25 should therefore include isotonic electrolyte solutions with an albumin:electrolyte ratio of 1:3 or 1:4. By contrast, chronic volume deficits have usually been at least partially compensated for by the renal retention of sodium and water with some degree of tissue edema, and in these circumstances a trial with AlbuRx® 25 only is indicated. In any case, an anemia of clinically relevant magnitude requires specific treatment, and the metabolic needs of the patient with respect to fluid and electrolytes must be cared for.
3.1.2 Oncotic Deficit
The common causes of hypoproteinemia are protein-calorie malnutrition, defective absorption in gastro-intestinal disorders, faulty albumin synthesis in chronic hepatic failure, increased protein catabolism postoperatively or with sepsis, and abnormal renal losses of albumin with chronic kidney disease. In all these settings, the circulating albumin mass is initially maintained by a gradual transfer of extravascular albumin to the circulation, and hypoproteinemia ensues only when this compensatory potential has been exhausted. This implies that manifest hypoproteinemia is usually accompanied by a hidden extravascular albumin deficit of equal magnitude as the measurable intravascular deficit, which must be allowed for if AlbuRx® 25, Albumin (Human) 25% solution is infused because of the capillary permeability of that protein.
The primary sequel of the oncotic deficit resulting from hypoproteinemia is a loss of plasma and a gain of interstitial volume with increased lymphatic flow. As a secondary response, the kidney retains sodium and water which distribute themselves on both sides of the capillary walls and the plasma volume may be returned almost to normal when the interstitial hydrostatic pressure increases sufficiently to compensate for the decrease of the serum oncotic pressure. This chain of events is accelerated by the infusion of crystalloid fluids. The plasma volume is maintained at the price of interstitial edema.2
There is some evidence that a serum oncotic pressure near 20 mmHg – equaling a total serum protein (TSP) concentration of 5.2 g/100 mL – represents a threshold, below which the risk of complications increases.17 The target organs of hypoproteinemia include the skin, the lungs, and the intestine.10 Cutaneous edema lowers the oxygen tension of wounds and may thus impair the healing process.5 An oncotic deficit favors the development of interstitial pulmonary edema4 and the intestinal accumulation of fluids, which may progress to a paralytic ileus.9
Relief of the basic pathology is the definitive mode of therapy for the restoration of the plasma protein content, but this process takes time to become effective, and the rapid correction of a critical oncotic deficit by the administration of AlbuRx® 25, Albumin (Human) 25% solution – possibly in conjunction with a diuretic – may therefore be indicated, particularly in high-risk patients who have undergone abdominal, cardio-vascular, thoracic, or urologic surgery or who have acute bacteremia. In notably catabolic patients, attempts to raise the TSP level above 6 g/100 mL usually prove futile, even with massive doses of Albumin (Human).17
It is emphasized that whereas AlbuRx® 25, Albumin (Human) 25% solution may be necessary to prevent or treat the aforementioned acute complications of hypoproteinemia, it is not indicated for treatment of the chronic condition itself.
3.2 Specific Indications17
3.2.1 Acute circumstances in which AlbuRx® 25, Albumin (Human) 25% solution use is usually appropriate
Though electrolyte solutions such as Ringer's lactate and colloid-containing plasma substitutes may be used as an emergency treatment of shock, AlbuRx® 25, Albumin (Human) 25% solution used according to the aforementioned principles has a much longer intravascular half-life and may therefore be preferable. In addition, anemia of clinically relevant magnitude requires specific therapy with red cells.
Immediate therapy during the first 24 hours is directed at the administration of large volumes of crystalloid solutions and lesser amounts of AlbuRx® 25, Albumin (Human) 25% solution to maintain an adequate plasma volume and protein (colloid) content. For continuation of therapy beyond 24 hours, larger amounts of AlbuRx® 25 and lesser amounts of crystalloid are generally used.17 An optimum regimen for the use of Albumin (Human), electrolytes, and fluid in the early treatment of burns has, however, not yet been established.
With restoration of normal capillary function, a close relationship exists once again between infused Albumin (Human) and resultant increase in plasma oncotic pressure. A goal should be sought of maintaining a plasma albumin concentration of about 2.5 ±0.5 g/100 mL or a plasma oncotic pressure of 20 mmHg (equivalent to a TSP concentration of 5.2 g/100 mL).17 In the presence of extensive granulating wounds, a daily loss of up to 30 g of albumin may continue into the late post-burn period.1 Protein-rich oral feedings, or adequate parenteral nutrition should be included in the overall regimen to the fullest possible extent, though such treatment does not permit the rapid correction of an oncotic deficit.
3.2.2 Acute circumstances in which AlbuRx® 25, Albumin (Human) 25% solution use may be appropriate
Adult Respiratory Distress Syndrome
Several factors are usually involved in the development of the state now commonly called the adult respiratory distress syndrome, one of these being a hypoproteinemic fluid overload. If present, this may be corrected by the use of AlbuRx® 25, Albumin (Human) 25% solution and a diuretic.14,17
An adequate blood volume during cardiopulmonary bypass can be maintained with crystalloids as the only pump priming fluid, but only at the price of interstitial edema. A commonly employed program is an AlbuRx® 25, Albumin (Human) 25% solution and crystalloid pump prime adjusted so as to achieve a hematocrit of 20% and a plasma albumin level of 2.5 g/100 mL in the patient, but the level to which either may be lowered safely has not yet been defined.17
Pre- and postoperative Hypoproteinemia
Patients undergoing major surgery may lose more than half of their circulating albumin mass6,9,15, and complications attributable to an oncotic deficit may occur in such cases, as well as in septic and intensive care patients. Oncotic therapy with AlbuRx® 25, Albumin (Human) 25% solution may therefore be indicated in such patients, according to the principles outlined in 3.1.2. Temporary redistribution of protein is usually not an indication for Albumin (Human).
Third Space Problems of Infectious Origin
The sequestration of protein-rich fluid during acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis may be of sufficient magnitude to require the treatment of a volume or an oncotic deficit with AlbuRx® 25, Albumin (Human) 25% solution3, although this occurrence is relatively rare.
Acute Liver Failure
In acute liver failure, AlbuRx® 25, Albumin (Human) 25% solution may serve the triple purpose of stabilizing the circulation, correcting an oncotic deficit and binding excessive serum bilirubin. The therapeutic approach is guided by the individual circumstances.17
Patients with acute nephrosis may prove refractory to cyclophosphamide or steroid therapy and their edema may even be aggravated initially by steroids. In such cases, a response may be elicited by combining 100 mL of 20–25% Albumin (Human) solution with an appropriate diuretic. This combination should be repeated daily for about one week, after which the patient may react satisfactorily to drug therapy.17
The use of AlbuRx® 25, Albumin (Human) 25% solution for blood volume support may be indicated if circulatory instability follows the withdrawal of ascitic fluid.
Red Cell Resuspension Media
As a rule, the use of Albumin (Human) for resuspending red cells can be dispensed with. However, in exceptional circumstances such as certain types of exchange transfusions and the use of very large volumes of erythrocyte concentrates and frozen or washed red cells, the addition of AlbuRx® 25, Albumin (Human) 25% solution to the resuspension medium may be indicated in order to provide sufficient volume and/or avoid excessive hypoproteinemia during the subsequent transfusion. If necessary, 20–25 g or more of Albumin (Human) per liter of red cell suspension should be added as a concentrated solution to the isotonic, electrolyte suspension of erythrocytes immediately before transfusion, the individual dosage depending on the TSP level of the recipient.
Patients undergoing long-term hemodialysis may need AlbuRx® 25, Albumin (Human) 25% solution for the treatment of a volume or an oncotic deficit. As a rule, the initial dose should not exceed 100 mL of a 20–25% solution, and the patients should be carefully observed for signs of a circulatory overload, to which they are particularly sensitive.
Hemolytic Disease of the Newborn
AlbuRx® 25, Albumin (Human) 25% solution may be indicated in order to bind and thus detoxify free serum bilirubin in severely hemolytic infants pending an exchange transfusion.
3.2.3 Circumstances in which AlbuRx® 25, Albumin (Human) 25% solution use is not justified
For the reasons set forth in sections 2. and 3.1, there is no valid reason for the use of AlbuRx® 25, Albumin (Human) 25% solution as an intravenous nutrient or for treating the stabilized hypoproteinemia accompanying chronic cirrhosis, chronic nephrosis, protein-losing enteropathy, malabsorption and pancreatic insufficiency.
If, however, a patient in this category has to cope with a superimposed acute stress, e.g. anesthesia, surgery or major infections, the patient's hemodynamic state, oncotic deficit and fluid balance should be carefully assessed and the appropriate steps taken as indicated by the individual circumstances.
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5th Annual Clinical Affairs and Regulatory Approvals for Diagnostics Conference, October 27-29, Arlington, Virginia
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Published Studies Related to Alburx (Albumin Human)
Associations of albuminuria in patients with chronic heart failure: findings in the ALiskiren Observation of heart Failure Treatment study. [2011.07]
CONCLUSIONS: Increased UACR is common in patients with heart failure, including non-diabetics. Urinary albumin creatinine ratio is independently associated with HbA1c and NT-proBNP, even in non-diabetic patients.
Long-term effects of fosinopril and pravastatin on cardiovascular events in subjects with microalbuminuria:Ten years of follow-up of Prevention of Renal and Vascular End-stage Disease Intervention Trial (PREVEND IT). [2011.06]
BACKGROUND: The PREVEND IT investigated whether treatment targeted at lowering urinary albumin excretion (UAE) would reduce adverse cardiovascular events. We obtained extended follow-up data to approximately 10 years to investigate the long-term effects of fosinopril 20 mg and pravastatin 40 mg on cardiovascular outcomes in subjects with UAE >15 mg per 24 hours... CONCLUSIONS: Elevated UAE is associated with increased cardiovascular mortality and morbidity after 9.5 years of follow-up, with a doubling of the risk if the UAE is >50 mg per 24 hours. In this group, the benefits of 4-year treatment with fosinopril were sustained during posttrial follow-up for cardiovascular mortality and morbidity. We propose that UAE be used to estimate risk in the general population and that large clinical trials be designed to confirm the hypothesis that angiotensin-converting enzyme-inhibitor treatment may be beneficial in patients with mildly elevated UAE despite the absence of other comorbidities. Copyright (c) 2011 Mosby, Inc. All rights reserved.
The Albumin in Acute Stroke Part 1 Trial: an exploratory efficacy analysis. [2011.06]
BACKGROUND AND PURPOSE: The Albumin in Acute Stroke (ALIAS) Part 2 Trial is directly testing whether 2 g/kg of 25% human albumin (ALB) administered intravenously within 5 hours of ischemic stroke onset results in improved clinical outcome. Recruitment into Part 1 of the ALIAS Trial was halted for safety reasons. ALIAS Part 2 is a new, reformulated trial with more-stringent exclusion criteria. Our aim was to explore the efficacy of ALB in the ALIAS Part 1 data and to assess the statistical assumptions underlying the ALIAS Part 2 Trial... CONCLUSIONS: Preliminary results from the ALIAS Part 1 suggest a trend toward a favorable primary outcome in subjects treated with ALB and support the validity of the statistical assumptions that underlie the ALIAS Part 2 Trial. The ALIAS Part 2 Trial will confirm or refute these results. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov/ALIAS. Unique identifier: NCT00235495.
Co-administration of albumin-furosemide in patients with the nephrotic syndrome. [2011.05]
Generalized edema is one of the most important complications in patients with nephrotic syndrome... Co-administration of albumin and furosemide increased the urine volume and sodium level, which is due to increase in the GFR as well as the diuretic effects of furosemide.
Long-term effects of Irbesartan treatment and smoking on nucleic acid oxidation in patients with type 2 diabetes and microalbuminuria: an Irbesartan in patients with type 2 diabetes and Microalbuminuria (IRMA 2) substudy. [2011.05]
CONCLUSIONS: Irbesartan treatment was not significantly more effective than placebo in reducing nucleic acid oxidation. The results indicate that DNA oxidation in diabetes patients is reduced by various components in the treatment of diabetes where glycemic control seems to be important and addition of angiotensin II receptor antagonists does not lead to any substantial additional reduction. Furthermore, the reductions in DNA oxidation and albumin excretion seem to be counteracted by smoking.
Clinical Trials Related to Alburx (Albumin Human)
Study to Evaluate the Safety of Kedbumin 25% Versus Normal Saline in the Treatment of Post-Surgical Hypovolemia in Pediatric Patients [Not yet recruiting]
This is a randomized, controlled, open-label clinical trial to be conducted at approximately
12 surgical and pediatric intensive care units (SICU/NICU/PICU) in the US, over a period of
22 months, with 6 months for trial set-up, 12 months of simultaneous subject enrollment and
30 days of treatment/follow-up period, and 3 months for study close-out.
The study population will consist of at least 60 male and female pediatric subjects between
0 days and 12 years of age, undergoing cardiac, abdominal, orthopedic or transplant surgery
with an approximately equal number of subjects (n=10 to 25) in three of the four age groups:
(29 days to 23 months), (2 to 5 years 11 months) and (6 years to 12 years) cohorts.
Regarding the youngest age group of 0 to 28 days, the minimum number of patients to be
enrolled in the study will not be predefined as very a small number of elective surgical
procedures is expected in this population.
Safety concerns and eventual safety signals, as well as recruitment rate, will be monitored
annually (starting from the enrollment of the 60th subject) by an independent Safety
Monitoring Board (SMB), which will be appointed prior to study initiation and submitted to
the FDA. The responsibilities of the SMB will be defined in ad hoc document, in which the
threshold for acceptable safety will also be set.
During the conduct of the study on the first 60 patients, if there is any safety signal
linked to the primary safety endpoint (i. e. pulmonary fluid overload) or imbalance in the
incidence of AEs between the treatment and control groups or based on relevant literature,
as judged by the SMB, the enrolment will be increased to 100 patients using the same age
stratification approach defined above (n=20 to 30 in each age group).
Potential subjects will be pre-screened and informed consent/assent will be obtained from
the subject and/or subject's parents or guardians prior to surgery. Post-surgery, the
subject will be admitted to the Surgical, Neonatal, or Pediatric Intensive Care Unit
(SICU/NICU/PICU) for postoperative recovery and care management. Subjects who show signs of
hypovolemia as judged by the Principal Investigator (PI) will be screened to determine their
eligibility to participate in this trial. Subjects will then be randomized to receive
treatment with Kedbumin 25% or the comparator, normal saline (sodium chloride 0. 9%).
There is no specific post-treatment regimen for this protocol, as all subjects will receive
the standard post-operative care based on their clinical status and response to treatment at
the discretion of the Investigator.
Vital signs and fluid management/replacement therapy recorded in the medical chart and
results of standard complete blood count (CBC), biochemistry, and hematology and coagulation
lab panels will be reviewed and recorded by research staff at specified time points,
according to the hospital standard of care. Additionally, research staff will review and
record daily lactate, urine albumin, blood urea nitrogen (BUN), creatinine, and non-invasive
measurements at the following time points: Baseline, 6hr, 12hr, 24hr, 36hr, 48hr, and 72hr
post-onset of hypovolemia), until hemodynamic stability is achieved. Hemodynamic stability
will be evaluated based on site-specific age-defined reference ranges for heart rate, blood
pressure, urine output, and cardiac index in children.
The volume, rate and frequency of the Investigational Medicinal Product (IMP, either
Kedbumin 25% or normal saline) administered will be recorded in addition to the type,
timing, and amount of all other fluids administered. The time to hemodynamic stability,
duration of stability once attained, and any relapse requiring additional treatment or use
of secondary resuscitation strategies will be recorded. Subjects who demonstrate hemodynamic
stability within 3 days after treatment initiation and then relapse into hemodynamic
instability as a result of surgical complications or infection will exit from the study, but
the data be considered for the safety analysis. These subjects should continue treatment
according the clinical practice standard since the study is not intended to evaluate the
efficacy of Kedbumin 25%.
Treatment of Subarachnoid Hemorrhage With Human Albumin [Recruiting]
The purpose of this study is to evaluate the tolerability and safety of 25 percent human
albumin therapy in patients with subarachnoid hemorrhage.
Human Albumin for the Treatment of Ascites in Patients With Hepatic Cirrhosis [Recruiting]
Ascites is the most frequent complication of liver cirrhosis and carries a significant
worsening of the prognosis. Approximately 10% of patients per year develop refractory
ascites because of either the lack of response to medical treatment or the onset of
diuretic-induced complications that preclude the use of an effective dosage. Refractory
ascites is associated with an increased incidence of severe complications of cirrhosis.
Thus, the overall probability of survival of patients with refractory ascites is very poor,
being approximately 30% at 2 years. Repeated large-volume paracentesis, transjugular
intrahepatic portosystemic shunt (TIPS), and liver transplantation represent the therapeutic
alternatives for refractory ascites. As renal sodium retention and ascites formation are the
consequence of portal hypertension and effective hypovolemia, the preservation of the
central blood volume represents a major purpose in the management of patients with advanced
cirrhosis. Although albumin is responsible for about 70% of the plasma oncotic pressure, the
absence of large multicenter randomized studies together with its high cost explains why
albumin infusion is not usually included among the therapeutic options for
The objective of the present study is to define the effectiveness of the prolonged
administration of human albumin in the treatment of liver cirrhosis with ascitic
decompensation. This goal will be reached by performing a multicenter, prospective,
randomized clinical trial comparing the efficacy of chronic albumin administration on top of
standard medical treatment versus standard medical treatment alone in patients with
cirrhosis and ascites.
The study will be conducted in 44 Italian clinical centers and will enrol 440 in- or
out-patients affected by liver cirrhosis with uncomplicated ascites who will be randomized
with a ratio of 1: 1. The duration of the study for each patient is 18 months from
randomization. The enrolment of patients will last 18 months and will be competitive between
centers. Treatment will be interrupted if one of the following condition occur: orthotopic
liver transplantation, TIPS, need of 3 paracentesis/month (indication to TIPS), patient
refusal to continue, and medical judgement.
An ancillary optional study will be performed in a subset of patients to analyze the
non-oncotic properties of albumin.
Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of plasma exchange with 5%
albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in
patients with mild-moderate Alzheimer's disease.
Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine [Recruiting]
The purpose of this study is to determine if a new medium with no human serum albumine added
is as good as the media conventionally used for IVF/ICSI.
Page last updated: 2014-07-24