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Unexpectedly prolonged fasting and its consequences on elderly patients undergoing spinal anesthetics. A prospective observational study1.
Yeniay, O, Tekgul, ZT, Okur, O, Koroglu, N
Acta cirurgica brasileira. 2019;(3):e201900309
Abstract
PURPOSE To measure the preoperative fasting durations with respect to time of the day and its effect on vital parameters and electrocardiogram in elderly patients undergoing surgery under spinal anesthesia. METHODS This study investigated 211 patients older than 60 years undergoing elective surgery under spinal anesthesia. Patients scheduled for surgery in morning hours (AM) and afternoon hours (PM) were compared. Patients fasting hours and repeated measurements of mean arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation (Sp02) and the type and number of ischemic electrocardiogram (ECG) signs were recorded and compared [preoperative, zeroth, 2nd,5th,15th,30th minutes following spinal anesthesia(SA)]. RESULTS Mean fasting durations were 12±2.8 and 9.5±2.1 hours in AM group and 15.5±3.4 12.7±4.4 hours in PM group for foods and liquids respectively. ECG changes were significantly more frequent in PM group and body temperatures were significantly higher in AM group patients. CONCLUSION Our study has shown that fasting times in our population is far longer than recommended and fasting prolonged>15 hours is related to a transiently increased cardiac stress and mild hypothermia.
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Oxygen saturation and heart rate in premature: comparison between cup and finger feeding techniques.
Nunes, JA, Bianchini, EMG, Cunha, MC
CoDAS. 2019;(6):e20180221
Abstract
PURPOSE To evaluate the oxygen saturation, heart rate, length of hospital stay and weight preterm infants or preterm newborns (PTNBs) (in the Neonatal Intensive Care Unit in the diet supply by cup and finger feeding techniques, simultaneously with breastfeeding. METHODS Simultaneous randomized clinical trial. Twenty-five preterm infants admitted to the Neonatal Intensive Care Unit of the Public Hospital from October 2011 to February 2012 were selected. The sample was divided into two groups: Eight preterm infants who received the diet in the cup probe group (CPG) who were born on the same day, and 17 by finger probe group (FPG) who were born on the odd day. In the diet offer, the minimum and maximum values of oxygen saturation (O2 Sat) and heart rate (HR) were recorded: before offering the diet, during and after the offer. RESULTS Regarding the variables O2 Sat and HR, no statistically significant differences were observed between the groups, but in the group vs time factor, the groups showed differences, not continuous in the O2 Sat variable. Regarding weight, a statistically significant gain was observed for both groups, and in CPG the highest weight gain was due to the longer hospitalization time. It was verified that FPG presented shorter hospitalization time. CONCLUSION There were no differences regarding O2 Sat and HR. However, when analyzing the time factor, the groups presented some differences, not continuous, indicating the need for other studies for a better understanding of the effect. The FPG presented shorter hospitalization time and the CPG infants had greater weight gain due to longer hospitalization time.
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Cardiovascular phenotyping for personalized lifestyle treatments of chronic abdominal pain in Irritable Bowel Syndrome: A randomized pilot study.
Davydov, DM, Shahabi, L, Naliboff, B
Neurogastroenterology and motility. 2019;(12):e13710
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Abstract
BACKGROUND Different physical exercise interventions for pain and other related symptoms largely follow non-personalized guidelines and show a high degree of variability in outcome. These interventions are considered to have different pathways toward improvement in autonomic regulation of energy metabolism. The current pilot study was conducted to assess the predictive value of individual cardiovascular (CV) activity markers at rest to predict clinical outcomes for two popular exercise-based interventions (walking and yoga) in patients with Irritable Bowel Syndrome (IBS). METHODS Twenty-seven adult participants with IBS were randomly assigned to a 16-biweekly Iyengar yoga or walking program. They completed pre- and post-treatment assessments on IBS symptom severity, affective and somatic complaints, and various measures of resting autonomic function including blood pressure (BP), heart rate and its variability, baroreceptor sensitivity (BRS) to activations and inhibitions with gains of brady- and tachycardiac baro-responses, and BP start points for these spontaneous baroreflexes. RESULTS Pretreatment BRS was differentially related to clinical response for the treatment groups. Specifically, a significant decrease in pain severity was found in response to yoga for those participants who had lower resting BRS to activations, but decreased pain severity was associated with higher resting BRS for those in the walking group. The effect was not related to affective symptom relief. Other CV measures showed similar associations with clinical outcomes for both groups. CONCLUSIONS The data suggest therefore that CV based phenotypes may be useful in personalizing clinical interventions for IBS. They may also point to autonomic mechanisms that are targets for such interventions.
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The effect of caffeine on cutaneous postocclusive reactive hyperaemia.
Melik, Z, Princi, T, Grill, V, Cankar, K
PloS one. 2019;(4):e0214919
Abstract
BACKGROUND Caffeine is reported to be the most widely used pharmacologically active substance. It causes mental stimulation and increases blood pressure. Acute systolic and diastolic blood pressure response to caffeine attenuates in the course of regular caffeine use; tolerance to cardiovascular responses develops in some people. For some hypertension-prone people coffee ingestion may be harmful, and for others it may be beneficial. The aim of our work was to evaluate the effect of caffeine on postocclusive reactive hyperaemia (PORH), a test of microvascular function, and at the same time to monitor the central effects of caffeine on blood pressure and heart rate. METHODS Heart rate, arterial pressure, and cutaneous laser-Doppler (LD) flux were monitored in 32 healthy volunteers (aged 25.2 ± 4.3 years) before and after they ingested 200 mg of caffeine. LD flux was measured on a finger at rest and after the release of an 8-minute occlusion of digital arteries above the place of LD flux measurement. All parameters obtained after the ingestion of caffeine were compared to the values obtained before caffeine and to the values obtained after a placebo. RESULTS We found slightly increased arterial pressure as well as decreased heart rate and resting LD flux (Dunnett's test, p<0.05) after the ingestion of caffeine. Caffeine significantly reduced the PORH response (Dunnett's test, p<0.01). The power of the low-frequency oscillations (0.06-0.15 Hz) of LD flux, representing vascular myogenic activity, increased significantly after the ingestion of caffeine at rest and during the PORH response. A correlation was found between the number of cups of coffee regularly consumed and resting LD flux values (R = 0.492, p = 0.00422), peak LD flux values during PORH (R = 0.458, p = 0.00847), and the PORH area (R = 0.506, p = 0.00313) after caffeine consumption. CONCLUSIONS From the results, we can conclude that caffeine affects cutaneous microvascular function during rest and during a PORH response, and that it increases blood pressure and decreases heart rate.
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A Phase 1, Randomized, Placebo- and Active-Controlled Crossover Study to Determine the Effect of Single-Dose Ertugliflozin on QTc Interval in Healthy Volunteers.
Sahasrabudhe, V, Saur, D, Matschke, K, Terra, SG, Hickman, A, Huyghe, I, Shi, H, Cutler, DL
Clinical pharmacology in drug development. 2018;(5):513-523
Abstract
Ertugliflozin, a selective sodium-glucose cotransporter-2 inhibitor, is being developed for the treatment of type 2 diabetes mellitus. This randomized, 6-sequence, 3-period crossover study assessed the effect of ertugliflozin (100 mg; supratherapeutic dose) vs placebo and moxifloxacin (400 mg; positive control) on the QT interval corrected for heart rate (QTc) in 42 male or female healthy subjects. Triplicate electrocardiograms were performed predose and serially over 48 hours postdose in each treatment period. The maximum observed least-squares mean (90% CI) difference in QTc using the Fridericia correction (QTcF) between ertugliflozin and placebo was 2.99 (1.68, 4.30) milliseconds, 24 hours postdose, below the 5-millisecond threshold of potential clinical concern. The upper limits of the 2-sided 90% CI were less than 10 milliseconds at all postdose time points. The lower 90% CIs for the least-squares mean QTcF difference between moxifloxacin and placebo were greater than 5 milliseconds at the preselected time points of 2, 3, and 4 hours postdose, establishing study sensitivity. The majority of adverse events were mild in severity. In healthy volunteers, at a supratherapeutic dose of 100 mg, ertugliflozin was not associated with QTc interval prolongation.
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Comparison of Two Highly Automated ECG Algorithms for Detection of Drug-Induced Cardiac Ion Channel Block.
Brockway, M, Fossa, AA, Mason, JW
Clinical pharmacology and therapeutics. 2018;(2):356-363
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US Food and Drug Administration (FDA) investigators recently demonstrated in a crossover study that early (J-Tpeak c) and late (Tpeak -Tend ) repolarization duration can differentiate selective potassium block with a high arrhythmia risk from multichannel block with lower risk in subjects receiving dofetilide, verapamil, quinidine, or ranolazine. The purpose of this study was to determine if the findings by the FDA using their published software algorithm could be corroborated using an alternative software algorithm for the same metrics and to determine if methodological differences resulted in clinically meaningful differences in interpretation. Exposure-response relationships computed with linear mixed effects models and mean maximal effects on ECG intervals measured by the two algorithms were similar, corroborating the FDA findings, but with some differences in the modeled slopes and magnitude of changes. The alternative software resulted in an average 25% reduction in the 95% confidence intervals of the mixed effects models with generally lower Akaike Information Criterion values.
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Effects of a high-intensity interval training program versus a moderate-intensity continuous training program on maximal oxygen uptake and blood pressure in healthy adults: study protocol for a randomized controlled trial.
Arboleda Serna, VH, Arango Vélez, EF, Gómez Arias, RD, Feito, Y
Trials. 2016;:413
Abstract
BACKGROUND Participation in aerobic exercise generates increased cardiorespiratory fitness, which results in a protective factor for cardiovascular disease and all-cause mortality. High-intensity interval training might cause higher increases in cardiorespiratory fitness in comparison with moderate-intensity continuous training; nevertheless, current evidence is not conclusive. To our knowledge, this is the first study to test the effect of high-intensity interval training with total load duration of 7.5 min per session. METHODS A randomized controlled trial will be performed on two groups of healthy, sedentary male volunteers (n = 44). The study protocol will include 24 exercise sessions, three times a week, including aerobic training on a treadmill and strength training exercises. The intervention group will perform 15 bouts of 30 s, each at an intensity between 90 % and 95 % of maximal heart rate. The control group will complete 40 min of continuous exercise, ranging between 65 % and 75 % of maximal heart rate. The primary outcome measure to be evaluated will be maximal oxygen uptake (VO2max), and systolic and diastolic blood pressure will be evaluated as secondary outcome measures. Waist circumference, body mass index, and body composition will also be evaluated. DISCUSSION Epidemiological evidence shows the link between VO2max and its association with chronic conditions that trigger CVD. Therefore, finding ways to improve VO2max and reduce blood pressure it is of vital importance to public health. TRIAL REGISTRATION NCT02288403 . Registered on 4 November 2014.
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Acute Effects of Caffeine on Heart Rate Variability, Blood Pressure and Tidal Volume in Paraplegic and Tetraplegic Compared to Able-Bodied Individuals: A Randomized, Blinded Trial.
Flueck, JL, Schaufelberger, F, Lienert, M, Schäfer Olstad, D, Wilhelm, M, Perret, C
PloS one. 2016;(10):e0165034
Abstract
UNLABELLED Caffeine increases sympathetic nerve activity in healthy individuals. Such modulation of nervous system activity can be tracked by assessing the heart rate variability. This study aimed to investigate the influence of caffeine on time- and frequency-domain heart rate variability parameters, blood pressure and tidal volume in paraplegic and tetraplegic compared to able-bodied participants. Heart rate variability was measured in supine and sitting position pre and post ingestion of either placebo or 6 mg caffeine in 12 able-bodied, 9 paraplegic and 7 tetraplegic participants in a placebo-controlled, randomized and double-blind study design. Metronomic breathing was applied (0.25 Hz) and tidal volume was recorded during heart rate variability assessment. Blood pressure, plasma caffeine and epinephrine concentrations were analyzed pre and post ingestion. Most parameters of heart rate variability did not significantly change post caffeine ingestion compared to placebo. Tidal volume significantly increased post caffeine ingestion in able-bodied (p = 0.021) and paraplegic (p = 0.036) but not in tetraplegic participants (p = 0.34). Systolic and diastolic blood pressure increased significantly post caffeine in able-bodied (systolic: p = 0.003; diastolic: p = 0.021) and tetraplegic (systolic: p = 0.043; diastolic: p = 0.042) but not in paraplegic participants (systolic: p = 0.09; diastolic: p = 0.33). Plasma caffeine concentrations were significantly increased post caffeine ingestion in all three groups of participants (p<0.05). Plasma epinephrine concentrations increased significantly in able-bodied (p = 0.002) and paraplegic (p = 0.032) but not in tetraplegic participants (p = 0.63). The influence of caffeine on the autonomic nervous system seems to depend on the level of lesion and the extent of the impairment. Therefore, tetraplegic participants may be less influenced by caffeine ingestion. TRIAL REGISTRATION ClinicalTrials.gov NCT02083328.
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Troponin I levels in permanent atrial fibrillation-impact of rate control and exercise testing.
Horjen, AW, Ulimoen, SR, Enger, S, Norseth, J, Seljeflot, I, Arnesen, H, Tveit, A
BMC cardiovascular disorders. 2016;:79
Abstract
BACKGROUND High-sensitivity troponin I (hs-TnI) and troponin T (hs-TnT) are moderately correlated and independently related to outcome in atrial fibrillation (AF). Rate controlling therapy has been shown to reduce hs-TnT, however the potential impact on hs-TnI levels, and whether this differs from the effects on hs-TnT, has not been investigated previously. METHODS Sixty patients with stable, permanent AF without heart failure or known ischemic heart disease were included in a randomised crossover study (mean age 71 ± 9 years, 18 women). Diltiazem 360 mg, verapamil 240 mg, metoprolol 100 mg, and carvedilol 25 mg were administered once daily for three weeks, in a randomised sequence. At baseline and on the last day of each treatment period, hs-TnI was measured at rest and after a maximal exercise test and compared to hs-TnT. RESULTS Hs-TnI and hs-TnT correlated moderately at baseline (rs = 0.582, p < 0.001). All drugs reduced both the resting and the peak exercise levels of hs-TnI compared with baseline (p < 0.001 for all). The decline in resting hs-TnI and hs-TnT values relative to baseline levels was similar for all drugs except for verapamil, which reduced hs-TnI more than hs-TnT (p = 0.017). Levels of hs-TnI increased significantly in response to exercise testing at baseline and at all treatment regimens (p < 0.001 for all). The relative exercise-induced increase in hs-TnI was significantly larger compared to hs-TnT at baseline (p < 0.001), on diltiazem (p < 0.001) and on verapamil (p = 0.001). CONCLUSIONS In our population of stable, permanent AF patients, all four rate control drug regimens reduced hs-TnI significantly, both at rest and during exercise. The decline in hs-TnI and hs-TnT levels associated with beta-blocker and calcium channel blocker treatment was similar, except for a larger relative decrease in hs-TnI levels following verapamil treatment. TRIAL REGISTRATION www.clinicaltrials.gov ( NCT00313157 ).
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Effect of axitinib on the QT interval in healthy volunteers.
Ruiz-Garcia, A, Houk, BE, Pithavala, YK, Toh, M, Sarapa, N, Tortorici, MA
Cancer chemotherapy and pharmacology. 2015;(3):619-28
Abstract
PURPOSE Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1-3, approved for second-line treatment of advanced renal cell carcinoma (RCC). Preclinical studies did not indicate potential for axitinib-induced delayed cardiac repolarization. METHODS The effect of axitinib on corrected QT (QTc) prolongation was evaluated with one-stage concentration-QTc response modeling using data from a definitive randomized crossover QT phase I study in healthy volunteers administered one single 5-mg axitinib dose alone or in the presence of steady-state ketoconazole (400 mg once daily). RESULTS Axitinib and ketoconazole had opposite effects on heart rate: Axitinib lowered it, ketoconazole raised it. The final analysis showed a flat relationship between QTc and axitinib concentration (slope -0.0314 ms·mL/ng) for axitinib alone. Mean highest placebo-matched change from baseline in QTc was -3.0 [90 % confidence interval (CI) -5.4, -0.6] ms. At supratherapeutic axitinib exposures achieved with potent cytochrome P450 3A4/5 inhibition by ketoconazole, the model predicted mean QTc change of 6.5 (90 % CI 4.4-8.5) ms. The slope population mean estimate was -0.331 (95 % CI -0.860, 0.198) ms·mL/µg for ketoconazole alone and 0.0725 (0.0445-0.1005) ms·mL/ng for axitinib in the presence of ketoconazole. The results were then compared with those obtained based on more widely used Fridericia's, Bazett's, and study-specific correction methods. CONCLUSIONS Since axitinib plasma concentrations observed in this study exceeded the range of concentrations observed in patients with RCC at the highest approved clinical dose (10 mg twice daily), axitinib was not associated with clinically significant QTc prolongation in target populations.