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The effects of stimulation of the autonomic nervous system via perioperative nutrition on postoperative ileus and anastomotic leakage following colorectal surgery (SANICS II trial): a study protocol for a double-blind randomized controlled trial.
Peters, EG, Smeets, BJ, Dekkers, M, Buise, MD, de Jonge, WJ, Slooter, GD, Reilingh, TS, Wegdam, JA, Nieuwenhuijzen, GA, Rutten, HJ, et al
Trials. 2015;:20
Abstract
BACKGROUND Postoperative ileus and anastomotic leakage are important complications following colorectal surgery associated with short-term morbidity and mortality. Previous experimental and preclinical studies have shown that a short intervention with enriched enteral nutrition dampens inflammation via stimulation of the autonomic nervous system and thereby reduces postoperative ileus. Furthermore, early administration of enteral nutrition reduced anastomotic leakage. This study will investigate the effect of nutritional stimulation of the autonomic nervous system just before, during and early after colorectal surgery on inflammation, postoperative ileus and anastomotic leakage. METHODS/DESIGN This multicenter, prospective, double-blind, randomized controlled trial will include 280 patients undergoing colorectal surgery. All patients will receive a selfmigrating nasojejunal tube that will be connected to a specially designed blinded tubing system. Patients will be allocated either to the intervention group, receiving perioperative nutrition, or to the control group, receiving no nutrition. The primary endpoint is postoperative ileus. Secondary endpoints include anastomotic leakage, local and systemic inflammation, (aspiration) pneumonia, surgical complications classified according to Clavien-Dindo, quality of life, gut barrier integrity and time until functional recovery. Furthermore, a cost-effectiveness analysis will be performed. DISCUSSION Activation of the autonomic nervous system via perioperative enteral feeding is expected to dampen the local and systemic inflammatory response. Consequently, postoperative ileus will be reduced as well as anastomotic leakage. The present study is the first to investigate the effects of enriched nutrition given shortly before, during and after surgery in a clinical setting. TRIAL REGISTRATION ClinicalTrials.gov: NCT02175979 - date of registration: 25 June 2014. Dutch Trial Registry: NTR4670 - date of registration: 1 August 2014.
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The degree of autonomic modulation is associated with the severity of microvascular complications in patients with type 1 diabetes.
Fleischer, J, Cichosz, SL, Jakobsen, PE, Yderstraede, K, Gulichsen, E, Nygaard, H, Eldrup, E, Lervang, HH, Tarnow, L, Ejskjaer, N
Journal of diabetes science and technology. 2015;(3):681-6
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OBJECTIVE The objective of this study was to elucidate whether the degree of autonomic modulation is associated with the degree of microvascular complications in patients with type 1 diabetes. METHODS A total of 290 type 1 individuals with diabetes were randomly recruited during normal visits to outpatient clinics at 4 Danish hospitals. The degree of autonomic modulations was quantified by measuring heart rate variability (HRV) during passive spectral analysis and active tests (valsalva ratio [VT], response to standing [RT], and deep breathing [E:I]). To describe possible associations between severity of microvascular complications and measures of autonomic modulation, multivariate analysis was performed. RESULTS After adjusting for diabetes duration, sex, age, pulse pressure, heart rate, and smoking, autonomic dysfunction remained significantly correlated with severity of retinopathy, nephropathy, and peripheral neuropathy in individuals with type 1 diabetes patients. CONCLUSIONS Autonomic dysfunction is present in early stages of retinopathy, nephropathy, and peripheral neuropathy in patients with type 1 diabetes.
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Stimulation of the autonomic nervous system in colorectal surgery: a study protocol for a randomized controlled trial.
Berghmans, TM, Hulsewé, KW, Buurman, WA, Luyer, MD
Trials. 2012;:93
Abstract
BACKGROUND Postoperative ileus (POI) is a well-known complication of abdominal surgery and is considered to be caused by a local inflammation in the gut. Previously it has been shown that both local and systemic inflammation can be reduced by stimulation of the autonomic nervous system via lipid rich nutrition. Stimulation of the autonomic nervous system releases acetylcholine from efferent vagal nerve endings that binds to nicotinic receptors located on the inflammatory cells leading to a decrease of pro-inflammatory mediators. Besides administration of nutrition there are other ways of stimulating the autonomic nervous system such as gum chewing. METHODS/DESIGN This prospective, placebo-controlled randomized trial will include 120 patients undergoing colorectal surgery which are randomized for gum chewing preoperatively and in the direct postoperative phase or a placebo. Postoperative ileus will be assessed both clinically by time to first flatus and time to first defecation and by determination of gastric motility using ultrasound to measure dimensions of the antrum. Furthermore the inflammatory response is quantified by analyzing pro-inflammatory mediators. Finally, markers of gut barrier integrity will be measured as well as occurrence of postoperative complications. DISCUSSION We hypothesize that chewing gum preoperatively and in the direct postoperative phase in patients undergoing colorectal surgery dampens local and systematic inflammation, via activation of the autonomic nervous system. Down-regulation of the inflammatory cascade via stimulation of the vagus nerve will ameleriote POI and enhance postoperative recovery. TRIAL REGISTRATION NTR2867.
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Prenatal stretching exercise and autonomic responses: preliminary data and a model for reducing preeclampsia.
Yeo, S
Journal of nursing scholarship : an official publication of Sigma Theta Tau International Honor Society of Nursing. 2010;(2):113-21
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PURPOSE Preeclampsia is a leading cause of perinatal mortality and morbidity, and it increases maternal risk for future cardiovascular disease. The purpose of the study was to explore the relationships among stretching exercise, autonomic cardiac response, and the development of preeclampsia. DESIGN Secondary data analysis. METHODS Heart rate and pulse pressure were longitudinally examined in this secondary data analysis among women who engaged in stretching exercise daily from 18 weeks of gestation to the end of pregnancy compared with women who did walking exercise daily during the same time period. A total of 124 women were randomized to either stretching (n=60) or walking (n=64) in the parent study. FINDINGS Heart rates in the stretching group were consistently lower than those in the walking group. CONCLUSIONS Based on the results of this secondary data analyses, a physiologic framework for possible beneficial effects of stretching exercise by enhancing autonomic responses on reducing risks for preeclampsia is proposed and discussed. CLINICAL RELEVANCE If the protective effect is established, stretching exercise can be translated into nursing intervention for prenatal care.
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Effects of prior intensive insulin therapy on cardiac autonomic nervous system function in type 1 diabetes mellitus: the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study (DCCT/EDIC).
Pop-Busui, R, Low, PA, Waberski, BH, Martin, CL, Albers, JW, Feldman, EL, Sommer, C, Cleary, PA, Lachin, JM, Herman, WH, et al
Circulation. 2009;(22):2886-93
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BACKGROUND The Epidemiology of Diabetes Interventions and Complications (EDIC) study, a prospective observational follow-up of the Diabetes Control and Complications Trial (DCCT) cohort, reported persistent benefit of prior intensive therapy on retinopathy and nephropathy in type 1 diabetes mellitus. We evaluated the effects of prior intensive insulin therapy on the prevalence and incidence of cardiac autonomic neuropathy (CAN) in former DCCT intensive and conventional therapy subjects 13 to 14 years after DCCT closeout. METHODS AND RESULTS DCCT autonomic measures (R-R variation with paced breathing, Valsalva ratio, postural blood pressure changes, and autonomic symptoms) were repeated in 1226 EDIC subjects in EDIC year 13/14. Logistic regression models were used to calculate the odds of incident CAN by DCCT treatment group after adjustment for DCCT baseline covariates, duration in the DCCT, and quantitative autonomic measures at DCCT closeout. In EDIC year 13/14, the prevalence of CAN using the DCCT composite definition was significantly lower in the former intensive group versus the former conventional group (28.9% versus 35.2%; P=0.018). Adjusted R-R variation was significantly greater in the former DCCT intensive versus the former conventional group (29.9 versus 25.9; P<0.001). Prior DCCT intensive therapy reduced the risks of incident CAN by 31% (odds ratio, 0.69; 95% confidence interval, 0.51 to 0.93) and of incident abnormal R-R variation by 30% (odds ratio, 0.70; 95% confidence interval, 0.51 to 0.96) in EDIC year 13/14. CONCLUSIONS Although CAN prevalence increased in both groups, the incidence was significantly lower in the former intensive group compared with the former conventional group. The benefits of former intensive therapy extend to measures of CAN up to 14 years after DCCT closeout.
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Comparative effects of amlodipine monotherapy and combination therapy with betaxolol on cardiac autonomic nervous activity and health-related quality of life in patients with poorly controlled hypertension.
Takase, B, Takeishi, Y, Hirai, T, Lee, JD, Uzui, H, Senda, S, Miwa, K, Hiraoka, Y, Kinugawa, T, Hosokawa, R, et al
Circulation journal : official journal of the Japanese Circulation Society. 2008;(5):764-9
Abstract
BACKGROUND The aim of the study was to evaluate whether the combined treatment of calcium channel blocker, amlodipine and beta-blocker, betaxolol, favorably affects cardiac autonomic nervous activity (CANA) and health-related quality of life (HRQL). METHODS AND RESULTS A total of 65 patients with a poor blood pressure (BP) control with a low dose amlodipine therapy were randomly assigned to the amlodipine dose-up group (n=21) and betaxolol adding group (n=44). Before and after a 6-month treatment, BP, heart rate variability (HRV), HRQL and blood chemistries were evaluated. Low frequency (LF) spectra/high frequency (HF) spectra and HF/total power spectra (TP) were calculated as indexes of CANA, and HRQL was assessed by the questionnaire sheets. BP was well controlled in all patients of the present study. In the betaxolol adding group, LF/HF decreased (2.1+/-1.9 to 1.3+/-0.9, p<0.05) and HF/TP reciprocally increased (0.41+/-0.17 to 0.52+/-0.18, p<0.05), whereas the amlodipine dose-up group showed no significant changes in the HRV. HRQL was significantly improved in the betaxolol adding group, whereas it remained unchanged in the amlodipine dose-up group. Blood chemistries remained unchanged except for the slightly increased plasma brain natriuretic peptide concentrations in the betaxolol adding group (36+/-47 to 62+/-62 pg/ml, p<0.05). CONCLUSIONS Combined treatment of amlodipine and betaxolol appears to be more useful than amlodipine dose-up therapy, because combined treatment improves CANA and HRQL.
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123 I-mIBG scintigraphy to predict inducibility of ventricular arrhythmias on cardiac electrophysiology testing: a prospective multicenter pilot study.
Bax, JJ, Kraft, O, Buxton, AE, Fjeld, JG, Parízek, P, Agostini, D, Knuuti, J, Flotats, A, Arrighi, J, Muxi, A, et al
Circulation. Cardiovascular imaging. 2008;(2):131-40
Abstract
BACKGROUND Disturbances of autonomic function after infarction are associated with both total mortality and sudden death. Although many imaging techniques for assessing the cardiac autonomic nervous system have been studied, the clinical usefulness of these techniques remains uncertain. This exploratory pilot study examined the relationship between abnormalities of ventricular sympathetic innervation delineated by scintigraphic imaging with (123)I-mIBG and inducible ventricular tachyarrhythmias in patients with left ventricular dysfunction and previous myocardial infarction. METHODS AND RESULTS Fifty patients underwent electrophysiological (EP) testing and 15-minute and 4-hour planar and single photon emission computed tomography (SPECT) imaging with (123)I-mIBG and SPECT imaging with (99m)Tc-tetrofosmin. The primary efficacy variables were the 4-hour heart:mediastinum ratio (H/M) and the (123)I-mIBG/(99m)Tc-tetrofosmin SPECT mismatch score. EP studies were categorized as positive (EP(+)) or negative (EP(-)) for inducibility of sustained (>30 seconds) ventricular tachyarrhythmias. Thirty patients were EP(+), and 20 were EP(-). There were no significant differences in the 4-hour H/M ratios or (123)I-mIBG/(99m)Tc-tetrofosmin SPECT mismatch scores between the two groups. In a multivariable analysis using all (123)I-mIBG and (99m)Tc-tetrofosmin SPECT measurements, the only variable that showed a significant difference between EP(+) and EP(-) patients was the 4-hour (123)I-mIBG SPECT defect score. A 4-hour (123)I-mIBG SPECT defect score of > or =37 yielded a sensitivity of 77% and specificity of 75% for predicting EP results. CONCLUSIONS The standard indices of (123)I-mIBG imaging (H/M and innervation-perfusion mismatch score) are not predictive of EP test results. The association of (123)I-mIBG SPECT defect severity with EP test inducibility in this exploratory study will require confirmation in a larger cohort of patients.