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Plasbumin-25 (Albumin) - Summary

 



PLASBUMIN-25 SUMMARY

Albumin (Human) 25%, USP (Plasbumin®-25) is made from pooled human venous plasma using the Cohn cold ethanol fractionation process. Part of the fractionation may be performed by another licensed manufacturer. It is prepared in accordance with the applicable requirements established by the U.S. Food and Drug Administration.

Plasbumin-25 is hyperoncotic and on intravenous infusion will expand the plasma volume by an additional amount, three to four times the volume actually administered, by withdrawing fluid from the interstitial spaces, provided the patient is normally hydrated interstitially or there is interstitial edema.1 If the patient is dehydrated, additional crystalloids must be given,4 or alternatively, Albumin (Human) 5%, USP (Plasbumin®-5) should be used. The patient's hemodynamic response should be monitored and the usual precautions against circulatory overload observed. The total dose should not exceed the level of albumin found in the normal individual, i.e., about 2 g per kg body weight in the absence of active bleeding. Although Plasbumin-5 is to be preferred for the usual volume deficits, Plasbumin-25 with appropriate crystalloids may offer therapeutic advantages in oncotic deficits or in long-standing shock where treatment has been delayed.2

Removal of ascitic fluid from a patient with cirrhosis may cause changes in cardiovascular function and even result in hypovolemic shock. In such circumstances, the use of an albumin infusion may be required to support the blood volume.2

An optimal therapeutic regimen with respect to the administration of colloids, crystalloids, and water following extensive burns has not been established. During the first 24 hours after sustaining thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours Plasbumin-25 can be used to maintain plasma colloid osmotic pressure.

During major surgery, patients can lose over half of their circulating albumin with the attendant complications of oncotic deficit.2,4,5 A similar situation can occur in sepsis or intensive care patients. Treatment with Plasbumin-25 may be of value in such cases.2

This is characterized by deficient oxygenation caused by pulmonary interstitial edema complicating shock and postsurgical conditions. When clinical signs are those of hypoproteinemia with a fluid volume overload, Plasbumin-25 together with a diuretic may play a role in therapy.

With the relatively small priming volume required with modern pumps, preoperative dilution of the blood using albumin and crystalloid has been shown to be safe and well-tolerated. Although the limit to which the hematocrit and plasma protein concentration can be safely lowered has not been defined, it is common practice to adjust the albumin and crystalloid pump prime to achieve a hematocrit of 20% and a plasma albumin concentration of 2.5 g per 100 mL in the patient.

In the uncommon situation of rapid loss of liver function with or without coma, administration of albumin may serve the double purpose of supporting the colloid osmotic pressure of the plasma as well as binding excess plasma bilirubin.

The administration of Plasbumin-25 may be indicated prior to exchange transfusion, in order to bind free bilirubin, thus lessening the risk of kernicterus. A dosage of 1 g/kg body weight is given about 1 hour prior to exchange transfusion. Caution must be observed in hypervolemic infants.

This occurs in such conditions as acute peritonitis, pancreatitis, mediastinitis, and extensive cellulitis. The magnitude of loss into the third space may require treatment of reduced volume or oncotic activity with an infusion of albumin.

Albumin may be required to avoid excessive hypoproteinemia, during certain types of exchange transfusion, or with the use of very large volumes of previously frozen or washed red cells. About 25 g of albumin per liter of erythrocytes is commonly used, although the requirements in preexistent hypoproteinemia or hepatic impairment can be greater. Plasbumin-25 is added to the isotonic suspension of washed red cells immediately prior to transfusion.

Certain patients may not respond to cyclophosphamide or steroid therapy. The steroids may even aggravate the underlying edema. In this situation a loop diuretic and 100 mL Plasbumin-25 repeated daily for 7 to 10 days may be helpful in controlling the edema and the patient may then respond to steroid treatment.

Although not part of the regular regimen of renal dialysis, Plasbumin-25 may be of value in the treatment of shock or hypotension in these patients. The usual volume administered is about 100 mL, taking particular care to avoid fluid overload as these patients are often fluid overloaded and cannot tolerate substantial volumes of salt solution.

In chronic nephrosis, infused albumin is promptly excreted by the kidneys with no relief of the chronic edema or effect on the underlying renal lesion. It is of occasional use in the rapid "priming" diuresis of nephrosis. Similarly, in hypoproteinemic states associated with chronic cirrhosis, malabsorption, protein losing enteropathies, pancreatic insufficiency, and undernutrition, the infusion of albumin as a source of protein nutrition is not justified.


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NEWS HIGHLIGHTS

Media Articles Related to Plasbumin-25 (Albumin)

A Long Period Of Fasting May Be Unnecessary For Children Undergoing Surgery
Source: GastroIntestinal / Gastroenterology News From Medical News Today [2009.10.29]
Blood glucose levels in many patients fed normal liquid food (NLF) and a high calorie diet (HCD) were high. There was no significant difference in the blood prealbumin levels. There was a significant increase in the blood cortisol levels in some patients. The stress of surgery may be tolerated by children by feeding up to 2 h before elective surgery. A research article published in the World Journal of Gastroenterology addresses this problem.

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.

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Published Studies Related to Plasbumin-25 (Albumin)

Effect of modest salt reduction on blood pressure, urinary albumin, and pulse wave velocity in white, black, and Asian mild hypertensives. [2009.09]
A reduction in salt intake lowers blood pressure. However, most previous trials were in whites with few in blacks and Asians...

Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials. [2009.07.07]
BACKGROUND: Microalbuminuria in diabetes is strongly predictive of nephropathy, end-stage renal disease, and premature cardiovascular morbidity and mortality. Effective preventive therapies are therefore a clinical priority. OBJECTIVE: To determine whether the angiotensin-receptor blocker candesartan compared with placebo affects microalbuminuria incidence or rate of change in albuminuria in type 1 and type 2 diabetes... CONCLUSION: Candesartan, 32 mg/d, for 4.7 years did not prevent microalbuminuria in mainly normotensive patients with type 1 or type 2 diabetes.

Time-dependent variations in ischemia-modified albumin levels in mesenteric ischemia. [2009.06]
OBJECTIVES: The objective was to determine the value of ischemia-modified albumin (IMA) in the diagnosis of mesenteric embolism. The authors investigated whether or not plasma IMA levels rose in the acute period in a rat model of mesenteric ischemia and the related time-dependent changes... CONCLUSIONS: These preliminary findings suggest that serum IMA levels may represent a significant parameter in the early diagnosis of acute mesenteric ischemia and that further studies are necessary. (c) 2009 by the Society for Academic Emergency Medicine.

Albumin versus normal saline for dehydrated term infants with metabolic acidosis due to acute diarrhea. [2009.06]
To compare the efficacy of albumin to normal saline (NS) for initial hydration therapy for dehydrated term infants with severe metabolic acidosis due to acute diarrhea... CONCLUSION: Albumin was not more effective than NS for initial hydration treatment of dehydrated term infants with metabolic acidosis due to acute diarrhea.

Effect of Albumin Administration Prior to Exchange Transfusion in Term Neonates with Hyperbilirubinemia A Randomized Controlled Trial. [2009.05.20]
OBJECTIVE: To determine the role of intravenous administration of human albumin prior to blood exchange in term neonates for reduction of total serum bilirubin (TSB)... CONCLUSION: Infusion of 20% albumin (1 g/kg) one hour prior to blood exchange can significantly reduce the postexchange total serum bilirubin and duration of phototherapy.

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Clinical Trials Related to Plasbumin-25 (Albumin)

Determination of a Safe Dose of Optison in Pediatric Patients With Solid Tumors [Suspended]

St. Jude Children's Research Hospital is studying ways to make ultrasound images clearer - to

be able to see blood vessels, body structures, and tumors better. Ultrasound uses sound waves to create pictures, allowing doctors and other medical professionals to "see" inside the body.

Researchers are studying a contrast agent (like a dye) called Optison™. St. Jude Children's Research Hospital researchers want to learn the best and safest dose of this ultrasound "dye."

Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration [Completed]
This study will evaluate visual improvement in patients treated with Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).

Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis [Completed]
The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period.

Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [Completed]
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measured by INCAT scores. Patients who deteriorate or show no improvement between day 16 and month 6 will receive the alternate study drug for an additional 6 months.

Alpha-1-Antitrypsin (AAT) To Treat Emphysema In AAT-Deficient Patients [Completed]
The goal of this trial was to explore the utility of evaluating emphysema progression through CT scans measuring lung density during a 2 year period of weekly infusions of either placebo or human alpha-1-antitrypsin (AAT; Prolastin®). Exacerbation data recorded in patient diaries were also collected. All efficacy data were analyzed for potential use in evaluating Prolastin efficacy in this and other clinical trials.

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Page last updated: 2009-10-29

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