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Biomedical subjects

M Neuhäuser

Publications and source records attributed to M Neuhäuser.

26 records · Page 2Linked to original sources
PubMed1980

Urinary excretion of 3-methylhistidine as an index of muscle protein catabolism in postoperative trauma: the effect of parenteral nutrition.

The effect of different intravenous nutritional regimens on nitrogen balance and 3-methylhistidine (3-MeHIS) excretion were studied during a 6-day period following major elective surgery in 28 patients. All patients were kept on a synthetic diet 4 days prior to surgery and were given 0.1 g amino acid N and 120 kJ/kg . day. Postoperatively, all patients received parenteral nutrition with approximately 170 kJ/kg . day. Postoperatively, all patients received parenteral nutrition with approximately 170 kJ/kg . day. Three groups of patients were given varying amounts and proportions of amino acids while in one group no amino acids were administered. Preoperatively, urinary 3-MeHIS excretion (determined by a newly developed automatic analyzer) was 240.3 mumole/day +/- 9.2, nitrogen balance was -1.8 g N +/- 0.19. Postoperatively, nitrogen balance was less negative when amino acids were given. The degree of improvement depended on the amount, but not on the composition of nitrogen administered. In all four groups, 3-MeHIS outputs were elevated when compared with preoperative excretion. The 3-MeHIS excretion (mumole/day) was increased more in patients on high amino acid supply than in patients with low or no nitrogen supply. In each of the groups the 3-MeHIS excretion was negatively correlated to the nitrogen balance. Regression analyses suggest that postoperative muscle protein breakdown occurs in relation to the body protein loss. Amino acid administration seems not to decrease muscle protein breakdown, but rather, appears to stimulate protein synthesis, resulting in less net protein loss. The mean rate of muscle protein breakdown in the postoperative state was estimated to be 80 g/day, assuming 4.2 mumole 3-MeHIS per g mixed human muscle protein. This exceeded the mean preoperative breakdown by about 23 g muscle protein per day. This increase might be due to the metabolic response to the trauma and also in part to tissue damage by the surgical procedure.

Aged↗
PubMed1980

Biochemical changes associated with severe trauma.

The effects of different intravenous nutritional regimens on a number of biochemical indices of nutritional status were studied during the 8-day period following severe trauma. The inclusion of large amounts of amino acids (high nitrogen (N) was shown to greatly improve N balance over an isocaloric regimen containing no amino acids (O g N). The concentration of serum albumin, transferrin, prealbumin, and retinol-binding protein all fell during the study period in both patient groups, whereas the serum concentrations of acute phase reactants and of ribonuclease increased in the two groups. The sum of plasma levels of branched-chain amino acids and the essential amino acids was increased to a greater extent in the high N group. These amino acid totals and the ratio of glycine/valine showed a significant correlation with N balance in this group. Despite the marked difference in N balance, 3-methylhistidine excretion was increased but equal in the two nutritional groups, suggesting an increased rate of muscle protein breakdown in both groups, which appears not to be influenced by amino acid nutrition. It is concluded that N balance can be significantly improved in the immediate posttrauma period by provision of amino acids together with energy substrates. None of the biochemical variables measured, with the exception of plasma levels of essential amino acids, reflected these marked differences in N balance.

Adult↗
PubMed1978

Influence of essential amino acids and keto acids on protein metabolism and anemia of patients on intermittent hemodialysis.

Ten patients were treated with 10 g/day of essential amino acids orally; nine patients received 9.5 g/day of a mixture of essential amino acids (lysine, threonine, tryprophan, histidine, and tyrosine) and keto analogues of isoleucine, leucine, phenylalanine, valine, and methionine. A control group of 11 patients received no supplementation. All patients were on a liberal food intake amounting to 1 g of protein per kilogram of body weight and 31 kcal/kg of body weight daily. Before and 3 months after the beginning of the supplementation, the following parameters were measured: amino acids, albumin, transferrin, urea and creatinine concentrations in plasma, hemoglobin, and hematocrit in blood. None of these parameters was altered by either treatment. It is concluded that supplementation with essential amino acids or their keto analogues is ineffective in well-nourished dialysis patients.

Administration, Oral↗
PubMed1977

Influence of essential amino acids and keto acids on protein metabolism and the anaemia of patients on chronic intermittent haemodialysis.

Ten patients were treated with 10 g essential amino acids per day orally; 9 patients received 9.5 g of a mixture of essential amino acids (Lys, Thr, Try, His, Tyr) and ketoanalogues of Ile, Leu, Phe, Val, Met per day and a control group of 11 patients received no supplementation. All patients were on a liberal food intake amounting to 1g protein/kg body weight and 31 kcal/kg body weight daily. Before and three months after the beginning of supplementation the following parameters were measured: serum concentrations of albumin, transferrin, urea, creatinine, blood haemoglobin content and haematocrit, activities of the enzymes delta-aminolevulinic acid dehydrase and porpho-bilinogen desaminase, and globin synthesis in peripheral red blood cells. After treatment with either essential amino acids or keto acids a significant stimulation of globin synthesis occurred. None of the other parameters was altered. It is concluded that in well-nourished patients supplements of essential amino acids or keto acids are ineffective.

Amino Acids, Essential↗
PubMedDate not supplied

Equivalence concepts in clinical trials.

According to the recent ICH E9 Guidance Statistical Principles for Clinical Trials, efficacy is most convincingly established by demonstrating superiority to placebo, by showing superiority to an active control treatment or by demonstrating a dose-response relationship (so-called 'superiority' trials). For serious illnesses, a placebo-controlled trial may be considered unethical if a therapeutic treatment exists which has proven efficacious in relevant superiority trial(s). In that case, the scientifically sound use of an active treatment as a control should be considered. Active control trials designed to show that the efficacy of an investigational product is not relevantly worse than that of the active comparator are called 'non-inferiority' trials (1). After having confirmed non-inferiority, superiority of the alternative test treatment over the reference treatment can additionally be tested without the need to adjust the significance level (2). In contrast to cross-over bioequivalence trials based on pharmacokinetic endpoints such as AUC and Cmax, therapeutic equivalence and non-inferiority trials are based on clinical end-points. Therefore, they are often conducted as parallel group comparisons. It is important to note that the conclusion of equivalence or non-inferiority is based on the inclusion of the appropriate confidence interval in the equivalence acceptance range, and that it cannot be derived from a non-significant test result of the inappropriate null hypothesis of no treatment difference.

Clinical Trials as Topic↗