BUMINATE 5% SUMMARY
BUMINATE 5%, Albumin (Human), 5% Solution, is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin and was prepared from human venous plasma using the Cohn cold ethanol fractionation process. Source material for fractionation may be obtained from another U.S. licensed manufacturer. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and has been stabilized with sodium acetyltryptophanate and sodium caprylate. The sodium content is 145 ± 15 mEq/L. The solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. BUMINATE 5%, Albumin (Human), 5% Solution, is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.
BUMINATE 5% Solution is indicated for the following:
Hypovolemia is a possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Its effectiveness in reversing hypovolemia depends largely upon its colloid osmotic pressure. Although crystalloid solutions and colloid-containing plasma substitutes can be used in emergency treatment of shock, Albumin (Human) has a longer intravascular half-life than crystalloid solutions.9
When the hypovolemia is long-standing and hypoalbuminemia exists accompanied by adequate hydration or edema, treatment with BUMINATE 25%, Albumin (Human), 25% Solution, is preferable.4,6
When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible.
Hypoalbuminemia is another possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Hypoalbuminemia can result from one or more of the following:5
Inadequate production (malnutrition, burns, major injury, infections, etc.)
Excessive catabolism (burns, major injury, pancreatitis, etc.)
Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
Redistribution within the body (major surgery, various inflammatory conditions, etc.)
When albumin deficit is the result of excessive protein loss, the effect of administration of albumin will be temporary unless the underlying disorder is reversed. In most cases, increased nutritional replacement of amino acids and/or protein with concurrent treatment of the underlying disorder will restore normal plasma albumin levels more effectively than administration of albumin solutions. Occasionally hypoalbuminemia accompanying severe injuries, infections or severe pancreatitis cannot be quickly reversed and nutritional supplements may fail to restore adequate plasma albumin levels. In these cases, BUMINATE 5%, Albumin (Human), 5% Solution, may be useful.
In conjunction with appropriate crystalloid therapy, BUMINATE 5%, Albumin (Human), 5% Solution, may be useful for treatment of protein deficits after the initial 24-hour period following extensive burns.4
- Miscellaneous Indications
BUMINATE 5%, Albumin (Human), 5% Solution, may be indicated prior to or during cardiopulmonary bypass surgery, though the data do not indicate a clear-cut advantage over crystalloid solutions.4,6,10
There is no valid reason for use of albumin as an intravenous nutrient.
Media Articles Related to Buminate 5% (Albumin)
New implications for controversial kwashiorkor treatment uncovered
Source: Blood / Hematology News From Medical News Today [2015.05.20]
For many years, the essential cause of oedema in kwashiorkor was considered to be low oncotic pressure owing to low plasma albumin concentration.
Diabetic Nephropathy - Early intervention is the key
Source: The Doctors Lounge - Nephrology
Dr. Riham explains how annual screening for microalbuminuria in diabetic patients will allow early identification of nephropathy.
Published Studies Related to Buminate 5% (Albumin)
Effects of combined lipoic acid and pyridoxine on albuminuria, advanced glycation
end-products, and blood pressure in diabetic nephropathy. 
This study was designed to investigate the effects of combined administration of
lipoic acid and pyridoxine on albuminuria, oxidative stress, blood pressure,
serum advanced glycation end-products, nitric oxide (NO), and endothelin-1 in
patients with diabetic nephropathy.
High-dose albumin treatment for acute ischaemic stroke (ALIAS) Part 2: a
randomised, double-blind, phase 3, placebo-controlled trial. 
proportion of patients with a favourable outcome... INTERPRETATION: Our findings show no clinical benefit of 25% albumin in patients
Albumin resuscitation for traumatic brain injury: is intracranial hypertension
the cause of increased mortality? 
Mortality is higher in patients with traumatic brain injury (TBI) resuscitated
with albumin compared with saline, but the mechanism for increased mortality is
Sulodexide for kidney protection in type 2 diabetes patients with microalbuminuria: a randomized controlled trial. [2011.11]
BACKGROUND: Sulodexide, a heterogenous group of sulfated glycosaminoglycans, includes low-molecular-weight heparin (~80% +/- 8%), high-molecular-weight heparin (~5% +/- 3%), and dermatan (~20% +/- 8%), with a mean molecular weight of ~9 kDa. The drug is absorbed orally and has no anticoagulant effect in the doses used. Small preliminary studies consistently showed sulodexide to be associated with decreased albuminuria in patients with diabetes... CONCLUSION: Sulodexide failed to decrease urine albumin excretion in patients with type 2 diabetic nephropathy and microalbuminuria. Copyright (c) 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.
Pioglitazone delays proximal tubule dysfunction and improves cerebral vessel endothelial dysfunction in normoalbuminuric people with type 2 diabetes mellitus. [2011.10]
AIM: The renal and cerebral protective effects of pioglitazone were assessed in normoalbuminuric patients with type 2 diabetes mellitus (DM)... CONCLUSION: Proximal tubule (PT) dysfunction precedes albuminuria and is dissociated from endothelial dysfunction in patients with type 2 DM. Pioglitazone delays PT dysfunction and improves cerebral vessels endothelial dysfunction in normoalbuminuric patients with type 2 DM. Copyright (c) 2011 Elsevier Ireland Ltd. All rights reserved.
Clinical Trials Related to Buminate 5% (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.
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.
The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke [Not yet recruiting]
In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the
patients occurred within 12 hours of acute ischemic stroke.
Reports of Suspected Buminate 5% (Albumin) Side Effects
Hepatitis C (2),
Hepatitis C Antibody Positive (1),
Body Temperature Increased (1),
Cardiac Failure Congestive (1),
Post Procedural Infection (1),
Alanine Aminotransferase Increased (1),
Creutzfeldt-Jakob Disease (1),
Aspartate Aminotransferase Increased (1), more >>
Page last updated: 2015-05-20