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NCT ID: NCT03922191 Recruiting - Mediastinitis Clinical Trials

Post-Surgical Mediastinitis Within the CHU Brugmann Hospital

Start date: February 12, 2019
Phase:
Study type: Observational

Mediastinitis is an infectious complication that can occur after cardiac surgery. The incidence varies between 1 and 3% depending on the type of procedure and the patient's condition. The mortality of this severe postoperative complication rises from 10 to 35%, which makes it dreadful. The major risk factors reported are obesity, diabetes, and immunosuppressive therapy. There are other less important ones: age, coronary bypass grafting (especially if using the two internal mammary arteries), nosocomial pneumonia, dialysis, prolonged mechanical ventilation, long operative asepsis, undrained retro-sternally hematoma, prolonged pre-operative hospitalization...). Prevention is very important. The principle of asepsis must absolutely be respected. The use of prophylactic antibiotic therapy is recommended. The most commonly encountered organisms are Staphylococcus aureus, coagulase-negative Staphylococci and gram-negative bacilli. There are several treatment modalities that vary between centers and may be different depending on the surgical team's experience and the depth or extent of the infection. The common principles of these treatments are: antibiotic therapy and surgical debridement (the timing of which may vary). The timing and modalities of wound closure are subject to variations: immediate sternal closure with placement of multiple or delayed drains. Muscle flaps or large omentum transplant may be necessary if tissue loss is too important. The investigators propose to review their experience in the treatment of cardiac post-surgery mediastinitis at Brugmann University Hospital in the last 20 years in both adult and pediatric patients.

NCT ID: NCT03922178 Recruiting - Coronary Surgery Clinical Trials

Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation

Start date: November 13, 2018
Phase: N/A
Study type: Interventional

The interpretation of perioperative measures of cardiac function during cardiac surgery is complicated. In particular, the evaluation of the diastolic compliance of the left ventricle. In addition, they are subject to variations induced by post-charge changes caused by the anesthesia, extracorporeal circulation (ECC) and the surgical procedure itself. Left ventricular failure is frequently measured by alteration of LV contractile properties, and very rarely by alteration of LV compliance. However, both contractility (systolic) and relaxation (diastolic) parameters are important for the left ventricle to perform its function adequately. Left ventricular failure after cardiac surgery with extracorporeal circulation and cardiac arrest under cardioplegia protection is an important and frequently reported complication. The investigator's objectives are to characterize the diastolic hemodynamic mechanisms of this left ventricular failure and to identify predictors of this failure in the postoperative period. The quantification of the systolic and diastolic functions of the left ventricle by ventricular pressure-volume curves is the technique of reference today, because it allows to determine parameters that are independent of the pre- and post-load conditions. Previous studies using the conductance catheter for the purpose of estimating left ventricular function perioperatively are rare and report conflicting results. In addition, they were mainly intended to measure the systolic function of the left ventricle. Only one reported the diastolic relaxation parameters evaluated by a conductance catheter. This study showed immediately after withdrawal of the extracorporeal circulation a significant alteration of the diastolic relaxation of the left ventricle, but was not interested in its early (kinetic) evolution peroperatively. The investigator's experience shows that, in the quarter-hour following the weaning of the extracorporeal circulation, a decrease in filling pressures of the left ventricle concomitant with an increase in cardiac output is objectified. These observations are consistent with a significant improvement in left ventricle compliance, but have never been reported. The objectives of this study are: - To characterize the left ventricular diastolic failure after withdrawal of the extracorporeal circulation in coronary surgery. - To identify the kinetics of this early diastolic failure after withdrawal of the extracorporeal circulation.

NCT ID: NCT03920800 Recruiting - Clinical trials for High-Grade Squamous Intraepithelial Lesions

Preventing Invasive Cervical Cancer: The Importance of Expectant Management in Young Women With High-grade Pre-cancerous Lesions

Start date: March 1, 2019
Phase:
Study type: Observational

Lesions classified as "High Grade Squamous Intra-epithelial Lesions" (HSIL) are pre-cervical lesions of the cervix, induced by infection with the Human Papilloma Virus (HPV). The detection and proper management of these lesions greatly reduces the incidence of invasive cervical cancer. Pap smear remains the most effective tool for early detection of low and high-grade cervical lesions. In Belgium, screening for cervical cancer is recommended every 3 years for women between 25 and 65 years old. HPV is a virus who possesses certain oncogenic genes who have the ability to inactivate tumor suppressor genes in the host cell. This promotes a tumorigenesis process within the tissues affected by the virus. The majority of human papillomavirus infections are transient and spontaneously cleared by host defense mechanisms, especially in the first two years after exposure. However, 10-20% of infections persist latently and may eventually lead to progression to invasive cervical cancer. Even high-grade lesions kan naturally be cleared, even more so if the patient is young and immuno-competent. Therefore, the management of HSIL lesions in young women has been modified and consists of adopting mainly a conservative attitude, with controls every 6 months for 2 years. This management makes it possible to avoid unnecessary conizations of the cervix which, in young nulliparous patients, are not devoid of heavy obstetric consequences during subsequent pregnancies (premature birth, perinatal mortality). Cervical conization will only be considered for lesions that progress during follow-up or that persist beyond 2 years. However, this type of follow-up requires that patients be compliant. Our study has two main objectives: - to determine the compliance of CHU Brugmann Hospital patients who have been proposed a conservative strategy for the management of HSIL lesions. - to identify the predictive factors for the persistence and / or progression of high-grade pre-cancerous dysplastic lesions.

NCT ID: NCT03919097 Recruiting - Flutter Clinical Trials

Identification of Risk Factors for Atrial Fibrillation After Ablation of an Atrial Flutter by Radiofrequency of the Cavotricuspid Isthmus.

Start date: January 8, 2019
Phase:
Study type: Observational

Atrial flutter is a common condition that is effectively treated by ablation using radiofrequency. Due to its feasibility, effectiveness and low procedural risk, radiofrequency ablation is a first-line treatment of atrial flutter. Several studies have been published concerning the factors associated with the occurrence of atrial fibrillation during or after flutter ablation, in patients with and without clinical history of atrial fibrillation. 26 to 46% of patients are likely to develop it, according to ECG or Holter diagnoses. The figure rises to more than 50% with a diagnosis with an implantable loop recorder. In patients without a prior history of atrial fibrillation before ablation, anticoagulants are routinely administered 4-6 weeks after flutter removal by most cardiologists. Although there are no specific guidelines for anticoagulation after flutter ablation, it is currently recommended to treat the patient as for atrial fibrillation. It is therefore crucial to identify in advance patients at high risk of atrial fibrillation after flutter ablation, in order to assess the appropriateness of maintaining oral anticoagulant therapy. The objectives of this study are: - to evaluate the frequency and identify the factors predicting the occurrence of atrial fibrillation after flutter ablation - to determine the risk of a stroke occurring in patients with atrial fibrillation after flutter ablation. The database consists in patients of the CHU Brugmann Hospital treated between 1996 and 2018.

NCT ID: NCT03919058 Recruiting - Multiple Sclerosis Clinical Trials

Sit Less or Exercise More: Impact on Cardiometabolic Health in MS

Start date: April 13, 2019
Phase: N/A
Study type: Interventional

This study evaluates the impact of reducing sitting time and increasing exercise time on cardiometabolic health in persons with Multiple Sclerosis.

NCT ID: NCT03918824 Recruiting - Nephropathy Clinical Trials

Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.

Start date: March 1, 2019
Phase:
Study type: Observational

Coronary heart disease remains one of the main causes of death in the world. One of the treatments for coronary heart disease is percutaneous coronary intervention (PCI). This requires the arterial administration of iodinated contrast medium (ICP) to visualize the state of the coronary arteries and possibly apply the treatment. For the vast majority of the population, exposure to ICP is perfectly well tolerated. Nevertheless, some complications can occur including a nephropathy induced by the injection of a contrast product (NIC). NIC is the third cause of an acquired acute renal failure within the hospital.It significantly increases morbidity and mortality and prolongs the hospital stay. Of all the procedures requiring ICP administration, PCI is associated with the highest rate of NIC.This evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologies.Age, preexisting alteration of renal function, diabetes mellitus, polypharmacy, congestive heart failure, type and volume of iodinated contrast medium are the main risk factors for developing NIC. Nowadays, the use of PCI in the assessment of coronary heart disease in patients with these risk factors is becoming more frequent. This is linked to the aging of the population and the increasing incidence of cardiovascular diseases. ICP-induced nephrotoxicity results from two main phenomena: the renal medullary hypoxia caused by the vasoconstriction of peritubular capillaries and a direct cytotoxicity towards tubular epithelial cells.These intra-renal mechanisms lead to an acute renal function impairment.NIC is defined as an increase of serum creatinemia ≥ 0.5 mg / dL (or a 25% increase) from the baseline in the 48-72h following PC injection with no other obvious etiology. It reaches its peak between the 3rd and 5th day with a resolution in 10 to 21 days. The prevention of NIC based primarily on the identification of patients at risk and the use of pharmacological means (as hydration protocol). In contrast, there is little data on the relationship between NIC and the PCI volume used. To the investigator's knowledge, the threshold of toxic volume is not well defined. Taking into account these elements, the investigators propose to study the relation between the volume of iodinated contrast product injected during an ICP and the occurrence of a NIC according to the criteria mentioned above.

NCT ID: NCT03917706 Recruiting - Clinical trials for Congenital Heart Disease

Development of a Quality of Life Assessment Tool for Adult Patients With a Congenital Heart Disease, Having Had Surgery During Childhood

Start date: April 1, 2018
Phase:
Study type: Observational

The mortality due to congenital heart diseases has decreased in recent decades, even for infants with the most complex lesions.Therapeutic advances have prolonged the lifespan of people with these diseases. However, there are specific social and psychological troubles that appear later in life and can compromise employability, insurability and social integration. There are different types of congenital heart disease: those not operated in adulthood, and those operated for curative or palliative purposes. It is estimated that about 10 out of 1000 babies are born with a congenital cardiac malformation. One-third of these have a critical diagnosis requiring a surgical intervention. Data from the literature show that there is an unusually high prevalence of psychosocial, neurological, developmental and psychiatric disabilities among survivors, as they enter formal education.There are many factors that influence developmental outcomes at school age. Early intervention is an essential element in controlling these comorbidities. The continuous monitoring of the development by a multidisciplinary team would make it possible to identify a developmental disorder as soon as it appears and respond to it as quickly as possible.For many children and their families, the burden of the developmental consequences is higher than the daily impact of the heart disease. Most studies and measures of quality of life in congenital heart patients require methodological improvements.They contribute little to the scientific basis of the quality of life in these patients. Future quality of life studies must invest in rigorous conceptualization, adequate operational definition and a good measure of quality of life. The investigators propose to develop a reproducible and reliable quality of life measurement tool, suitable for adult patients suffering from congenital heart disease and having had surgery during childhood.

NCT ID: NCT03917680 Recruiting - Angio Edema Clinical Trials

Evaluation of New Markers in Type 3 Angioedema

Start date: October 29, 2018
Phase: N/A
Study type: Interventional

Angioedema is a common condition, with multiple etiologies. Type 3 angioedema is caused by an increase in kininogenase activity responsible for an increased production of bradykinin. In some cases, it may be associated with clotting factor 12 mutations. However, other genetic abnormalities remain to be identified. Clinically, this angioedema type 3 is similar to types 1 and 2. The patient's vital prognosis is good if the diagnosis is made and if they have access to the appropriate treatment. Otherwise a significant morbidity is associated with it, hence the importance of being able to define a diagnostic marker. Videocapillaroscopy might be able to highlight abnormalities in the microcirculation of patients with a clinical display of angioedema. The purpose of this study is to highlight markers allowing to make an early diagnosis of angioedema. Functional analysis of factor XII in patients with symptoms of angioedema may be an interesting marker for diagnosis. Microcirculation abnormalities will also be evaluated by videocapillaroscopy, which may be another indicator of the disease.

NCT ID: NCT03917667 Recruiting - Sarcopenia Clinical Trials

Sarcopenia in Acute Care Patients: Protocol for Sarcopenia 9+

Start date: April 2, 2019
Phase:
Study type: Observational

Sarcopenia is a disease characterized by progressive and generalized loss of skeletal muscle mass and strength, and is related to worse clinical outcomes, physical impairment, and mortality in all healthcare settings. This nutrition-related syndrome is a reversible condition, and can be effectively counteracted by exercise and nutritional support. The prevalence of sarcopenia varies widely depending on the criteria, methods, and cut-off points used for its assessment. Although the European Working Group on Sarcopenia in Older People (EWGSOP) recommended assessing sarcopenia in geriatric patients in all care settings, few studies addressing hospitalized older patients have been carried out, mainly due to the characteristics of acute healthcare settings and their in-patients and because the criteria used are difficult to carry out there. Therefore, this condition remains under-recognized in the setting where this disease is likely to be more present. Sarcopenia is expected to be a major healthcare problem in the upcoming years in Europe so, in response to this claim for Public Health Action, the European Union Geriatric Medicine Society founded the Special Interest Group (SIG) on sarcopenia that has taken the lead of bridging the gaps between clinical and research in sarcopenia field, in line with the Conference on Frailty and Sarcopenia Research Task Force, and the World Health Organization's strategies to promote Optimal Aging. This goal of SIG on sarcopenia by EuGMS is being carried out by promotion of collaboration among International scientific societies and institutions; they have recently launched the Revised European consensus on definition and diagnosis (EWGSOP2), the SARCUS project on ultrasound for sarcopenia assessment in European countries, and the first International Registry of patients with sarcopenia. This study aims to provide an overview of sarcopenia assessment older patients hospitalized in acute-care geriatric units. This is a longitudinal, prospective, observational study in consecutive hospitalized patients in the CHU Brugmann Hospital. This study has 5 objectives : 1. To determine prevalence of sarcopenia among hospitalized patients in CHU Brugmann. 2. To determine incidence of sarcopenia during the hospital stay. 3. To identify risk factors for the development of sarcopenia at the time of admission and during hospitalization. 4. To assess sarcopenia as a risk factor for clinical adverse outcomes during hospitalization (hospital-acquired infections, falls, delirium, longer length-of-stay, disability, and mortality). 5. To assess sarcopenia as a risk factor for clinical adverse outcomes post-discharge (institutionalization, hospitalizations, falls, disability, and mortality) at 3- and 12-month follow-up.

NCT ID: NCT03917225 Recruiting - Friedreich Ataxia Clinical Trials

A Clinical Study to Evaluate the Effect of MIN-102 on the Progression of Friedreich's Ataxia in Male and Female Patients

FRAMES
Start date: March 26, 2019
Phase: Phase 2
Study type: Interventional

Randomized, double-blind, placebo-controlled study on the effects of MIN-102 on Biochemical, Imaging, neurophysiological, and clinical markers in patients with Friedreich's Ataxia