Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): multicentre randomised phase 3 clinical trial.

OBJECTIVE: To investigate whether monitoring of cerebral tissue oxygen saturation using near infrared spectroscopy in addition to routine monitoring combined with defined treatment guidelines during immediate transition and resuscitation increases survival without cerebral injury of premature infants compared with standard care alone. DESIGN: Multicentre, multinational, randomised controlled phase 3 trial. SETTING: 11 tertiary neonatal intensive care units in six countries in Europe and in Canada. PARTICIPANTS: 1121 pregnant women (<32 weeks' gestation) were screened prenatally. The primary outcome was analysed in 607 of 655 randomised preterm neonates: 304 neonates in the near infrared spectroscopy group and 303 in the control group. INTERVENTION: Preterm neonates were randomly assigned to either standard care (control group) or standard care plus monitoring of cerebral oxygen saturation with a dedicated treatment guideline (near infrared spectroscopy group) during immediate transition (first 15 minutes after birth) and resuscitation. MAIN OUTCOME MEASURE: The primary outcome, assessed using all cause mortality and serial cerebral ultrasonography, was a composite of survival without cerebral injury. Cerebral injury was defined as any intraventricular haemorrhage or cystic periventricular leukomalacia, or both, at term equivalent age or before discharge. RESULTS: Cerebral tissue oxygen saturation was similar in both groups. 252 (82.9%) out of 304 neonates (median gestational age 28.9 (interquartile range 26.9-30.6) weeks) in the near infrared spectroscopy group survived without cerebral injury compared with 238 (78.5%) out of 303 neonates (28.6 (26.6-30.6) weeks) in the control group (relative risk 1.06, 95% confidence interval 0.98 to 1.14). 28 neonates died (near infrared spectroscopy group 12 (4.0%) v control group 16 (5.3%): relative risk 0.75 (0.33 to 1.70). CONCLUSION: Monitoring of cerebral tissue oxygen saturation in combination with dedicated interventions in preterm neonates (<32 weeks' gestation) during immediate transition and resuscitation after birth did not result in substantially higher survival without cerebral injury compared with standard care alone. Survival without cerebral injury increased by 4.3% but was not statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov NCT03166722.

Cerebral oxygenation and bioelectrical activity in preterm infants during surfactant replacement therapy with porcine and bovine preparations.

Introduction: Surfactant replacement therapy (SRT) might cause acute changes in cerebral oxygenation and alteration of brain bioelectrical activity. Varying physiologic responses and clinical outcomes were observed when different surfactant preparations were instilled to treat neonatal respiratory distress syndrome (RDS). Material and methods: Neonates born at 26-30 weeks of gestation with RDS requiring intubation and mechanical ventilation were randomized to SRT either with poractant alfa (A) or beractant (B). Saturation (SpO2), heart rate (HR), cerebral tissue oxygenation (StO2) and amplitude-integrated electroencephalography (aEEG) were simultaneously recorded prior to and up to 4 h after SRT. Results: Mean SpO2, HR and StO2 values were comparable between groups at baseline and after SRT. There were differences in mean aEEG voltage before SRT, but amplitudes were within a range considered as normal in both groups. Immediately after SRT and at a few single post-intervention time points mean aEEG voltage was higher in the beractant group. There was a significant difference in the percentage of time with the aEEG signal < 5 µV after SRT between groups (mean 25.7% (A) vs. 16.5% (B), p < 0.05). Quantity of bursts per minute and mean length of inter-burst intervals (IBI) in the aEEG recording varied insignificantly but there was a significant difference in the percentage of IBI > 30 s between groups (52.5% (A) vs. 36.6% (B), p <0.05). Conclusions: This is the first study assessing brain bioelectrical function and oxygenation while using two different surfactant preparations in a neonate. Cerebral effects of SRT are observed regardless of the type of surfactant, but their magnitude may depend on the preparation and/or dosing used.

Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth (COSGOD III): an investigator-initiated, randomized, multi-center, multi-national, clinical trial on additional cerebral tissue oxygen saturation monitoring combined with defined treatment guidelines versus standard monitoring and treatment as usual in premature infants during immediate transition: study protocol for a randomized controlled trial.

BACKGROUND: Transition immediately after birth is a complex physiological process. The neonate has to establish sufficient ventilation to ensure significant changes from intra-uterine to extra-uterine circulation. If hypoxia or bradycardia or both occur, as commonly happens during immediate transition in preterm neonates, cerebral hypoxia-ischemia may cause perinatal brain injury. The primary objective of the COSGOD phase III trial is to investigate whether it is possible to increase survival without cerebral injury in preterm neonates of less than 32 weeks of gestation by targeting cerebral tissue oxygen saturation (crSO2) using specified clinical treatment guidelines during the immediate transition period after birth (the first 15 min) in addition to the routine monitoring of arterial oxygen saturation (SpO2) and heart rate (HR). METHODS/DESIGN: COSGOD III is an investigator-initiated, randomized, multi-center, multi-national, phase III clinical trial. Inclusion criteria are neonates of less than 32 weeks of gestation, decision to provide full life support, and parental informed consent. Exclusion criteria are severe congenital malformations of brain, heart, lung, or prenatal cerebral injury or a combination of these. The premature infants will be randomly assigned to study or control groups. Both groups will have a near-infrared spectroscopy (NIRS) device (left frontal), pulse oximeter (right palm/wrist), and electrocardiogram placed immediately after birth. In the study group, the crSO2, SpO2, and HR readings are visible, and the infant will receive treatment in accordance with defined treatment guidelines. In the control group, only SpO2 and HR will be visible, and the infant will receive routine treatment. The intervention period will last for the first 15 min after birth during the immediate transition period and resuscitation. Thereafter, each neonate will be followed up for primary outcome to term date or discharge. The primary outcome is mortality or cerebral injury (or both) defined as any intra-ventricular bleeding or cystic periventricular leukomalacia (or both). Secondary outcomes are neonatal morbidities. DISCUSSION: crSO2 monitoring during immediate transition has been proven to be feasible and improve cerebral oxygenation during immediate transition. The additional monitoring of crSO2 with dedicated interventions may improve outcome of preterm neonates as evidenced by increased survival without cerebral injury. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03166722 . Registered March 5, 2017.

Sexual health of male cardiac patients - present status and expectations of patients with coronary heart disease.

INTRODUCTION: Due to the pathogenetic association between erectile disorders and cardiovascular diseases, cardiologists consult many patients with erectile dysfunction (ED). The aim of the study was to evaluate sexual function in patients with coronary heart disease (CHD) and the use of sexual knowledge in cardiology practice, both current use and that expected by patients. MATERIAL AND METHODS: One thousand one hundred and thirty-six patients (average age: 60.73 ±9.20) underwent a dedicated survey which encompassed demographic data and the presence of modifiable ED risk factors. The presence of ED was assessed using the International Index of Erectile Function (IIEF-5) Questionnaire. RESULTS: Sexual problems were discussed by cardiologists with 45 (3.96%) patients. The frequency of initiating the topic was significantly associated with the respondents' education level (p = 0.0031); however, it was not associated with the patients' age, duration of CHD, presence of ED, or modifiable risk factors. Four hundred and sixteen (36.62%) respondents indicated that they expect their cardiologist to take an interest in their ED. Nine hundred and twenty-six (81.51%) patients claimed good sexual function to be important or very important to them. Attitude to sexual function was significantly associated with age (p < 0.0001), duration of CHD (p = 0.0018), education (p = 0.0011), presence of ED (p = 0.0041), diabetes (p = 0.0283) and hyperlipidaemia (p = 0.0014). CONCLUSIONS: The low frequency with which cardiologists initiate the topic of ED is in contrast to the expectations of patients with CHD. The majority of these patients regard good sexual maintenance as an important part of their life.

Heart rate recovery, cardiac rehabilitation and erectile dysfunction in males with ischaemic heart disease.

OBJECTIVE: Heart rate recovery (HRR) is a recognised marker used in clinical practice for assessing the risk of sudden cardiac death. Physical exercise leads to an improvement in HRR and has a proven beneficial effect on erection quality (EQ) related to the activity of the autonomic nervous system in men with ischaemic heart disease (IHD). This paper evaluates the relationship between HRR and EQ in patients with IHD and erectile dysfunction (ED) who underwent cardiac rehabilitation. METHODS: The main analysis was based on the Mann-Whitney U test, Wilcoxon signed-rank test, Spearman correlation coefficient, Pearson's chi-square test, chi-square test, with the Yates correction and (if possible) parametric tests were used. This prospective, non-randomised intervention study included 124 men with IHD and ED [International Index of Erectile Function (IIEF-5) scores of ≤21]. Of these, 89 patients underwent a 6-month cardiac rehabilitation phase III programme, whereas 35 did not. The results of the participants' total IIEF-5 scores and their HRR, demographic and clinical data were analysed. RESULTS: The results of the 89 rehabilitated patients (mean age: 60.44±9.29 years) and 35 controls (mean age: 61.43±8.81 years) were analysed. In the rehabilitated patients, the mean baseline IIEF-5 score was 13.15±5.76 (95% CI: 11.93-14.36) and HRR was 16.49±7.68/min (95% CI: 14.88-18.11). After cardiac rehabilitation, the parameters of ED and HRR improved significantly and were significantly higher than those of the controls; the mean IIEF-5 score of the rehabilitated group increased to 15.36±6.51 (95% CI: 13.99-16.73), while HRR increased to 21.40±7.25/min (95% CI: 19.88-22.93). A significant correlation was found between ∆HRR and ∆EQ (r=0.409791) as a result of the 6-month cardiac training programme. CONCLUSION: Cardiac rehabilitation assessed by HRR has a sizable effect on autonomic balance in patients with IHD and ED, which plays a significant role in the mechanism of erection improvement.

Comparison of cerebral tissue oxygenation values in full term and preterm newborns by the simultaneous use of two near-infrared spectroscopy devices: an absolute and a relative trending oximeter.

The aim of this study is to compare a two-wavelength light emitting diode-based tissue oximeter (INVOS), which is designed to show trends in tissue oxygenation, with a four-wavelength laser-based oximeter (FORE-SIGHT), designed to deliver absolute values of tissue oxygenation. Simultaneous values of cerebral tissue oxygenation (StO2) are measured using both devices in 15 term and 15 preterm clinically stable newborns on the first and third day of life. Values are recorded simultaneously in two periods between which oximeter sensor positions are switched to the contralateral side. Agreement between StO2 values before and after the change of sensor position is analyzed. We find that mean cerebral StO2 values are similar between devices for term and preterm babies, but INVOS shows StO2 values spread over a wider range, with wider standard deviations than shown by the FORE-SIGHT. There is relatively good agreement with a bias up to 3.5% and limits of agreement up to 11.8%. Measurements from each side of the forehead show better repeatability for the FORE-SIGHT monitor. We conclude that performance of the two devices is probably acceptable for clinical purposes. Both performed sufficiently well, but the use of FORE-SIGHT may be associated with tighter range and better repeatability of data.

Serum levels of interleukin-6, interleukin-10 and C-reactive protein in patients with myocardial infarction treated with primary angioplasty during a 6-month follow-up.

INTRODUCTION: Recent studies indicate that inflammatory and immune factors are involved in the post-infarction cardiac remodeling. OBJECTIVES: We evaluated serum levels of interleukin-6 (IL-6), interleukin-10 (IL-10) and C-reactive protein (CRP) in patients with acute coronary syndrome with ST-segment elevation myocardial infarction (STEMI) in the acute phase of the disease and 6 months later. Moreover we sought to determine the effect of selected clinical parameters on the levels of the inflammatory factors. PATIENTS AND METHODS: The study involved 75 patients with STEMI, aged 36-82 years, treated with primary angioplasty. Blood samples for determination of IL-6, IL-10 and CRP levels were taken on the 3rd and 7th day of hospitalization and after 6 months. RESULTS: In the acute phase of myocardial infarction (MI) the levels of IL-6, IL-10 and CRP, as well as the IL-6/IL-10 and CRP/IL-10 indexes were higher than in the control group. Six months later the CRP level decreased significantly, and the levels of IL-6 and IL-10 and the studied indices normalized. In the acute phase of MI there were positive correlations between the studied factors. The independent predictors of IL-6, IL-10 and CRP levels were body mass index (BMI), troponin I, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and the baseline levels of inflammatory markers. CONCLUSIONS: In the acute phase of MI, inflammatory activation is enhanced with predominant proinflammatory response. In the course of the healing process within 6 months inflammation is suppressed and the balance between pro- and anti-inflammatory activation is restored. The size of MI, BMI, lipid levels and the baseline levels of inflammatory markers influence the levels of inflammatory factors.

[Postinfarction cardiac remodeling--clinical consequences]. / Pozawalowa przebudowa serca--konsekwencje kliniczne.

Despite the considerable progress in the setting of invasive and pharmacological treatment still in about 20-30% patients with myocardial infarction in long-term observation an unfavourable post-infarction remodeling along with development of LV dilatation is to be seen. The heart forms the structural and functional unity, thus morphological changes due to cardiac post-infarction remodeling process are accompanied by systolic and diastolic myocardial dysfunction, which in consequence may lead to appearance of heart failure. In recent years our knowledge regarding causative factors of post-infarction cardiac remodeling has been remarkably widening and in the light of accumulating data indicating the possibility of LV remodeling regression, elaboration of the new specific-orientated methods of counteracting its uneventful consequenses is a matter of time.

Serum levels of interleukin-6, interleukin-10 and C-reactive protein in relation to left ventricular function in patients with myocardial infarction treated with primary angioplasty.

BACKGROUND: Inflammatory factors are involved in the cardiac remodelling process after myocardial infarction (MI). Pronounced and sustained activation of proinflammatory factors is believed to enhance the damage to the myocardium and leads to its dysfunction and heart failure. Anti-inflammatory factors, especially interleukin-10 (IL-10), exert a protective action by reducing excessive inflammatory reactions. AIM: To asses the relationship between serum levels of IL-6, IL-10, CRP and echocardiographic indices of myocardial function in patients with ST-elevated myocardial infarction (STEMI) treated with primary angioplasty. Prognostic value of IL-6, IL-10 and CRP levels in predicting systolic and diastolic dysfunction 6 months after MI was also assessed. METHODS: We studied 75 patients aged 36-82 (28 women and 47 men) presenting with STEMI treated with primary angioplasty. Blood samples for assesment of IL-6, IL-10 and CRP levels were on days 3 and 7 (3d, 7d) of MI and after 6-month follow-up (6m). Echocardiographic examination was performed on day 7 and 6 months after MI during which the parameters of LV systolic (LVEF, WMSI) and diastolic function (E/A, DT, IVRT, Ep, E/Ep) were evaluated. Twenty four healthy persons served as controls. RESULTS: Interleukin-6 and CRP levels in consecutive measurements correlated significantly inversely with LVEF (7d) and LVEF (6m). The IL-10 (7d) and IL-10 (6m) level correlated positively with LVEF (6m) (r=0.39, p=0.02; r=0.27, p=0.04). The IL-6 and CRP levels in consecutive measurements correlated significantly positively with E/A and E/Ep and inversely with IVRT, DT and Ep. The IL-10 (3d) level correlated inversely with DT (6m) (r=-0.25, p=0.04), while IL-10 (7d) level correlated positively with DT (6m) (r=0.36, p=0.004). Increased level of IL-6 (3d) and CRP (3d) was an independent prognostic factor of LV systolic (OR=1.27, p=0.02; OR=1.14, p=0.05) and diastolic dysfunction (OR=1.14, p=0.03; OR=1.05, p=0.01) 6 months after MI. CONCLUSIONS: 1. A significant, correlations between increased IL-6, CRP level and impaired LV systolic and diastolic function indicate the possible involvement of these factors in postinfarction cardiac damage. 2. Increased level of IL-6 and CRP in the acute phase of MI is an independent predictor of LV systolic and diastolic dysfunction 6 months after MI. 3. Increased serum level of IL-10 in the acute phase of MI reflects the extension of post-infarction myocardial lesion. 4. Maintenance of increased level of IL-10 for days/months after MI seems to be prognostically beneficial.