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Trophamine (Amino Acid Injection) - Summary

 
 



TROPHAMINE SUMMARY

TrophAmine (6% and 10% Amino Acid Injections) are sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids. All amino acids designated USP are the "L"-isomer with the exception of Glycine USP, which does not have an isomer.

TrophAmine is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients where (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance. See WARNINGS, PRECAUTIONS, Pediatric Use, and DOSAGE AND ADMINISTRATION.

Central Venous Nutrition

Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted infants, or those requiring long-term parenteral nutrition.

Peripheral Parenteral Nutrition

For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5 to 10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).


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NEWS HIGHLIGHTS

Media Articles Related to Trophamine (Amino Acid Injection)

Injuries from indoor tanning include burns, passing out, eye injuries
Source: Public Health News From Medical News Today [2014.12.18]
Skin burns, passing out and eye injuries were among the primary injuries incurred at indoor tanning sites and treated in emergency departments (EDs) at U.S.

Indoor Tanning Can Lead to Burns, Fainting, Eye Injuries
Source: Medscape Dermatology Headlines [2014.12.16]
Indoor tanning can send people to the emergency room for burns, eye injuries and fainting, according to U.S. health officials.
Reuters Health Information

Indoor Tanning Tied to Burns, Fainting, Eye Injuries: Study
Source: MedicineNet Burns Specialty [2014.12.16]
Title: Indoor Tanning Tied to Burns, Fainting, Eye Injuries: Study
Category: Health News
Created: 12/15/2014 12:00:00 AM
Last Editorial Review: 12/16/2014 12:00:00 AM

Tracking neutrophil motility patterns could provide early diagnosis of sepsis in patients with major burns
Source: Dermatology News From Medical News Today [2014.12.13]
A team of Massachusetts General Hospital (MGH) investigators has identified what may be a biomarker predicting the development of the dangerous systemic infection sepsis in patients with serious...

Night shift work burns less energy and increases risk of weight gain
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2014.11.19]
People who work the night shift are likely burning less energy during a 24-hour period than those on a normal schedule, increasing their risk for weight gain and obesity, according to a new study led...

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Published Studies Related to Trophamine (Amino Acid Injection)

Skeletal muscle is anabolically unresponsive to an amino acid infusion in pediatric burn patients 6 months postinjury. [2011.03]
OBJECTIVE: To evaluate leg muscle, whole-body muscle, and whole-body nonmuscle protein response to anabolic signaling of amino acids in pediatric burn patients at 6 months after injury. BACKGROUND: Burn injury is associated with a catabolic state persisting years after the injury. The tissue response to nutritional signaling (eg, amino acids) plays a critical role in tissue protein net balance via coordination of protein synthesis and breakdown mechanisms... CONCLUSION: In pediatric burn patients at 6 months postinjury, leg muscle protein net deposition is unresponsive to amino acid infusion; and whole-body protein breakdown is significantly higher than in the control group.

Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response. [2010.08.25]
PI-2301 is an immunomodulator that could be an alternative therapy for MS. A placebo-controlled, multiple-ascending dose, double-blind study was performed in patients with secondary-progressive MS... MRI data indicated a non-significant trend for a reduction of lesion numbers in subjects treated with 1 and 3 mg PI-2301.

Results of a phase I study in patients suffering from secondary-progressive multiple sclerosis demonstrating the safety of the amino acid copolymer PI-2301 and a possible induction of an anti-inflammatory cytokine response. [2010]
PI-2301 is an immunomodulator that could be an alternative therapy for MS. A placebo-controlled, multiple-ascending dose, double-blind study was performed in patients with secondary-progressive MS... The most common adverse event was transient injection site reactions.

Effects of dimethylaminoethanol pyroglutamate (DMAE p-Glu) against memory deficits induced by scopolamine: evidence from preclinical and clinical studies. [2009.12]
RATIONALE: Dimethylaminoethanol pyroglutamate (DMAE p-Glu) is a compound resulting from the reaction between dimethylaminoethanol (an indirect precursor of acetylcholine) and pyroglutamic acid (a cyclic derivative of glutamic acid having procholinergic properties and promnesic effects in both animals and man). OBJECTIVES: The present study undertook preclinical and clinical evaluations to test a potential therapeutic utility for DMAE p-Glu in cognitive impairments related to central cholinergic deficit... CONCLUSION: These results indicate that DMAE p-Glu reduces the deleterious effect of scopolamine on long-term memory in healthy volunteers and suggest that DMAE p-Glu might be effective in reducing memory deficits in patients with cognitive impairment.

[Investigation on treatment of fetal growth restriction by salvia injection combined with composite amino acid] [2009.01]
OBJECTIVE: To explore the effect of salvia injection (SI) combined with composite amino acid (CAA) in treating fetal growth restriction (FGR)... CONCLUSION: The combined treatment with SI and CAA on FGR could improve the condition of the fetus.

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Clinical Trials Related to Trophamine (Amino Acid Injection)

Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates [Not yet recruiting]
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene solution develop TPN-associated cholestasis in a smaller proportion than those who received Trophamine solution.

Local Effects of Amino Acids, Leucine and 3-hydroxybutyrate in the Bilaterally Perfused Human Leg [Recruiting]
Introduction: Protein loss during critical illness is an important problem and is shown to predict overall survival. In animal studies, infusion of leucine is shown to increase the synthesis of muscle protein by 30-40% and decrease protein degradation by 30%. Animal studies also show that after administrating 3-hydroxybutyrate (3-OHB), cardiac output increase, and O2 consumption decrease. Humane studies show 10% increase in protein synthesis and 30% decrease in protein degradation after administration of 3-OHB.

Objectives: Compared to saline, an amino acid infusion in the femoral artery will promote protein synthesis and inhibit breakdown assessed with local a/v phenylalanine and tyrosine tracer kinetics in healthy volunteers. These effects will be further amplified by leucine and 3-OHB enrichment and will include distinct alterations in muscle signal events, in particular mTOR.

Methods: n = 4 x 8 healthy male subjects are equipped with catheters in aa. femorales and vv. femorales bilaterally under local anaesthetics. Each study comprises a 3-hour basal period and a 3-hour period with hyperinsulinaemic-euglucaemic clamp. During the test, samples of arterial and venous blood and 4 muscle biopsies are obtained. The 4 different studies contain continues saline infusion compared to either (i) amino acids (Vamin), (ii) Vamin + leucine, (iii) Vamin + 3-OHB or (iiii) Vamin + leucine + 3-OHB.

Perspectives: This study elucidates whether infusion of aminoacids, leucin and 3-hydroxybutyrate can diminish protein loss and thereby potentially improve the nutrition of all critically ill patients.

Gut Hormones After Oral Versus Intravenous Amino Acids [Recruiting]
The study hypothesis is that gut hormones are released after oral but not intravenous amino acids which result in stimulation of insulin secretion.

Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis [Recruiting]
Malnutrition, including muscle wasting commonly occurs in children with cystic fibrosis (CF), negatively influencing their quality of life and survival. At the time of a diagnosis of CF, severe protein deficits can already be present. It is important to get CF children fed adequately to prevent that their condition becomes worse or that recovery takes longer. Oral supplementation trials showed that gains in lean body mass are difficult to achieve in CF unless specific metabolic abnormalities are targeted. However, the specific needs for certain food components are not clear yet in children that are ill. Therefore, more information is necessary on the need for protein and certain amino acids in children with CF. Previous studies support the concept of essential amino acids (EAA) as an anabolic stimulus in the young and elderly and in insulin resistant states. Until yet no information is present on the anabolic effects of EAA in CF.

It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically designed to stimulate protein anabolism will target the metabolic alterations of pediatric subjects with CF. In the present proposal, the acute metabolic effects of this high leucine essential amino acids mixture will be examined in pediatric subjects with CF and compared to that of a regular balanced total mixture of essential and non-essential amino acids. The principal endpoints will be the extent of stimulation of whole body protein synthesis as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be assessed by isotope methodology which is thought to be the reference method.

Modulation of Systemic Inflammatory Response in Critically Ill Children After Glutamine Supplementation [Recruiting]
This study aims to describe the use of glutamine supplementation in the modulation of inflammatory response in critically ill pediatric patients and to determine if this decrease leads to clinical improvement in morbidity and mortality in these patients. Thus, these patients' diet could be supplemented with glutamine in order to improve their evolution.

Hypothesis:

From the data obtained in the study of the literature the investigators consider that:

Critically ill patients have a deficit of glutamine either because of an increase in its consumption or a decrease in its availability, and therefore blood glutamine levels are low.

Critically ill patients have elevated blood levels of pro-inflammatory substances (IL-6).

In these patients tissue lesion inhibitors (HSP-70) in the blood are decreased. The administration of glutamine supplements to these patients decreases oxidative stress due to the increase in HSP-70.

Inflammation inhibitory substances (IL-10) in the blood are decreased in these patients.

The administration of glutamine supplements in these patients increase IL-10 levels.

Glutamine supplements decrease the inflammatory response with a decrease in IL-6 levels.

more trials >>


Page last updated: 2014-12-18

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