Le Folgoët, France

Complex Post-traumatic Stress Disorder: What Symptomatological Specificities

Post-Traumatic Stress Disorder manifests itself in a multitude of symptoms and self-regulation difficulties in various domains (somatization and biological balance, attention and consciousness, regulation of affects and impulses, interpersonal relationships and relational capacities, perception of the aggressor and of the aggression, self-perception and identity, sense and belief system) as well as profound changes in personality and various comorbidities .In addition, dissociation, the origin and the resulting disorders also have some similarities to Complex Post-Traumatic Stress Disorder. Indeed, dissociation is thought to have a traumatic origin and the symptomatology (eg hyperesthesia, dissociative amnesia, anesthesia) is included in Complex Post-Traumatic Stress Disorder. We can then ask ourselves the following questions: is Complex Post-Traumatic Stress Disorder a dissociative disorder in its own right causing difficulties with self-regulation? What is the share of dissociation in Complex Post-Traumatic Stress Disorder?

Influence of Preoperative Immunomodulation by Oral Impact on Postoperative Complications Following Cystectomies & Nephrectomies

Major surgery induces traumatic stress due to the surgical aggression which could lead to major postoperative complications and death when the patient organism is not ready or prepared to support this intense stress. Malnutrition can be caused by chronic starvation, chronic inflammatory disease and acute injury (stress, acute inflammation). Therefore, nutritional supplements are indicated for patients who do not meet their energy needs through oral food ingestion. Immune-modulating nutrient-enriched products containing arginine, Omega-3 polyunsaturated fatty acids (PUFAs), nucleic acids, vitamins and antioxidants (selenium) like ORAL IMPACT (Nestlé) can modulate immune and inflammatory processes in burn, trauma, major surgery and improving clinical outcomes. These immune-modulating nutrient-enriched products have shown their ability to decrease postoperative complications up to 50% in patients undergoing non-gastrointestinal major surgery and length of hospital and ICU stay (Jie B 2012, Drover 2011). Mortality benefits have been demonstrated in one study focused on Neck and Head surgery. (Buijs N, 2010) Before 2019, in our urology surgery setting, it seemed that the postoperative complications rate was clinically increasing despite reliable surgeons and excellent surgery techniques and procedures. It appeared that the sources of these complications might be the weakness of the patients against major surgical stress. Patients might have been malnourished. The nutritional status had been omitted from our preoperative anesthesia assessment and no perioperative nutritional rehabilitation had been performed. The effect of immune-modulating nutrient-enriched products had been demonstrated mostly in gastrointestinal surgery but also in non-gastrointestinal surgeries such as neck and head cancer surgery, gynecologic cancer surgery and cardiac surgery. There are not studies conducted in urologic major surgery. Reducing the number of post-operative complications is a major challenge in surgery because they cause an increase in the length of stay, which translates into higher hospital costs for the community. Surgery generates major metabolic stress that the human body must manage. This metabolic stress will manifest itself in an increase in catabolism and a decrease in anabolism, resulting in protein-energy malnutrition in the patient if they are insufficiently prepared. Preoperative undernutrition is one of the risk factors for major postoperative complications. Moreover, postoperative infection can occur despite the Oral Impact treatment and associated iron and protein-caloric rehabilitation. It is linked to postoperative hypoalbuminemia. The antimicrobial role of albumin in the body is significant due to its antioxidant power. Reduced, non-oxidized albumin is the primary antioxidant in the body. Postoperative inflammation consumes reduced albumin, thereby diminishing the body's antioxidant capacity and exposing it to complications and nosocomial infections. The exogenous supply of reduced albumin is therefore indispensable. The liver's albumin synthesis yield is too low in this inflammatory context, amounting to approximately one vial of 20% albumin per day. Preoperatively, the correction of any hypoalbuminemia is anticipated through the nutritional rehabilitation implemented with the dietitian team. The timing of the surgery does not always allow the body to correct this hypoalbuminemia on its own. It is also essential to correct it postoperatively, in case of complications if necessary, through the exogenous supply of 20% reduced albumin. Numerous studies have shown the benefit of perioperative Oral Impact immunomodulation in gastrointestinal surgery, ear, nose and throat surgery, gynecological and cardiac surgery. No studies have been done in major Urological surgery The proposed study will be the first formal evaluation of the benefits and risks of using ORAL IMPACT in the preoperative period of urological surgery. The choice of this clinical project for this research question is justified by the proven benefit of this food substitute perioperatively in gastrointestinal, ear, nose and throat, gynecological and cardiac surgery. We hypothesize that Oral Impact will protect against major postoperative complications and prolonged hospital stay for patients undergoing urological surgery. There are no current guidelines recommending or discouraging the prescription of ORAL IMPACT in urological surgery patients.

A Multicentre French Prospective Study of Children With Food Protein Induced Enterocolitis Syndrome in Its Acute Form

Food protein induced enterocolitis syndrome (FPIES), is a non-IgE mediated food allergy (FA) which seems to expand, and occurring in infancy. Prevalence of FPIES is unknown. In 2011, Katz published cumulative incidence of cow 'milk FPIES of 3 per 1000 new-borns, from prospective birth cohort in Israel. The offending food depend on the country, probably in relation to eating habits. Cow's milk (CM) is most commonly incriminated and can lead to a chronic digestive disease or in its acute form with potentially life-threatening vomiting/diarrhoea/dehydration, confusing with anaphylaxis. Rice and oat in US, or fish and egg in France are the solid food most often implicated. This disease is usually unknown by clinicians. Its diagnostic is based on clinical history, and differential diagnosis elimination. In 2017, an international workgroup of American Academy of Allergy, Asthma and Immunology published clinical criteria to specify the diagnosis and management. According to this last definition (JACI 2017), patient have to meet the major criterion and at least 3 minor criteria. Major criterion is vomiting in the 1- to 4-h period after ingestion of the suspect food and absence of classic IgE-mediated allergic skin or respiratory symptoms. Minor criteria are : 1. A second (or more) episode of repetitive vomiting after eating the same suspect food, 2. Repetitive vomiting episode 1-4 h after eating a different food 3. Extreme lethargy with any suspected reaction 4. Marked pallor with any suspected reaction 5. Need for emergency department visit with any suspected reaction 6. Need for intravenous fluid support with any suspected reaction 7. Diarrhea in 24 h (usually 5-10 h) 8. Hypotension 9. Hypothermia Skin prick test et IgE antibody are negative except atypical FPIES. Acute management begins with clinical evaluation, then administer normal saline bolus quickly. Parenteral ondansetron can be used to stop vomiting. Nutritional management implicate elimination of the offending foods. Only the oral food challenge in hospital can be done to determine resolution of FPIES after a long time of no symptom. The age of tolerance, depend of the food. The average age of acquiring tolerance for cow's milk changes in the literature, around 8-10 months in Korea, around 1 year in Israel, around 5 years in the United States. There is no data in France on the recovery age of CM-FPIES. However, there is a lack of information in literature for describe the evolution and atypical phenotypes. In addition, no prospective French series has been published to date. Our work is a national prospective study, which will collect news cases of acute FPIES diagnosis in sixteen French centres. Main objective: To determine the rate of acquisition of tolerance by food at 1 year, 2 years, 3 years post inclusion. Secondary objectives: - Description of a population of children with newly diagnosed FPIES. 2. Describe the rate of patients with FPIES progressing to IgE sensitization whatever the food at 1 year, 2 years, 3 years post inclusion. 3. Determine per food the rate of FPIES patients evolving towards IgE sensitization at 1 year, 2 years, 3 years post inclusion. 4. Describe the rate of patients with FPIES progressing to clinical symptoms of IgE-mediated allergy, whatever the food, at 1 year, 2 years, 3 years post inclusion. 5. Determine, by food, the rate of FPIES evolving towards clinical symptoms of IgE-mediated allergy at 1 year, 2 years, 3 years post inclusion. 6. Describe the rate of patients with multiple FPIES at each time point of the study. 7. Describe at each time the rates of patients with personal atopic comorbidities. The inclusion period will last three years, and the follow up of each patient will last three years. Allergologist will see the patient at inclusion visit, then one time a year. If the patient does not acquire tolerance, an oral food challenge (OFC) in hospital will lead to answer. The aim of our work will help allergologist to manage FPIES children, with French specificities in offending food, and tolerance.

HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome

For patients successfully resuscitated who got restoration of spontaneous circulation (ROSC) after cardiopulmonary resuscitation (CPR), the course is usually marked by a post-resuscitation syndrome including multiple organ failures of various intensity and anoxic brain damage. The cardiocirculatory failure usually dominates the clinical picture, and it often leads to multiorgan failure. This hemodynamic failure is multifactorial, including at various levels vasoplegia, myocardial dysfunction, endotoxin release and adrenal dysfunction and is at least partly related to a hormonal defect that could be counteracted by hormonal supplementation. Such a substitutive opotherapy by hydrocortisone and AVP could improve hemodynamic failure and decrease overall mortality in this setting. This trial is a superiority multicentric trial and patients will be randomized in a 1:1:1:1 ratio using an electronic CRF. Investigational medicinal products: - Arginin-vasopressin or AVP (REVERPLEG) The solution for infusion is prepared by diluting 40 I.U. REVERPLEG® with sodium chloride 9 mg/ml (0.9%) solution. The total volume after dilution should be 50 ml (equivalent to 0.8 I.U. AVP per ml). AVP will be administered according to mean arterial pressure to target a 65mmHg blood pressure for max 3 days. - HYDROCORTISONE HEMISUCCINATE Vials with lyophilisate (100mg hydrocortisone) are provided by SERB laboratory. Hydrocortisone hemisuccinate will be administered as a 50mg intravenous bolus every 6 hours after an initial dose of 100mg, for 7 consecutive days. Stop of treatment by hydrocortisone will be performed without tapering. Comparator treatment: placebos. 17 ICU centers in France will participate to this study targetting 380 patient's enrollment in the study.

Factors Associated With Clinical Outcomes in Patients Hospitalized for Covid-19 in GHT-93 Est

Healthcare centers treated several hundreds of patients with Covid-19 and prospectively gathered information in electronic format between March, 2020 to April, 2020. In the course of Covid-19 treatment, physicians employed several drugs, including hydroxychloroquine, azithromycin, lopinavir/ritonavir, tocilizumab, baricitinib, sarilumab, corticosteroids and systematic antibiotics (list is not exhaustive). This cohort study aims to assess factors associated with clinical outcomes in patients hospitalized for Covid-19. Risk factors which will be studied include: baseline characteristics such as medical history and drugs with corresponding administration protocols. Main outcomes include all-cause mortality, need for mechanical ventilation, for ICU transfer and all relevant biological syndromes. All data are collected in electronical records during routine practice and additional data may be collected retrospectively.

Inhaled vs IV Opioid Dosing for the Initial Treatment of Severe Acute Pain in the Emergency Department

Impact of a Systematic Palliative Care on Quality of Life, in Advanced Idiopathic Pulmonary Fibrosis.

Idiopathic pulmonary fibrosis (IPF) is a rare and severe disease with a survival median between 2 and 4 years which leads to a profound alteration of the quality of life. This alteration results from different consequences of the IPF: progressive shortness of breath, irritative cough refractory to treatments, exhaustion, limitation of activity, social isolation, and psychic consequences such as fear, anxiety and depression. The only current curative treatment of the disease is pulmonary transplantation, but it's only feasible for a minority of patients. Anti-fibrotic drugs, such as pirfenidone and nintedanib, are likely to slow the progression of IPF but have no impact on patients' quality of life. The symptomatic treatment aimed at relieving respiratory discomfort and the patient's quality of life is therefore fundamental, and the IPF meets in many ways the challenges of lung cancer. In thoracic oncology, the systematic and early intervention of a palliative care team result in an improvement of quality of life for patients. In the princeps study published in 2010, the early intervention of a dedicated palliative care team was compared to standard care in a randomized trial of 150 patients and shows a significant improvement : (i) of quality of life (main objective), (ii) of depression scores and even overall survival (11.6 months vs. 8.9 months, P = 0.02), (iii) a benefit in terms of understanding the diagnosis and therapeutic goals (3), (iv) diminution of adapted hospitalization in end of life (in emergency or not). Considering some analogy points between IPF and advanced lung cancer (prognosis, respiratory symptom, psychological burden), it seemed reasonable to assume that the joint systematic intervention of chest physician and palliative care team may provide a significant benefit in terms of quality of life for patients with severe IPF. Objective: To investigate the benefit on quality of life, evaluated after 6 months, of a systematic, formalized and joint intervention of a palliative intervention staff and a chest physician team compared to standard care for patients with severe IPF. Secondary endpoints 1. To evaluate the benefit of the systematic, formalized and joint intervention of a palliative care team and a chest physician team on: - Mood and depression - Understanding of diagnosis and therapeutic objectives, frequency of drafting of advance directives regarding end-of-life - Respiratory symptoms (cough and dyspnea) - The course of care, the use of palliative care stays and the duration of hospital stays (number and duration of hospitalizations). - Overall survival and place of death. 2. Carry out a medico-economic study evaluating the incremental cost-utility and cost-effectiveness ratio (overall survival criterion)

Evaluation of the Videodrama Therapeutic Device for Children with Autism Spectrum Disorders

Currently, managing children with ASD emphasizes compensating for communication and social interaction disabilities. Communication tools like PECS or Makaton and social skills groups have shown effectiveness but have limitations, particularly not addressing sensory atypicalities seen in children with ASD. These sensory atypicalities are evident when children watch videos on screens. The idea is to use video to understand the sensory experiences of children with ASD and help them move away from an isolated relationship with screens. New technologies can further isolate children with ASD in their autistic sphere. The hypothesis is that observing these children with screens will provide better understanding of their sensory experiences and improve therapeutic support towards play and interaction with others