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Buminate 5% (Albumin) - 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:

  1. Hypovolemia
    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.
  2. Hypoalbuminemia
    1. General
      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
      1. Inadequate production (malnutrition, burns, major injury, infections, etc.)
      2. Excessive catabolism (burns, major injury, pancreatitis, etc.)
      3. Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
      4. 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.
    2. Burns
      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
  3. 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.

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Media Articles Related to Buminate 5% (Albumin)

Positive pooled analysis demonstrating the effect of dapagliflozin on albuminuria in hypertensive patients with type 2 diabetes
Source: Hypertension News From Medical News Today [2015.09.21]
AstraZeneca has announced findings from a new post-hoc analysis of two Phase III trials, in which dapagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, 5 and 10 mg/d demonstrated...

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.

more news >>

Published Studies Related to Buminate 5% (Albumin)

Glycated albumin predicts the effect of dual and single antiplatelet therapy on recurrent stroke. [2015]
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. [2013]
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. [2013]
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? [2013]
Mortality is higher in patients with traumatic brain injury (TBI) resuscitated with albumin compared with saline, but the mechanism for increased mortality is unknown...

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.

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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 healthy volunteers.

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.

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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)Dyspnoea (1)Alanine Aminotransferase Increased (1)Tremor (1)Creutzfeldt-Jakob Disease (1)Aspartate Aminotransferase Increased (1)more >>

Page last updated: 2015-09-21

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