High volume peritoneal dialysis vs daily hemodialysis: A randomized, controlled trial in patients with acute kidney injury

There is no consensus in the literature on the best renal replacement therapy (RRT) in acute kidney injury (AKI), with both hemodialysis (HD) and peritoneal dialysis (PD) being used as AKI therapy. However, there are concerns about the inadequacy of PD as well as about the intermittency of HD complicated by hemodynamic instability. Recently, continuous replacement renal therapy (CRRT) have become the most commonly used dialysis method for AKI around the world. A prospective randomized controlled trial was performed to compare the effect of high volume peritoneal dialysis (HVPD) with daily hemodialysis (DHD) on AKI patient survival. A total of 120 patients with acute tubular necrosis (ATN) were assigned to HVPD or DHD in a tertiary-care university hospital. The primary end points were hospital survival rate and renal function recovery, with metabolic control as the secondary end point. Sixty patients were treated with HVPD and 60 with DHD. The HVPD and DHD groups were similar for age ( 64.2 +/- 19.8 and 62.5 +/- 21.2 years), gender ( male: 72 and 66%), sepsis ( 42 and 47%), hemodynamic instability ( 61 and 63%), severity of AKI ( Acute Tubular Necrosis-Index Specific Score (ATN-ISS): 0.68 +/- 0.2 and 0.66 +/- 0.2), Acute Physiology, Age, and Chronic Health Evaluation Score (APACHE II) (26.9 +/- 8.9 and 24.1 +/- 8.2), pre-dialysis BUN (116.4 +/- 33.6 and 112.6 +/- 36.8mg per 100 ml), and creatinine ( 5.8 +/- 1.9 and 5.9 +/- 1.4 mg per 100 ml). Weekly delivered Kt/V was 3.6 +/- 0.6 in HVPD and 4.7 +/- 0.6 in DHD ( P<0.01). Metabolic control, mortality rate ( 58 and 53%), and renal function recovery ( 28 and 26%) were similar in both groups, whereas HVPD was associated with a significantly shorter time to the recovery of renal function. In conclusion, HVPD and DHD can be considered as alternative forms of RRT in AKI.

Attenuation of neuropsychiatric symptoms and caregiver burden in Alzheimer's disease by motor intervention: a controlled trial

OBJECTIVE: To analyze the effects of motor intervention on the neuropsychiatric symptoms of Alzheimer's disease and on the caregivers' burden. DESIGN: This is a controlled trial evaluating the effects of a motor intervention program on the neuropsychiatric symptoms. SETTING: The intervention was performed on community patients from two university centers specializing in physical exercise for the elderly. SUBJECTS: Patients with Alzheimer's disease were divided into two groups: sixteen received the motor intervention and sixteen controls (five controls were excluded because of clinical intercurrences). INTERVENTIONS: Aerobic exercises (flexibility, strength, and agility) and functional balance exercises were conducted over six months for 60 minutes three times per week. MAIN MEASURES: Psychopathological features of patients were evaluated with the Neuropsychiatric Inventory and Cornell Scale for Depression in Dementia. Caregivers were evaluated using the Neuropsychiatric Inventory-Distress and Burden Interview. A two-way analysis of variance (ANOVA) was applied to observe interactions (pre- vs. post-intervention; participants vs. controls). RESULTS: Patients from the intervention presented a significant reduction in neuropsychiatric conditions when compared to controls (Neuropsychiatric Inventory: F: 11.12; p = 0.01; Cornell Depression scale: F: 11.97; p = 0.01). The burden and stress of caregivers responsible for patients who participated in the intervention significantly decreased when compared to caregivers responsible for controls (Neuropsychiatric Inventory-Distress: F: 9.37; p = 0.01; Burden Interview: F: 11.28; p = 0.01). CONCLUSIONS: Aerobic exercise was associated with a reduction in the neuropsychiatric symptoms and contributed to attenuate the caregivers' burden. However, the researchers were not blinded to the patient's intervention status, which constitutes an important limitation of this study.

A controlled clinical trial on the effects of exercise on neuropsychiatric disorders and instrumental activities in women with Alzheimer's disease

OBJETIVO: Analisar os efeitos de seis meses de intervenção de um programa de atividade física sobre os distúrbios neuropsiquiátricos e o desempenho nas atividades instrumentais da vida diária de idosos com Doença de Alzheimer (DA). MÉTODOS: Foram recrutados 20 pacientes nos estágios entre leve e moderado da DA. Segundo o escore clínico de demência (CDR), foram distribuídos em dois grupos: o grupo treinamento (GT), composto por dez mulheres que participaram de um program de exercícios físicos por um período de seis meses, e o grupo controle (GC), composto por dez outras participantes que não realizaram nenhum tipo de intervenção motora estruturada durante o mesmo período. Todas as participantes foram avaliadas por meio do Miniexame do Estado Mental, para obtenção da caracterização cognitiva; Inventário Neuropsiquiátrico, para identificação dos distúrbios neuropsiquiátricos mais prevalentes e Questionário de Atividades Instrumentais de Pfeffer, para verificação do grau de comprometimento funcional. RESULTADOS: Os participantes do GC mostraram uma deterioração tanto no desempenho das atividades instrumentais quanto na intensificação dos distúrbios neuropsiquiátricos, quando comparados os momentos pré e pós-intervenção. CONCLUSÃO: O GT demonstrou uma atenuação da intensificação dos distúrbios neuropsiquiátricos e do desempenho funcional em relação ao grupo sedentário.

Functional dependence and caregiver burden in Alzheimer's disease: a controlled trial on the benefits of motor intervention

Background: Cognitive decline has a negative impact on functional activities in Alzheimer's disease. Investigating the effects of motor intervention with the intent to reduce the decline in functionality is an expected target for patients and caregivers. The aim of this study was to verify if a 6-month motor intervention programme promoted functionality in Alzheimer's patients and attenuated caregivers' burden. Methods: The sample comprised 32 community patients with Alzheimer's disease and their 32 respective caregivers. Patients were divided into two groups: 16 participated in the motor intervention programme and 16 controls. Subjects performed 60 minutes of exercises, three times per week during the 6-month period, to improve flexibility, strength, agility and balance. Caregivers followed the procedures with their patients during this period. Functionality was evaluated by the Berg Functional Balance Scale and the Functional Independence Measure. Caregivers completed the Neuropsychiatric Inventory Caregiver Distress Scale and the Zarit Carer Burden Scale. Two-way ANOVA was used to verify the interaction between time (pre- and post-intervention) and the motor intervention program. Results: While patients in the motor programme preserved their functionality, as assessed by the Functional Independence Measure, the controls suffered a relative decline (motor intervention group: from 109.6 to 108.4 vs controls: from 99.5 to 71.6; P= 0.01). Patients from motor intervention also had better scores than the controls on functional balance assessed by Berg scale (F: 22.2; P= 0.001). As assessed by the Neuropsychiatric Inventory and Zarit scale, burden was reduced among caregivers whose patients participated in the motor intervention programme compared with caregivers whose patients did not participate in this programme (Neuropsychiatric Inventory, caregiver's part: F: 9.37; P= 0.01; Zarit: F: 11.28; P= 0.01). Conclusion: Patients from the motor intervention group showed reduced functional decline compared to the controls, and there was an associated decrease in caregivers' burden.

Antioxidant therapy to prevent preeclampsia - A Randomized controlled trial

OBJECTIVE: To study whether antioxidant supplementation will reduce the incidence of preeclampsia among patients at increased risk.METHODS: A randomized, placebo-controlled, double-blind clinical trial was conducted at four Brazilian sites. Women between 12 0/7 weeks and 19 6/7 weeks of gestation and diagnosed to have chronic hypertension or a prior history of preeclampsia were randomly assigned to daily treatment with both vitamin C (1,000 mg) and vitamin E (400 International Units) or placebo. Analyses were adjusted for clinical site and risk group (prior preeclampsia, chronic hypertension, or both). A sample size of 734 would provide 80% power to detect a 40% reduction in the risk of preeclampsia, assuming a placebo group rate of 21% and alpha=.05. The a level for the final analysis, adjusted for interim looks, was 0.0458.RESULTS: Outcome data for 707 of 739 randomly assigned patients revealed no significant reduction in the rate of preeclampsia (study drug, 13.8% [49 of 355] compared with placebo, 15.6% [55 of 352], adjusted risk ratio 0.87 [95.42% confidence interval 0.61-1.25]). There were no differences in mean gestational age at delivery or rates of perinatal mortality, abruptio placentae, pre-term delivery, and small for gestational age or low birth weight infants. Among patients without chronic hypertension, there was a slightly higher rate of severe preeclampsia in the study group (study drug, 6.5% [11 of 170] compared with placebo, 2.4% [4 of 168], exact P=.11, odds ratio 2.78, 95% confidence interval 0.79-12.62).CONCLUSION: This trial failed to demonstrate a benefit of antioxidant supplementation in reducing the rate of preeclampsia among'patients with chronic hypertension and/or prior preeclampsia.

Short-Term Effects of Using Pedometers to Increase Daily Physical Activity in Smokers: A Randomized Trial

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

SUFENTANIL INTRANASAL COME MEDICACAO PRE-ANESTESICA EM CRIANCAS

Background and objectives: Among the different routes used for the administration of preoperative medication, the intranasal route offers the advantage of a rapid systemic absorption as well as the avoidance of painful intramuscular and intravenous injections. The aim of the present study is to evaluate the efficacy of sufentanil as a preoperative medication for the reduction of anxiety in pediatric patients in addition to its effects on the children's behaviour during the induction of anesthesia. Methods - Thirty patients whose ages ranged from 1 to 9 years old, physical status ASA 1, submitted to elective surgeries participated in the study and received sufentanil (2 μg.kg-1) by the intranasal route as preoperative medication. Using the modified Doughty index, the anxiety level was evaluated at 3 moments: To upon arrival of the child with parents: T5 and T10, five and ten minutes after the administration of the drug respectively. Behaviour during the induction of anesthesia was also evaluated. Induction of anesthesia was performed thiopental or ketamine. Results - The level of anxiety was not lower ten minutes after the administration of sufentanil and no improvement in the quality of the anesthetic induction was observed. Conclusions - Intranasal sufentanil in the doses used in this study did not prove to be efficient in the reduction of the anxiety level nor did it improve the quality of the induction of anesthesia when the period between the drug administration and separation from the parents was only ten minutes.

A randomized and controlled trial about the use of oral isotretinoin for photoaging

Topical retinoids are used to treat photoaging; oral isotretinoin is gold standard for acne; off label indications, including photoaging, have been reported with insufficient evidence of efficacy. This is a randomized controlled phase II trial with clinical and histological assessment to evaluate efficacy and safety of oral isotretinoin for photoaging. Study population was comprised of 32 menopausal or sterilized women, aged 40-55, divided in 2 groups: A (21) received 20mg isotretinoin, 3 times per week, nightly moisturizer, and daily sunscreen, for three months; B (11) just moisturizer/sunscreen. Main outcome measures were: overall clinical assessment; profilometry, corneometer and elasticity tests in periocular regions and left forearm; before/after biopsies from left forearm in patients of B and in 10 randomly selected of A. Microscopic blinded evaluation of epidermal thickness, dermal elastosis, new collagen, p53 epidermal expression was performed by quantitative digital image analysis. All data were submitted to statistical analysis. Clinical evaluation showed slight improvement; profilometry, corneometer and skin elasticity tests presented significant difference in pre/post values (P = 0.001 to 0.028), but no differences between A/B. Histological findings and p53 expression were comparable between groups before treatment (P > 0.1); microscopic analysis showed no differences between groups for most variables, after treatment. Slight but significant difference between A/B for p53 with major reduction post isotretinoin [0.66±0.31 vs. 0.94±0.34 respectively (P = 0.04) was observed. There were minor side effects and no significant laboratory test alterations. We concluded that no significant clinical, microscopic changes but p53 epidermal expression reduction were observed. The role of ultra-violet induced p53 mutation in skin carcinogenesis reinforces retinoids chemoprevention. Oral isotretinoin seemed safe but not effective to treat photoaging. Caution should be considered for women prone to pregnancy. Further controlled studies are necessary. © 2010 The International Society of Dermatology.

Root coverage stability of the subepithelial connective tissue graft and guided tissue regeneration: A 30-month follow-up clinical trial

Objectives: The aim of this study was to compare the long-term clinical effects produced by subepithelial connective tissue graft (SCTG) and guided tissue regeneration combined with demineralized freeze-dried bone allograft (GTR-DFDBA) in the treatment of gingival recessions in a 30-month follow-up clinical trial. Methods: Twenty-four defects were treated in 12 patients who presented canine or pre-molar Miller class I and/or II bilateral gingival recessions. GTR-DFDBA and SCTG treatments were performed in a randomized selection in a split-mouth design. The clinical measurements included root coverage (RC), gingival recession (GR), probing depth (PD), clinical attachment level (CAL) and keratinized tissue width (KTW). These clinical parameters were evaluated at baseline and after 6, 18 and 30 months post-surgery. Results: The changes in RC, GR, PD and CAL did not show significant differences between groups (p > 0.05). Both procedures promoted similar RC (GTR-DFDBA: 87% and SCTG: 95.5%) and similar reduction in GR (GTR-DFDBA: 3.25 mm and SCTG: 3.9 mm), PD (GTR-DFDBA: 1.6 mm and SCTG: 1.2 mm) and CAL (GTR-DFDBA: 4.9 mm and SCTG: 5.0 mm). The increase in KTW was significantly higher (p = 0.02) in the SCTG group (3.5 mm) than in the GTR-DFDBA group (2.4 mm). Conclusions: Both techniques for treatment of gingival recession (SCTG and GTR-DFDBA) lead to favourable and long-term stable results, but SCTG promoted a more favourable increase in keratinized tissue. © 2012 Elsevier Ltd. All rights reserved.

A randomized clinical trial of high volume peritoneal dialysis versus extended daily hemodialysis for acute kidney injury patients

Background: Acute kidney injury (AKI) requiring dialysis in critically ill patients is associated with an in-hospital mortality rate of 50-80 %. Extended daily hemodialysis (EHD) and high volume peritoneal dialysis (HVPD) have emerged as alternative modalities. Methods: A double-center, randomized, controlled trial was conducted comparing EHD versus HVPD for the treatment for AKI in the intensive care unit (ICU). Four hundred and seven patients were randomized and 143 patients were analyzed. Principal outcome measure was hospital mortality, and secondary end points were recovery of renal function and metabolic and fluid control. Results: There was no difference between the two groups in relation to median ICU stay [11 (5.7-20) vs. 9 (5.7-19)], recovery of kidney function (26.9 vs. 29.6 %, p = 0.11), need for chronic dialysis (9.7 vs. 6.5 %, p = 0.23), and hospital mortality (63.4 vs. 63.9 %, p = 0.94). The groups were different in metabolic and fluid control. Blood urea nitrogen (BUN), creatinine, and bicarbonate levels were stabilized faster in EHD group than in HVPD group. Delivered Kt/V and ultrafiltration were higher in EHD group. Despite randomization, there were significant differences between the groups in some covariates, including age, pre-dialysis BUN, and creatinine levels, biased in favor of the EHD. Using logistic regression to adjust for the imbalances in group assignment, the odds of death associated with HVPD was 1.4 (95 % CI 0.7-2.4, p = 0.19). A detailed investigation of the randomization process failed to explain the marked differences in patient assignment. Conclusions: Despite faster metabolic control and higher dialysis dose and ultrafiltration with EHD, this study provides no evidence of a survival benefit of EHD compared with HVPD. The limitations of this study were that the results were not presented according to the intention to treat and it did not control other supportive management strategies as nutrition support and timing of dialysis initiation that might influence outcomes in AKI. © 2012 Springer Science+Business Media Dordrecht.

Trial controlado e randomizado da hidratação oral materna com solução isotônica e água no aumento do índice de líquido amniótico em gestantes com normodramnia

Pós-graduação em Ginecologia, Obstetrícia e Mastologia - FMB

Benefits of Multimodal Exercise Intervention for Postural Control and Frontal Cognitive Functions in Individuals with Alzheimer's Disease: A Controlled Trial

Objective To verify the effects of a systematized multimodal exercise intervention program on frontal cognitive function, postural control, and functional capacity components of individuals with Alzheimer's disease (AD).DesignNonrandomized controlled trial with pre- and posttraining tests in a training group and a control group.SettingKinesiotherapy program for seniors with AD, SAo Paulo State University.ParticipantsConvenience sample of older adults with AD (n=30) were assigned to a training (n=14; aged 78.67.1) and a control (n=16; aged 77.06.3) group.InterventionThe intervention program was structured with the aim of simultaneously promoting better balance and frontal cognitive capacity. The participants attended a 1-hour session three times a week for 16weeks, whereas the control group did not participate in any activity during the same period.MeasurementsFrontal cognitive function was evaluated using the Montreal Cognitive Assessment, the Clock Drawing Test, the Frontal Assessment Battery, and the Symbol Search Subtest. Postural control (center of pressure area) was analyzed under four dual-task conditions. Functional capacity components were analyzed using the Timed Up and Go Test, the 30-second sit-to-stand test, the sit-and-reach test, and the Berg Functional Balance Scale.ResultsIntervention group participants showed a significant increase in frontal cognitive function (P<.001, partial (2)=0.838), with less body sway (P=.04, partial (2)=0.04) during the dual tasks, and greater functional capacity (P=.001, partial (2)=0.676) after the 16-week period.ConclusionIntervention participants performed better on dual-task activities and had better postural balance and greater functional capacity than controls.

Icodextrin reduces insulin resistance in non-diabetic patients undergoing automated peritoneal dialysis: results of a randomized controlled trial (STARCH)

Insulin resistance is a common risk factor in chronic kidney disease patients contributing to the high cardiovascular burden, even in the absence of diabetes. Glucose-based peritoneal dialysis (PD) solutions are thought to intensify insulin resistance due to the continuous glucose absorption from the peritoneal cavity. The aim of our study was to analyse the effect of the substitution of glucose for icodextrin on insulin resistance in non-diabetic PD patients in a multicentric randomized clinical trial. This was a multicenter, open-label study with balanced randomization (1:1) and two parallel-groups. Inclusion criteria were non-diabetic adult patients on automated peritoneal dialysis (APD) for at least 3 months on therapy prior to randomization. Patients assigned to the intervention group were treated with 2L of icodextrin 7.5%, and the control group with glucose 2.5% during the long dwell and, at night in the cycler, with a prescription of standard glucose-based PD solution only in both groups. The primary end-point was the change in insulin resistance measured by homeostatic model assessment (HOMA) index at 90 days. Sixty patients were included in the intervention (n = 33) or the control (n = 27) groups. There was no difference between groups at baseline. After adjustment for pre-intervention HOMA index levels, the group treated with icodextrin had the lower post-intervention levels at 90 days in both intention to treat [1.49 (95% CI: 1.23-1.74) versus 1.89 (95% CI: 1.62-2.17)], (F = 4.643, P = 0.03, partial η(2) = 0.078); and the treated analysis [1.47 (95% CI: 1.01-1.84) versus 2.18 (95% CI: 1.81-2.55)], (F = 7.488, P = 0.01, partial η(2) = 0.195). The substitution of glucose for icodextrin for the long dwell improved insulin resistance measured by HOMA index in non-diabetic APD patients.

A mixed model QTL analysis for sugarcane multiple-harvest-location trial data

Sugarcane-breeding programs take at least 12 years to develop new commercial cultivars. Molecular markers offer a possibility to study the genetic architecture of quantitative traits in sugarcane, and they may be used in marker-assisted selection to speed up artificial selection. Although the performance of sugarcane progenies in breeding programs are commonly evaluated across a range of locations and harvest years, many of the QTL detection methods ignore two- and three-way interactions between QTL, harvest, and location. In this work, a strategy for QTL detection in multi-harvest-location trial data, based on interval mapping and mixed models, is proposed and applied to map QTL effects on a segregating progeny from a biparental cross of pre-commercial Brazilian cultivars, evaluated at two locations and three consecutive harvest years for cane yield (tonnes per hectare), sugar yield (tonnes per hectare), fiber percent, and sucrose content. In the mixed model, we have included appropriate (co)variance structures for modeling heterogeneity and correlation of genetic effects and non-genetic residual effects. Forty-six QTLs were found: 13 QTLs for cane yield, 14 for sugar yield, 11 for fiber percent, and 8 for sucrose content. In addition, QTL by harvest, QTL by location, and QTL by harvest by location interaction effects were significant for all evaluated traits (30 QTLs showed some interaction, and 16 none). Our results contribute to a better understanding of the genetic architecture of complex traits related to biomass production and sucrose content in sugarcane.

Emtricitabine-Tenofovir Concentrations and Pre-Exposure Prophylaxis Efficacy in Men Who Have Sex with Men

Drug concentrations associated with protection from HIV-1 acquisition have not been determined. We evaluated drug concentrations among men who have sex with men in a substudy of the iPrEx trial (1). In this randomized placebo-controlled trial, daily oral doses of emtricitabine/tenofovir disoproxil fumarate were used as pre-exposure prophylaxis (PrEP) in men who have sex with men. Drug was detected less frequently in blood plasma and in viable cryopreserved peripheral blood mononuclear cells (PBMCs) in HIV-infected cases at the visit when HIV was first discovered compared with controls at the matched time point of the study (8% versus 44%; P < 0.001) and in the 90 days before that visit (11% versus 51%; P < 0.001). An intracellular concentration of the active form of tenofovir, tenofovir-diphosphate (TFV-DP), of 16 fmol per million PBMCs was associated with a 90% reduction in HIV acquisition relative to the placebo arm. Directly observed dosing in a separate study, the STRAND trial, yielded TFV-DP concentrations that, when analyzed according to the iPrEx model, corresponded to an HIV-1 risk reduction of 76% for two doses per week, 96% for four doses per week, and 99% for seven doses per week. Pro-phylactic benefits were observed over a range of doses and drug concentrations, suggesting ways to optimize PrEP regimens for this population.