Enhancing the Implementation of the Virtual Pediatric Trauma Center Using Practical, Robust, Implementation and Sustainability Model: A Mixed-Methods Study.

Background: This article describes factors related to adoption, implementation, and effectiveness of the Virtual Pediatric Trauma Center intervention, which uses telehealth for trauma specialist consultations for seriously injured children. We aimed at (1) measuring RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) implementation outcomes and (2) identifying PRISM (Practical, Robust, Implementation, and Sustainability Model) contextual factors that influenced the implementation outcomes.

Methods: This interim implementation evaluation of our telehealth trial used a convergent mixed-methods design.

Pharmacokinetics and tolerability (Study 1) with particular reference to ocular safety (Study 2) of tiotropium Respimat soft mist inhaler: findings from two dose-ranging studies in healthy men.

Data are presented from two randomized, double-blind, placebo-controlled studies in which the tolerability of tiotropium Respimat Soft MistTM Inhaler (SMI), a new-generation, propellant-free device for use in COPD, and the ocular safety oftiotropium were examined. In Study 1, 36 healthy males received tiotropium 8, 16, or 32 microg (n = 9/dose) or placebo (n = 3/dose level), administered once daily via Respimat SMI for 14 days. Safety and pharmacokinetics were evaluated.

Pharmacokinetics of intravenous, single-dose tiotropium in subjects with different degrees of renal impairment.

Tiotropium, a new potent anticholinergic bronchodilator, is excreted mainly by the kidney. To investigate the pharmacokinetics of tiotropium in renal impairment, the authors evaluated the pharmacokinetics and safety after administration of a single dose of intravenous tiotropium 4.8 microg, given as an infusion over 15 minutes in subjects with normal renal function and a wide range of renal impairment based on measured creatinine clearance (normal: > 80 mL/min, n = 6; mild impairment: > 50-80 mL/min, n = 5; moderate impairment: 30-50 mL/min, n = 7; severe impairment: < 30 mL/min, n =6).

Pharmacokinetics and tissue distribution of the anticholinergics tiotropium and ipratropium in the rat and dog.

Ipratropium, a current treatment for chronic obstructive pulmonary disease (COPD) and tiotropium, a longer acting anticholinergic bronchodilator currently being developed for COPD are structurally related to atropine. In this study, the intravenous (i.v.

Tiotropium (Spiriva): mechanistical considerations and clinical profile in obstructive lung disease.

Inhaled antimuscarinics, often called anticholinergics in clinical medicine, are established as first line bronchodilators in COPD. Tiotropium has been developed as a new generation antimuscarinic following ipratropium. Tiotropium is a specific, highly potent antimuscarinic, demonstrating very slow dissociation from muscarinic receptors.

Effects of clonidine in a primed rat model of acute hepatic porphyria.

Acute hepatic porphyrias can be induced by several drugs and acute attacks of porphyrias are often associated with severe hypertension. Therefore it is important to know if an antihypertensive drug used has porphyrogenic potency or not. As previously demonstrated in normal rats the alpha-receptor blocker clonidine (CAS 4205-90-7) has no significant influence on the porphyrin metabolism.

Pharmacokinetics and pharmacodynamics of beta 2-agonists (in the light of fenoterol).

As an example of beta 2-agonists fenoterol was used in this study on 27 patients with chronic obstructive airways diseases (COAD). After refraining from any kind of bronchodilator during 12 h the patients were given the drug in a crossover design in three groups. Using aerosol inhalation, intravenous route and nasal instillation we measured the response of airway resistance, intrathoracic gas volume and fenoterol plasma concentrations.

Influence of clonidine on the porphyrin metabolism in female rats.

Effects of different doses of clonidine (CAS 4205-90-7) (15, 150, or 300 micrograms/kg body weight) over a period of 3, 14, or 64 days on the activities of delta-aminolevulinic acid synthase (ALA-S) and the P450 dependent isoenzymes aminopyrine-N-demethylase (ADM), 7-ethoxycoumarin-O-deethylase (7-ECO-D), and 7-ethoxyresorufin-O-deethylase (7-ERO-D) as well as on the hepatic porphyrin and P450 content were studied in female rats. Additionally, the urinary excretion of total porphyrins, and porphyrin precursors delta-aminolevulinic acid (ALA) and porphobilinogen (PBG) and the plasma clonidine level were measured. No changes in the activity of ALA-S and in the hepatic and urinary porphyrin, ALA and PBG contents were observed.

Pharmacokinetic/dynamic correlation of pulmonary and cardiac effects of fenoterol in asthmatic patients after different routes of administration.

Pulmonary and cardiac effects of the beta 2-adrenergic drug fenoterol were studied in 27 asthmatic patients using an integrated pharmacokinetic/dynamic (PK/PD) approach. Airway resistance (Rf), intrathoracic gas volume (IGV), heart rate, and plasma levels were monitored after placebo, injection (12.5 and 25 micrograms), nasal instillation (400 micrograms), inhalation (200 and 400 micrograms), and infusion (200 micrograms/180 min with or without loading dose).

Clenbuterol plasma concentrations after repeated oral administration and its effects on cardio-respiratory and blood lactate responses to exercise in healthy Standardbred horses.

To evaluate the effects of clenbuterol on cardio-respiratory parameters and blood lactate relation to exercise tolerance, experimental horses performed standardized exercise tests on a high-speed treadmill before and after administration of the drug. Clenbuterol was administered in feed to six healthy Standardbreds at a dose rate of 0.8 micrograms/kg b.

[Pharmacokinetics of clonidine following intravenous administration of high doses for the treatment of delirium tremens].

Concentrations of clonidine (CAS 4205-09-7. Catapresan) were measured in the plasma and the urine of 6 patients with delirium tremens who received 1.8-13.

Radioimmunological determination of fenoterol. Part II: Antiserum and tracer for the determination of fenoterol.

A radioimmunological method for the determination of the concentration of fenoterol in biological samples is described. The mixture of antibodies against the enantiomers of fenoterol obtained with the selected hapten shows a high affinity for racemic fenoterol and for the monoiodo125-fenoterol used as a tracer, which is also present as a racemate. The limit of detection of the radioimmunoassay for fenoterol (racemate) in biological samples (plasma, urine) is 10-20 pg/ml.

[Maternal plasma concentrations in multiple oral fenoterol treatment].

Reports on the clinical effectiveness of oral treatment with beta-sympathomimetic fenoterol are quite divergent in their conclusions. The aim of this study was to determine the plasma levels of fenoterol in steady state during tocolytic treatment with high oral doses. Nine pregnant women with clinically indicated tocolysis were given a 5 mg dose of fenoterol in tablet form eight times per day at prescribed hours.

[Oral tocolytic therapy with clenbuterol--clinical facts].

Clenbuterol is a betamimetic agent with a marked effect on the adrenergic beta-2-receptors relevant for tocolysis. The influence on beta-1-receptors of the heart, resulting in cardiovascular side effects is far less. The substance is resorbed almost completely enterally and has a half-life of 34 hours.

[Oral tocolytic therapy with clenbuterol--determination of the plasma level].

12 pregnant women with premature labor received tocolytic treatment with clenbuterol tablets. Initially, 2 clenbuterol tablets (40 micrograms each) were to be given as loading dose (application interval = 12 hours), then a dose reduction was planned (40 micrograms), to be followed by a maintenance dose of 20 micrograms. The mean values of plasma levels of clenbuterol hydrochloride during the day ranged between 0.

Radioimmunological determination of fenoterol. Part I: Theoretical fundamentals.

A general solution is given for the system of equations describing coupled mass equilibria having m antibodies with one binding site, or with several mutually independent binding sites of equal intrinsic affinity (immunoglobulin (Ig) G antibodies) and n monovalent antigens. Based on this a formula is given with which it is possible to calculate the minimum association constant of the antibody and the minimum specific radioactivity of the tracer in a radioimmunoassay when the detection limit is given and the assay conditions are established. The model m = 2 and n = 4 describes the behaviour of a system which is based on a mixture of stereoselective antibodies and a racemic tracer.

Proof of the linearity of the pharmacokinetics of alinidine in man.

The pharmacokinetics of alinidine was investigated in two groups of volunteers: Group I (N=5) received on two occasions single doses of 14C-labelled drug given orally (40 mg) or intravenously (10 mg); Group II (N=6) received single oral doses 10, 30, or 90 mg dissolved in 20 ml water. The samples from Group I were analysed by two different and independent methods (RIA and counting total radioactivity). The results obtained by the two methods were identical, since the compound was not metabolized.

Pharmacokinetic comparison of etilefrine to its prodrug, the stearic acid ester of etilefrine.

The relative bioavailability of a prodrug of etilefrine, its stearic acid ester, was determined by means of plasma levels and renal excretion. The comparison of the plasma levels and renal excretion was carried out in a cross-over design in six subjects. 3H-etilefrine (20 mg) and 3H-2-etylamino-1-(3-stearoylphenyl)ethanol hydrochloride (44.

[Plasma levels, renal excretion and metabolism of orciprenaline after administration in sustained-release form (author's transl)].

A newly developed sustained-release form of orciprenaline-sulfate (Alupent) was tested in 13 patients. Determination of 3H-radioactivity in blood, urine and faeces was used to elucidate its pharmacokinetic properties. Maximum plasma levels of radioactivity were obtained between 8 and 12 h after administration.

[Metabolite isolation for mass spectrometrical determination of new drugs (author's transl)].

Only very minute concentrations of metabolites of highly effective and consequently low dosed drugs can be detected in urine. In order to identify the structure of these compounds they must be concentrated by a factor up to 1:10(6). Isolation of metabolites, especially when present as conjugates, becomes more complicated the greater the polarity.

Absorption, distribution and excretion of the tritium-labelled beta2 stimulator fenoterol hydrobromide following aerosol administration and instillation into the bronchial tree.

The administration by aerosol of fenoterol hydrobromide (Berotec) was investigated in four test persons. Two patients with operable carcinomas of the lung were given tritium-labelled fenoterol hydrobromide aerosol immediately before undergoing surgery. Parts of the pulmonary segments removed were biochemically analysed and it was observed that the radioactive contents in pulmonary tissue and blood plasma were almost identical.

Mass spectral analysis of glucuronides from sympathomimetic hydroxyphenylalkylaminoethanols.

A mass spectral method is described for the structure determination of glucuronic acid conjugates of hydroxyphenylalkylaminoethanol-type drugs. Trimethylsilylation and application of the GLC-mass spectral technique yield mass spectra with sufficient information for the identification of all structural subunits.