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.
Published Studies Related to Buminate 5% (Albumin)
Glycated albumin predicts the effect of dual and single antiplatelet therapy on
recurrent stroke. 
recurrence of stroke in patients on either dual or single antiplatelet therapy... CONCLUSIONS: GA could be a potential biomarker to predict the effects of dual and
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.
Clinical Trials Related to Buminate 5% (Albumin)
Treatment of Subarachnoid Hemorrhage With Human Albumin [Terminated]
The purpose of this study is to evaluate the tolerability and safety of 25 percent human
albumin therapy in patients with subarachnoid hemorrhage.
Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid [Completed]
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%.
Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers [Completed]
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of
Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese
Treatment of Subarachnoid Hemorrhage With Human Albumin [Terminated]
The proposed study was set up to evaluate the tolerability and safety of 25% human albumin
(HA) therapy in patients with subarachnoid hemorrhage (SAH). It is estimated that 37,500
people in the USA have SAH every year. SAH is associated with a 51% mortality rate and one
third of survivors are left functionally dependent. Cerebral vasospasm (CV) has been
identified as the most important reason for neurological deterioration. CV may be due to
multiple molecular mechanisms. The use of a neuroprotective agent with various actions,
likes HA, would be important for prevention of CV and improved clinical outcome in patients
with SAH. The proposed open-label, dose-escalation study will have important public health
implications by providing necessary information for a definitive phase III clinical trial
regarding the efficacy of treatment with HA in patients with SAH. The study was to enroll a
maximum of 80 patients with SAH who meet the eligibility criteria. Four dosages of HA
(0. 625, 1. 25, 1. 875, and 2. 5 g/kg) administered daily for seven days will be evaluated. The
lowest dosage was to be evaluated in the first group of 20 subjects. A specific safety
threshold was defined based on data from previous studies. The Data and Safety Monitoring
Board approved or disapproved advancing to the next higher HA dosage based on the evaluation
of the rate of congestive heart failure (CHF). The study assessed three outcomes: safety and
tolerability of the HA dosages and the functional outcome. The primary tolerability outcome
was defined as the subject's ability to receive the full allocated dose of HA without
incurring frank CHF that requires termination of treatment. Secondary safety outcomes were
serious adverse events (including neurological and medical complications, and anaphylactic
reactions). Neurological complications comprise incidence of CV, rebleeding, hydrocephalus,
and seizures after treatment. The three-month functional outcome determined, by Glasgow
Outcome Scale, Barthel Index, modified Rankin Scale, NIH Stroke Scale and Stroke Impact
Scale was measured to obtain a preliminary estimate of the treatment effect of HA. The
timeline of the study is three years.
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: 2015-08-10