RESUMO
OBJECTIVE: To assess whether dexamethasone (DXM) decreases the time to recovery in patients with parapneumonic pleural effusion. STUDY DESIGN: This was a multicenter, randomized, double blind, parallel-group, placebo-controlled clinical trial of 60 children, ranging in age from 1 month to 14 years, with community-acquired pneumonia (CAP) and pleural effusion. Patients received either intravenous DXM (0.25?mg/kg/dose) or placebo every 6 hours over a period of 48 hours, along with antibiotics. The primary endpoint was the time to recovery in hours, defined objectively. We also evaluated complications and adverse events. RESULTS: Among the 60 randomized patients (mean age, 4.7 years; 58% female), 57 (95%) completed the study. Compared with placebo recipients, the patients receiving DXM had a shorter time to recovery, after adjustment by severity group and stratification by center (hazard ratio, 1.95; 95% CI, 1.10-3.45; P?=?.021). The median time to recovery for patients receiving DXM was 68 hours (2.8 days) shorter than patients receiving placebo (109 hours vs 177 hours; P?=?.037). In exploratory subgroup analysis, the median time to recovery for patients with simple effusion receiving DXM was 76 hours (3.1 days) shorter than for patients with simple effusion receiving placebo (P?=?.017). The median time to recovery for patients with complicated effusion receiving DXM was 14 hours (0.5 days) shorter than for patients with complicated effusion receiving placebo (P?=?.66). The difference in the effect of DXM in the 2 severity groups was not statistically significant (P?=?.138 for interaction). There were no significant differences in complications or adverse events attributable to the study drugs, except for hyperglycemia. CONCLUSION: In this trial, DXM seemed to be a safe and effective adjunctive therapy for parapneumonic pleural effusion. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01261546.
Assuntos
Dexametasona/uso terapêutico , Glucocorticoides/uso terapêutico , Derrame Pleural/tratamento farmacológico , Antibacterianos/uso terapêutico , Proteína C-Reativa/análise , Pré-Escolar , Infecções Comunitárias Adquiridas/tratamento farmacológico , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pneumonia/tratamento farmacológico , Modelos de Riscos Proporcionais , Recuperação de Função Fisiológica , Fatores de TempoRESUMO
OBJECTIVE: To gather information for a future confirmatory trial of dobutamine (DB) for circulatory impairment (ie, low superior vena cava [SVC] flow). STUDY DESIGN: A total of 127 infants born at < 31 weeks gestational age were serially scanned from birth to 96 hours after birth. The infants were randomly assigned to 2 groups and were treated with DB (stepwise dose increase, 5-10-15-20 µg/kg/min) or placebo if they had an SVC flow < 41 mL/kg/min within the first 24 hours after birth. The primary outcome measures were the achievement and maintenance of an SVC flow ≥ 41 mL/kg/min. Secondary outcome measures were the short-term evolution of clinical and biochemical variables, near-infrared spectroscopy, cranial Doppler ultrasound, and clinical outcomes. RESULTS: SVC flow increased throughout the first 96 hours for the entire cohort. All of the randomized infants (n = 28) except 2 achieved and maintained an SVC flow ≥ 41 mL/kg/min after intervention; however, the infants treated with DB (n = 16) showed a higher heart rate and improved base excess compared with those treated with placebo (n = 12). Low SVC flow was associated with low gestational age (P = .02) and poor condition at birth (P = .02). Low SVC flow significantly increased the risk of severe ischemic events (OR, 13; 95% CI, 2.4-69.2; P < .01). CONCLUSION: This exploratory trial demonstrates a tendency toward improved short-term clinical and biochemical perfusion variable outcomes in infants with low SVC flow treated with DB. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01605279) and the European Clinical Trials Database (EurodraCT 2009-010901-35).
Assuntos
Agonistas de Receptores Adrenérgicos beta 1/uso terapêutico , Cardiotônicos/uso terapêutico , Dobutamina/uso terapêutico , Fluxo Sanguíneo Regional/efeitos dos fármacos , Veia Cava Superior/efeitos dos fármacos , Agonistas de Receptores Adrenérgicos beta 1/administração & dosagem , Velocidade do Fluxo Sanguíneo/efeitos dos fármacos , Velocidade do Fluxo Sanguíneo/fisiologia , Cardiotônicos/administração & dosagem , Dobutamina/administração & dosagem , Ecocardiografia Doppler , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Projetos Piloto , Espanha , Espectroscopia de Luz Próxima ao Infravermelho , Resultado do Tratamento , Veia Cava Superior/fisiologiaRESUMO
OBJECTIVE: To describe an alternative analysis in the frequency-domain of the temporal relationship between 2 biological signals and evaluate the method's predictive capacity for classifying infants at risk for an adverse outcome. STUDY DESIGN: We studied 54 infants (mean gestational age 27 weeks) with invasive mean arterial blood pressure monitoring. The bivariate autoregressive spectral coherence (BiAR-COH) method and the spectral coherence methods were used to analyze the relationship between spontaneous changes in mean arterial blood pressure and the near-infrared tissue oxygenation index. RESULTS: The mean postnatal age at the beginning and end of the autoregulation study was 6.0 (3.0) and 29.0 (7.5) hours, respectively. The BiAR-COH was superior to the spectral coherence in predicting low superior vena cava (SVC) flow (≤ 41 mL/kg per minute), with an area under the receiver operating characteristic curve of 0.84 (95% CI, 0.77-0.90; P < .001). The BiAR-COH threshold for identifying low SVC flow was 0.577, with 0.8 sensitivity and 0.76 specificity. After adjusting for the repeated measures effect (multiple epochs) in a given patient, the averaged BiAR-COH per patient and averaged COH per patient were calculated as the average value per patient. The pBiAR-COH (but not the pCOH) was associated with intraventricular hemorrhage grades 3 and 4 and predicted mortality. CONCLUSIONS: The BiAR-COH classifier identifies low SVC flow infants who are at risk for brain hypoperfusion. The BiAR-COH is superior to frequency domain methods in predicting adverse outcomes in infants.
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Pressão Arterial/fisiologia , Encéfalo/fisiopatologia , Circulação Cerebrovascular/fisiologia , Homeostase/fisiologia , Oxigênio/sangue , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Masculino , Estudos Prospectivos , Curva ROC , Medição de Risco , Espectroscopia de Luz Próxima ao Infravermelho , Veia Cava Superior/fisiologiaRESUMO
BACKGROUND/AIMS: The study investigates esophageal motor function and esophageal clearance immediately after surgical induction of reflux in piglets and 8 weeks later after peptic esophagitis has developed. METHODS: Twenty-four sedated, nonintubated piglets were divided into three groups: sham (laparotomy only), reflux (distal esophageal myotomy), and reflux + esophagitis (8 weeks after myotomy). All animals underwent stationary manometry of the esophagus with a four-lumen perfused assembly after injection of 1-, 2-, and 3-mL boluses of saline and acid into the proximal esophagus. Simultaneous pH monitoring allowed assessment of acid clearance. Wave features and clearance times after saline and acid were compared among groups. RESULTS: There were minor changes in peristaltic activity of the esophagus after saline boluses in animals with reflux. Acid clearance time was prolonged, especially the time to re-establish resting esophageal pH, in animals with esophagitis. These changes, which were volume-dependent, were related to the loss of peristaltic organization of the esophageal waves. The esophageal wave frequency, amplitude, and duration were only slightly changed by the induction of reflux and by esophagitis. CONCLUSIONS: The esophagus affected by acid reflux, with or without esophagitis, was capable of near-normal motor responses after boluses of saline. Reflux impaired the peristaltic response to acid, and the effect was more pronounced when reflux and esophagitis were both present. The acid clearance time was also strikingly prolonged in the presence of reflux and esophagitis. The results suggest that long episodes of reflux seen on pH tracings from individuals with esophagitis might be secondary both to acid-related motor dysfunction and large volumes of refluxate.
Assuntos
Esofagite/fisiopatologia , Esôfago/fisiologia , Ácido Gástrico/metabolismo , Refluxo Gastroesofágico/fisiopatologia , Peristaltismo , Animais , Modelos Animais de Doenças , Motilidade Gastrointestinal , Concentração de Íons de Hidrogênio , Masculino , Manometria , Distribuição Aleatória , SuínosRESUMO
BACKGROUND/AIMS: The present study investigates manometrically in healthy piglets whether esophageal clearance after distension with different volumes of acid is volume-dependent. METHODS: Sedated, non-intubated piglets (n = 22) underwent stationary manometry of the esophagus with a 4-probe perfused assembly after successive injection of 1, 2, and 3 mL of saline and acid. Simultaneous pH metering allowed assessment of acid clearance. Wave features and clearance times after saline and acid were compared by paired non-parametric tests and Friedman analysis of variance. The linearity of the relationships between the clearance times and the volumes of acid infused were tested after square root transformations by one-way ANOVA repeated measures. The significance level was set at < 0.05. RESULTS: The motor response was identical after distension with saline and acid except for the largest amount of acid used, which elicited more waves during the first 5 minutes after infusion. Time elapsed until regaining pH4 was longer after higher amounts of acid, but not significantly, whereas that necessary to regain baseline pH was significantly longer after such challenge. Esophageal motility was practically identical after 1 and 2 mL of acid, but it was slightly less effective in the first minute after the 3 mL challenge. There was a linear correlation between clearance times and volumes of acid infused. CONCLUSIONS: Up to a certain volume, the motor responses of the healthy esophagus to distension with neutral or acid fluids were similar. Acid clearance was more a function of the amount of acid present than of the motor response elicited by its presence. Only when the amount of acid was large, esophageal motor response was worse than that elicited after equivalent volumes of neutral fluid. The present evidence suggests that long episodes of reflux in pH tracings might reflect large volumes of refluxate as well as disturbed motor function.