Irrua, Nigeria

Fluid Status and T1-mapping by CMR

Atrial Fibrillation at the Viennese University Emergency Department

Atrial fibrillation is the most common cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality, with stroke being an especially important and potentially devastating complication. The number of patients with atrial fibrillation is likely to increase 2.5-fold during the next 50 years, reflecting the growing proportion of elderly individuals. Emergency departments play a central role in diagnosis and treatment (rhythm and rate control, initiation of anticoagulatory therapy for stroke prevention) of atrial fibrillation. Additionally, embolic (e.g. stroke, mesenteric ischemia) complications of atrial fibrillation and bleeding complications (e.g. gastrointestinal and intracranial) of anticoagulatory therapy are likewise treated at emergency departments. Therefor the investigators hypothesis implies that the atrial fibrillation registry could serve as a tool for structured diagnosis and therapy in patients with atrial fibrillation and therefore may improve patient care. Additionally, diagnostic and therapeutic shortcomings by analyzing registry data may be detected.

Add-on Cangrelor in STEMI-triggered Cardiac Arrest

Neurologic damage after cardiac arrest is frequent and therapeutic options to improve neurological outcome are limited. Treatment by therapeutic hypothermia (TH, 32-34◦C) for 12-24 h showed improved neurological outcome in several trials. Therefore, international guidelines recommend targeted temperature management (TTM) to 32-34◦C (or at least 36°C) for 12-24 h, especially when the initial rhythm was ventricular fibrillation. However, patients treated with TTM after cardiac arrest show deteriorated and delayed response to P2Y12 receptor (P2Y12r) inhibitors as determined by platelet reactivity index vasodilator-stimulated phosphoprotein phosphorylation (PRI VASP) after administration of the loading dose of clopidogrel, prasugrel and ticagrelor. Especially the response to clopidogrel is poor with up to >80% non-responder after 24 hours. Impaired P2Y12r blockade may lead to acute stent-thrombosis and trigger overall adverse outcome. There are several explanations for the impaired efficacy of P2Y12r inhibitors in cardiac arrest patients. First, marketed oral P2Y12r inhibitors have to be applied in crushed form via nasogastric tube in comatose post cardiac arrest patients. Placement of nasogastric tube and crushing may delay onset of therapy. Second, drug uptake and bioavailability of oral P2Y12r inhibitors are dependent on gastric motility and sufficient splanchnic blood supply, which is affected by TTM, acute critical illness (shock) and concomitant therapy. Particularly, sedation and analgesic agents, especially concomitant morphine therapy, can hamper gastric emptying. Various recent trials demonstrated that morphine administration delays and attenuates clopidogrel, prasugrel and ticagrelor exposure and action in healthy subjects and patients with myocardial infarction. The recently authorized parenteral cangrelor is an adenosine triphosphate (ATP) analogue that binds reversibly and with high affinity to the platelet P2Y12r. It induces a highly effective inhibition of ADP-induced platelet aggregation immediately after intravenous (iv) bolus administration and allows for restoration of platelet function within 1-2 h of infusion discontinuation. The pharmacokinetic properties known so far suggest cangrelor being the "ideal" P2Y12r inhibitor for patients with cardiac-ischemia triggered OHCA treated with TH and may overcome the impaired and delayed P2Y12r blockade seen with the oral P2Y12r inhibitors. Cardiac arrest is a leading cause of death among adults over the age of 40 in the European Union (EU) and other western countries. In the EU alone, more than 400.000 people of all ages experience EMS-assessed out-of-hospital non-traumatic cardiac arrest each year and most of them die. In a large proportion of these patients (about 50%) an acute coronary syndrome (ACS), mainly acute ST-elevation myocardial infarction, leading to ventricular fibrillation and cardiac standstill is the cause of the cardiac arrest. Various trials demonstrated that early cardiac intervention including stent placement to the culprit lesion improves outcome in this patient group. The P2Y12r plays a central role in platelet activation and P2Y12r inhibitors are part of standard care in patients with ACS. Delayed and insufficient P2Y12r inhibition may predispose to acute stent thrombosis with potential devastating effects including cardiogenic shock, re-arrest and death. Given the deteriorated and delayed response to oral P2Y12r inhibitors in cardiac arrest patients treated with TH, clinical evaluation of the recently marketed parenteral P2Y12r inhibitor cangrelor is mandatory in this patient group. To determine the effect of add-on cangrelor in STEMI-associated out-of-hospital cardiac arrest (OHCA) who receive TTM and are scheduled for PCI, a phase 4 trial will be conducted.The trial consists of 2 parts. Part A (n=12, 8months duration): An open-fashioned pilot safety-study to ensure sufficient platelet suppression (<466AU*min, impedance aggregometry) over 24 hours after concurrent cangrelor-prasugrel/ticagrelor administration. The aim is to determine pharmacokinetics and -dynamics of oral P2Y12r-inhibitors with and without concomitant administration of cangrelor. Part B (n=48, 32months duration): A factorial randomized, placebo-controlled, double-blind study with 4 study cohorts enrolling 48 patients who will first be randomised to receive prasugrel (n=24) or ticagrelor (n=24) and secondly to additionally receive cangrelor or placebo (sterile saline). Primary endpoint: ADP-dependent platelet reactivity at time of stent placement (AU*min). Student's t-test to test H0 (no difference in AU*min, cangrelor vs placebo).

Skin Incision Skewness at Cesarean Section

Some aspects of the surgical techniques employed during cesarean section have already been evaluated in regards to possible improvements of cosmetic outcome, such as the use of different skin closure materials or whether subcutaneous fat suture closure leads to better results than non-closure. Another point to be considered is the skewness of the scar. Many surgeons make the skin incision based on their experience without prior measurement and drawing of an incision line. However, following a predefined incision line may reduce the rate of skew incisions. Therefore, this study aims to compare these two approaches to the skin incision. Participating women will be recruited at the Department of Obstetrics and Gynecology of the Medical University of Vienna. They will be included into the study after written informed consent and will be randomized into one of the two groups (drawing of an incision line prior to skin incision versus no drawing of an incision line) on the day of cesarean section. Skewness of the skin incision in each group will be assessed after cesarean section. Furthermore, it will be determined whether there are any differences in the incision length on both sides of an imaginary line from the umbilicus to the clitoris between these two techniques. Additionally, patient's perception of the scar before discharge from hospital will be assessed.

High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study

Computerized Registry of Patients With Venous Thromboembolism (RIETE)

The RIETE Registry pretends the improvement of care of patients with thromboembolic disease. Very often the investigators pose serious doubts on how to manage a specific patient. Sometimes because it is a patient with thrombocytopenia, a pregnant woman, a patient with a recent cerebral bleeding or cerebral metastasis, a patient with gastroduodenal ulcer or hepatic cirrhosis. There is no clinical evidence about how the investigators should manage these patients and the investigators have to individualize its management. The bibliography available is not of much help. Only if the investigators have a database with a sufficient number of cases, they may be able to make evidence based decisions. This database on the Internet will allow the investigators to consult and obtain an immediate response when taking care of a patient who needs an individualized management. After introducing the patient the investigators will automatically obtain the data of all patients with similar clinical profiles. And this will help the investigators to identify high-risk patients and thus facilitate them preventing possible future complications.

NutritionDay in Worldwide Hospitals: An International Audit and Registry on Nutrition and Outcome

One day international cross-sectional audit in all types of hospital wards. Intensive care units are excluded. Data are collected with the help of questionnaires. Anonymised data entry into the audit database is done with individual and anonymous center and unit-codes. The data collected consist of four parts: 1. Unit organisation and structures: Structural information about the unit (one sheet / unit) to be filled by the unit supervising physician together with the nursing head. 2. Patient's demographics & medical information: Demographic profile, diagnostic category based on ICD 10 and nutritional interventions for all patients (one line / patient) to be filled by a responsible person from the medical staff. Oncological patients have an additional caregiver sheet to define precisely cancer stage and specific treatment. 3. Individual self-administered patient questionnaire: Each patient should document her/his nutritional intake during the study period. In addition patients may be asked to fill a questionnaire about changes in nutritional habits and reasons for decreased nutritional intake from the patient's perspective. Oncological patients have an additional optional patient sheet to determine the specific nutritional problems and supportive treatments used. 4. Individual patient outcome: hospital cohort: at hospital discharge or day 30, whatever comes first: date of unit discharge, date of hospital discharge, site of discharge and health status. Participation rules: 1. A user needs to register to nutritionDay as a member to the nutritionDay network. Each may choose a personal user name. Each user needs to provide a valid email address. After responding to a validation email the user is registered with the chosen user name. User details are stored on a system that is not connected to the nutritionDay registry at any time. One user may serve as contact for several units and centers. 2. A user may order codes for participation for one or several centers and units. Access to the registry is only possible with a center code and unit code. These codes are selected from a list of random numbers. Audit/registry recruitment plan: Participation to the registry is voluntary. There is actually no participation fee. All necessary information can be obtained from a dedicated website (www.nutritionday.org). Participation can be promoted via international and national scientific societies, universities, health care organisations or governmental agencies as well as via advertisement at international and national congresses. The target would be all types of hospital wards within hospitals of different sizes and level of care. Risk and benefit assessment: The benefit for each patient is that awareness and knowledge about nutrition related factors and treatment options in the treating unit is increased. There is no individual risk since the audit is purely observational. The benefit for the individual unit is to receive an extensive benchmarking report displaying the unit data in comparison with all units from the same specialty from the previous 3 years immediately after the end of data entry and a validation step. Units or groups of units may request specific reports that can be obtained only after a case by case agreement and financial coverage. All data used as a reference for benchmarking purpose are from units where a minimum of 60% of actually present patients have been recruited and the outcome at day 30 is available in more than 80% of these patients. There is no risk for the unit since anonymity of unit is structurally strictly maintained. The benefit for the registry up-to-date data enabling benchmarking in pace with medical and care evolution. Moreover the registry data are used for research of the scientific community. The aim is to recruit a minimum of 10-50 units with 20-30 beds per participating country. A minimum of 10 units per medical specialty will be necessary to allow specialty adjustment. Data security: On the datasheets the unit and the hospital/center are identified by a numeric code delivered after application to the nutritionDay coordinating center by an automatic system. The only requirement is a valid email address for direct communication with the unit. Patients are usually identified on the locally used questionnaires by initials and age, but use of initials is not mandatory. Consecutive numbering is also possible. Only the participating unit has to trace patients identifier to be able to collect hospital outcome at day 30 after nutritionDay and to answer automatic requests for data clarification during the data quality feedback. During data entry into the electronic registry only anonymous codes for center, unit and patients are possible. Thus the data handling centre cannot trace data back to an individual patient. The access to data entry is protected by anonymous center-code and unit-code. Typically all data are collected via a dedicated website accessed via www.nutritionday.org . The protected data server is run by the Center for Medical Statistics Informatics and Intelligent Systems (CEMSIS) of the Medical University Vienna. The data server is mirrored and backed up. The data server is protected within the University Firewall against external access. Data feedback and individual unit report All participating units are entitled to receive a bench-marking report from the registry. The report generator is started by the participating unit, when data entry has been completed. As a first step each unit receives a data feedback sheet that is based on an electronic data plausibility and missing data analysis. After stating that all data are correctly entered the final report can be generated. This final report offers complete descriptive statistics of the unit data compared to the reference data from the previous 4 years of the corresponding specialty. Only data from units fulfilling a high data quality standard are used for the reference. More than 60% of the patients present in the unit need to participate and 80% of these patients need to have their outcome recorded. Optionally the period used for comparison can be extended until 2006. All descriptive statistics represent prevalent data and are not corrected for cross-sectional sampling to allow direct data control and interpretation. All downloaded reports of a unit are consecutively numbered and stored for documentation purpose. Data analysis and modelling: The first aim of the project is to serve local specialty specific and up-to-date benchmarking with regard nutrition and feeding status , risk profile and nutrition care. Given the typical cross-sectional sample of 20-30 patients frequent risk factors can be easily compared because such risk factors as recent weight loss or less than normal eating are observed in one third to half of the patients. The second aim is scientific data analysis. The actual research questions are: - Identifying the risk factors associated with decreased eating. - Analysing the impact of risk factors for increased length of hospital stay - Analysing time-trends in risk profile and nutrition care - Analysing the economic impact of nutrition risk factors on the health care system - Updating the PANDORA score if major change in performance is identified The actual database includes 103 920 patients for the period 2006-2012 and allow the following precision for estimating the prevalence of risk factors: Risk factor prevalence 1% precision as 95% CI 0.93-1.07% Risk factor prevalence 5% precision as 95% CI 4.87-5.14% Risk factor prevalence 10% precision as 95% CI 9.81-10.19% Risk factor prevalence 20% precision as 95% CI 19.75-20.25% Risk factor prevalence 30% precision as 95% CI 29.72-30.29% Risk factor prevalence 40% precision as 95% CI 39.70-40.30% Given the typical participation of 12 000-20 000 patients annually, the investigators expect to have a sufficiently precise database for benchmarking, when using the last 4 years data. For the scientific data analysis the investigators use COX-regression or general linear model with proper weighting of observations to account for the effect of cross-sectional sampling for events such as discharge or death and linear regression models to analyse length of stay. Whenever several events can occur in a patient a competing risk analysis is performed. All data analysis will be done at the Dept. for Medical Statistics, Medical University Vienna. After publication of the multinational results, all national datasets will be available for national publication based on a research plan, if the number of wards is large enough to ensure anonymity for the individual ward within the country.

Non-invasive Optical Angiography in Age-related Macular Degeneration

Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs

This study will evaluate local pediatric intensive care unit (PICU), cardiac intensive care unit (CICU) and neonatal intensive care unit (NICU) as well as EDs and delivery room (DR) practice, and benchmark against other PICUs, CICUs, NICUs, DRs and EDs as a part of Multi-Center Airway Safety collaborative network (NEAR4KIDS). The goal of the study is to utilize collected benchmarked data to improve local practice. In order to develop this quality improvement (QI) intervention and collaboration, it is necessary to collect baseline data to describe current practice and to continuously evaluate the effectiveness of any QI intervention.

VICIS - Vienna Cirrhosis Study

Patients with advanced chronic liver disease (ACLD) as evident by HVPG>5mmHg or liver biopsy showing F3/F4 fibrosis or as suggested by liver stiffness measurement (LSM) ≥10kPa can be included in the VICIS study. In fact most patients will be recruited on the day of HVPG measurement for screening for clinically significant portal hypertension (CSPH) or on the day of upper GI endoscopy for screening for the presence of varices. Next to the detailled characterization of patient characteristics by epidemiologic, clinical and laboratory parameters, the degree of portal hypertension will be assessed by HVPG, liver stiffness will be assessed by transient elastography, the presence of ascites, splenomegaly, portosystemic collaterals, PVT and liver lesions will be assessed by ultrasound. In addition, the included patients will be asked to participate in biobank sampling including serum/plasma, ascitic fluid, urine, GI tract mucosal biopsies, stool, liver biopsies and stool. All patients recruited in the VICIS study will be prospectively followed every 3 months (decompenated ACLD) or every 6 months (compensated ACLD) patients with clinical visits at the Cirrhosis Outpatient Clinic at the Vienna General Hospital. These assessments include the recording of decompensating events (such as ascites, hepatic encephalopathy, variceal bleeding), screening for PVT and HCC, and recording of medications.