Daniel Camilo Aguirre

Unfractioned heparin for treatment of sepsis: A randomized clinical trial (The HETRASE Study).

Objective: The primary aims of this study were to determine the effects of heparin on length of stay and change from baseline multiple organ dysfunction (MOD) score. Secondary objectives were to estimate the effects of heparin on 28-day all-cause mortality, and to determine the possible effect modification on 28-day all-cause mortality, in subgroups defined by site of infection and baseline values of Acute Physiology and Chronic Health Evaluation II score, MOD score, and d-dimer. Design: Randomized, double-masked, placebo-controlled, single-center clinical trial, testing low dose continuous infusion of unfractioned heparin (UFH) as complementary treatment for sepsis. Setting: Five hundred fifty bed University Hospital and referral center in Medellín, Columbia. Patients: Three hundred nineteen patients admitted at the emergency room with signs indicative of sepsis. Interventions: Patients were randomly assigned to receive placebo or UFH (500 units/hour for 7 days). Measurements and Main Results: The median length of stay in patients discharged alive in the placebo group was 12.5 days (interquartile range = 8–20), and 12 days (interquartile range = 8–19.5) in the heparin group (p = 0.976). The MOD score improved equally in the two treatments arms with an average decline of 0.13 and 0.11 per day for the placebo and heparin groups (p = 0.240), respectively. The overall 28-day mortality was 16% in the placebo group and 14% in the heparin group (p = 0.652). Subgroup analyses did not show any statistically significant reduction in 28-day mortality with UFH. There was only one serious adverse event on a patient who received heparin but it was fully resolved without complications. Conclusions: Our findings suggested that UFH may be a feasible and safe intervention in sepsis. However, this study was not able to demonstrate a beneficial effect on the chosen primary outcomes or in the 28-day mortality rate.

Histoplasmosis en pacientes con sida. Un estudio de cohorte en Medellín, Colombia

Introduction: histoplasmosis is an endemic mycosis in Colombia and a relatively common complication in HIV patients. The aim of this study was to identify clinical and epidemiological characteristics and mortality risk factors in patients infected with histoplasmosis and HIV. Materials and methods: a retrospective cohort study was carried out at Hospital Universitario San Vicente de Paul in Medellin with 1177 HIVpositive patients. Patients with histoplasmosis were confirmed by isolation of Histoplasma capsulatum from culture or by identification of intracellular yeasts through microscopy. Data collected from patients included demographic and clinical variables, laboratory values, treatment, and survival. Results: histoplasmosis affected 44/709 patients with AIDS (6.2%). Out of those, 95.4% had fever, 54.5% disseminated illness, and 61.3% pulmonary disease. Culture was positive in 89.3%, and histopathology in 93.3%. Concomitant tuberculosis and Pneumocystis jirovecii infection were diagnosed in 15.9% and 11.4%, respectively. General mortality was 22.7%. Mortality was higher in patients with disseminated forms (all 10 deaths occurred in this fashion), dyspnea (RR 13; 95% CI 1.8-93.8), hypotension (RR 4.5; 95% CI 1.6-13.1), lactate dehydrogenase >2 times the upper limit of the normal range (RR 5.2; 95% CI 1.2-22.5), and it was lower among patients treated with amphotericine B (RR 0.3; 95% CI 0.1-0.8). Discusion: histoplasmosis is frequent in AIDS patients in the region. As the diagnosis yield of routine techniques to identify H. capsulatum is high, they must be required in any compatible setting. Many patients with AIDS-histoplasmosis co-infection acquire other opportunistic infections. Patients with disseminated forms, dyspnea, hypotension, and high levels of DHL have a higher mortality risk. Exposure to amphotericine B is associated with longer survival.

Diseño y análisis comparativo de un inventario de indicadores de mortalidad evitable adaptado a las condiciones sanitarias de Colombia

OBJETIVOS: Elaborar un inventario de indicadores de mortalidad evitable (INIME) que permita analizar las fallas en el control de los riesgos de mortalidad predominantes en Colombia y comparar los resultados de su aplicacion con los obtenidos mediante dos enfoques ampliamente utilizados. METODOS: Se revisaron los registros oficiales de mortalidad de Colombia de 1985 a 2001; las causas basicas de muerte se clasificaron segun la CIE-9. Se seleccionaron los indicadores de mortalidad evitable (ME) mediante un algoritmo que combino las listas de Holland y de Taucher, la definicion de Rutstein y colaboradores y el principio de Uemura. Se compararon las proporciones de muertes evitables resultantes de aplicar el INIME y las dos listas de ME a una base de datos con los registros oficiales de defunciones de Colombia de 1993 a 1996. RESULTADOS: De las 680617 defunciones registradas en el periodo de estudio, se clasificaron como evitables 18,2% segun la lista de Holland y 51,3% segun la lista de Taucher. La ME segun el INIME ascendio a 76,7%. Este patron se mantuvo relativamente estable entre 1993 y 1996. Las diferencias observadas en la proporcion de muertes evitables segun el INIME y las dos listas de ME se relacionaron con el perfil epidemiologico local y el enfoque conceptual de cada lista. CONCLUSIONES: Las diferencias entre el INIME y las listas de ME de Holland y de Taucher muestran las consecuencias de usar una u otra clasificacion en el contexto colombiano. El INIME puede constituir un recurso valioso para fundamentar y evaluar politicas sanitarias, pero debe ajustarse a la situacion especifica en que se aplique.

A randomized clinical trial of unfractioned heparin for treatment of sepsis (the HETRASE study): design and rationale [NCT00100308].

IntroductionInfection promotes coagulation via a large number of molecular and cellular mechanisms, and this procoagulant activity has boosted basic and clinical research using anticoagulant molecules as therapeutic tools in sepsis. Heparin, which is a naturally occurring proteoglycan that acts by reducing thrombin generation and fibrin formation, has not been rigorously tested in a randomized clinical trial.MethodsRandomized, double-masked, placebo-controlled, single-center clinical trial. Patients are recruited through the emergency room at Hospital Universitario San Vicente de Paul. This is a 650-bed University Hospital in Medellín, Colombia and is a referral center for a region with approximately 3 million habitants. The recruitment process started on July 2005 and will finish on June 2007. Patients aged 18 years or older, males or females, hospitalized with clinically or microbiological confirmed sepsis, have been included. The interventions are unfractioned heparin in low dose continuous infusion (500 units per hour for 7 days) or placebo, additionally to the standard of care for sepsis patients in Colombia.ResultsOur primary aims are to estimate the effects of heparin on hospital length of stay and change from baseline Multiple Organ Dysfunction (MOD) score. Secondary objectives are to estimate the effects of heparin on 28-day all-cause mortality, and to estimate the possible effect modification on 28-day all-cause mortality, in subgroups defined by source and site of infection, and baseline values of APACHE II score, MOD score and D-dimer.ConclusionThe available literature in animal and human research, and the understanding of the molecular biology regarding inflammation and coagulation, supports a randomized clinical trial for the use of heparin in sepsis. Our study will provide appropriate power to detect differences in valid surrogate outcomes, and it will explore important preliminary data for efficacy regarding the clinical end-point of mortality.

Cuestionario de efectividad de la psicoterapia Outcome Questionnaire. Validación en muestra clínica colombiana

Establecer las propiedades estructurales y psicometricas del OQ-45.2 e identificar la sensibilidad al cambio y diferencias segun genero. Metodo: se realizo en poblacion clinica, participaron 214 consultantes (111 hombres y 103 mujeres), Instrumento: Outcome Questionnaire (OQ-45.2). Resultados: El AFC mostro indices de bondad de ajuste bajos y valor de RMSEA de 0.071. Se recomendo realizar el AFE, y esta estructura incluyo 20 items y explico el 58,8 % de la varianza total: preocupacion, problemas del desempeno del rol social, insatisfaccion global, alcohol/drogas, dificultades en las relaciones e insatisfaccion en las relaciones afectivas. Para la escala original, los coeficientes se encontraron entre 0.52 y 0.92; no se presentaron diferencias segun genero en ninguno de los factores pero si sensibilidad al cambio en la terapia en todas las dimensiones. Para la estructura encontrada a traves del AFE con 20 items, los coeficientes se encontraron entre 0.47 y 0.75. Los indices de ajustes para esta nueva estructura fueron muy favorables (CFI=0,920, TLI=0,902 y NFI=0,790) y valor de RMSEA de 0.046. Se reportaron diferencias con relacion al genero en las dimensiones Insatisfaccion global (mas elevadas en mujeres) y Alcohol/droga (puntuaciones mas elevadas en hombre). La prueba reporto sensibilidad al cambio en la escala original en Estres, Desempeno y Relaciones interpersonales negativas, y en la escala abreviada en Preocupacion, Problemas del rol social e Insatisfaccion en las relaciones afectivas. Conclusiones: el OQ 45.2 no presento una estructura adecuada a traves del AFC. El AFE reporto 6 factores y 20 items, adecuados indices de ajustes, pero no todos los factores con buen nivel de confiabilidad.