Donación de órganos en asistolia controlada tipo III de Maastricht en una unidad de cuidados intensivos pediátricos / Organ donation after circulatory determination of death (Maastricht type III donation) in a pediatric intensive care unit. A case report

Actualmente la actividad de donación es insuficiente para suplir las necesidades de trasplante de órganos de nuestra población. Este desequilibrio entre la oferta y la demanda de órganos humanos para trasplante ha condicionado la puesta en marcha de programas hospitalarios de donación en asistolia (DA) controlada tipo III de Maastricht. Los pacientes evaluables como potenciales donantes en asistolia tipo III son aquellos en los que dado su mal pronóstico vital se decide la retirada del tratamiento de soporte vital (RTSV) y fallecen tras el cese irreversible de la circulación y la respiración en un plazo de tiempo inferior a dos horas después de su aplicación, en ausencia de contraindicación médica y de oposición expresa a la donación. Aunque la principal fuente de obtención de órganos continúa siendo a partir de pacientes en muerte encefálica, la DA controlada ofrece otra posibilidad de obtener órganos (especialmente riñones) y tejidos. Ésta precisa de un equipo multidisciplinar y un proceso de donación técnicamente diferente, enmarcado siempre dentro de protocolos clínicos hospitalarios multidisciplinares vigentes avalados por la ONT y en nuestro caso la OCATT (Organització Catalana de Trasplantaments). A continuación presentamos el caso clínico de una paciente ingresada en nuestra UCI pediátrica en la que se realizó una RTSV debido a su situación catastrófica, y que resultó donante de órganos en asistolia tipo III de Maastricht. En nuestro conocimiento es el primer caso de DA tipo III en una UCI pediátrica en Cataluña

Currently, organ donation rates are insufficient to cover the transplant needs in our population. This has led to the design of a hospital program of organ donation after circulatory determination of death (Maastricht type III donation). Potential donors for this program are those whose vital support is decided to withdraw due to their very severe vital prognosis, given that there is not medical contraindication and the family is not opposed to the donation. These patients will die within 2 hours of withdrawing their ventilatory and circulatory support. Although the main source of organ recovery for transplantation must still be patients with brain death, organ donation after circulatory determination of death offers more chances for obtaining organs (especially kidneys) and tissues. This situation requires a multidisciplinary team, specific techniques and hospital guidelines and protocols for this donation process. This must be protocoled following the guidelines of the ONT (Organización Nacional de Trasplantes) and the OCATT (Organització Catalana de Trasplantaments). We report the case of a patient treated in the paediatric ICU for acute intracranial hypertension related to cerebral venous thrombosis in the setting of an acute middle ear infection. The severe clinical situation evolved to withdrawal of life support. She became donor as a type III in the Maastricht donor classification. To the best of our knowledge, this is the first case of asystole donation in a paediatric ICU in Catalonia

Bioequivalence study of 2 orodispersible formulations of ondansetron 8 mg in healthy volunteers.

This study was designed to compare the rate and extent of absorption of 2 oral formulations of ondansetron (CAS 99614-02-5) 8 mg orodispersible tablets in healthy volunteers. 22 subjects were administered ondansetron orodispersible tablets of test and reference formulation in a single-dose, 2-period, 2-sequence, fasting, open-label, crossover and randomised study. Plasma concentrations were determined by LC/MS/MS. Log-transformed AUCs and Cmax values were tested for bioequivalence based on the ratios of the geometric means (test/reference). Tmax was analysed nonparametrically. The 90% confidence intervals of the geometric mean values for the test/reference ratios for AUC0-t and Cmax were within the bioequivalence acceptance range of 80-125%. According to the European Guideline [1] it may be therefore concluded that test formulation of ondansetron 8 mg orodispersible tablet is bioequivalent to the reference formulation.

Bioequivalence evaluation of two strengths of risperidone tablet formulations in healthy volunteers.

OBJECTIVE: The objective of the study was to evaluate bioequivalence of two strengths (1 and 2 mg) of oral risperidone tablet formulations (test product manufactured by Vita-Invest, S.A., Barcelona, Spain, reference product manufactured by Janssen-Cilag Ltd., UK). SUBJECTS AND METHODS: In each of the 2 studies, 30 healthy volunteers were administered 1 or 2 mg, respectively, of test or reference formulation under fasting conditions in an open, two-way crossover, controlled, randomized and single-site fashion. Blood withdrawal was performed prior to dosing as well as 15 min, 30 min, 1 h, 1.5 h, 2 h, 3 h, 5 h, 8 h, 12 h, 16 h, 24 h, 48 h, 72 h, and 96 h after drug administration. Plasma concentrations of risperidone and its metabolite 9-hydroxy-risperidone were analyzed using LC/MS/MS. Descriptive data of AUC0-t, AUC0- yen, Cmax, and Cmax/AUC0- yen were log-transformed to evaluate bioequivalence based on the ratios of the geometric means of test and reference formulations. tmax was analyzed using nonparametric methods. RESULTS: The results show that in both studies, 1 and 2 mg formulations, the 90% confidence intervals for the geometric means ratios of the test and reference products for both the parent compound risperidone and its metabolite 9-hydroxy-risperidone were all within the bioequivalence acceptance criteria of 0.80 - 1.25 of the European CPMP and the US FDA guidelines, with the exception of tmax for risperidone parent compound in the 2 mg formulation, which was slightly suprabioequivalent for test formulation. CONCLUSION: This study demonstrated the bioequivalence between the test and the reference product of risperidone of both 1 and 2 mg formulations. Both formulations of each strength may, therefore, be prescribed interchangeably.

[The use of antibiotics in surgical prophylaxis. The characteristics and consequences]. / Utilización de antibióticos en profilaxis quirúrgica. Características y consecuencias.

BACKGROUND: The efficacy of antibiotic prophylaxis in certain surgical procedures has been demonstrated in clinical trials. The present study aimed at getting knowledge on the way how it is used in a certain hospital. METHODS: In a certain day, all patients receiving antibiotics to prevent a postoperative infection were identified in a medical school hospital. Information on the operative procedure, prescribed antibiotics and clinical course of the patients was recorded. RESULTS: Out of 714 patients admitted, 255 (36%) were treated with antibiotics and, of these, 85 were given them to prevent a postoperative infection. In 52% of patients, two or more antibiotics were given. The mean (SD) duration of prophylaxis was 8.4 (8.6) days. It was judged as really indicated in 34 cases (40%). Only in 17 (20%) the first choice antibiotic was selected; in 11 (13%) a preoperative dose of the right antibiotic was administered and only in 3 (3.5%) a preoperative dose of the first choice antibiotic was administered and prophylaxis lasted up to 48 hours. CONCLUSIONS: The use of antibiotics in surgical prophylaxis in a medical school hospital is inappropriate in more than 95% of cases. The situation in other centres should be quantified and the universally accepted norms of prophylaxis should be implemented.