Clinical trials

The LIMIT-TBI trial is a multicenter, international, randomized, phase II clinical trial designed to evaluate the feasibility and safety of targeting a neutral fluid balance compared to standard care in critically ill adult patients with traumatic brain injury (TBI). Fluid therapy is a cornerstone of TBI management, but optimal fluid balance remains uncertain, with both fluid overload and restriction potentially leading to adverse outcomes. This study aims to determine whether maintaining a daily fluid balance close to zero (±500 mL) during the first 5 days of ICU admission is achievable and safe. Participants will be randomized within 48 hours of ICU admission to either a protocolized neutral fluid balance strategy or standard care. Outcomes include feasibility of achieving the target balance, organ complications, hemodynamic parameters, ICU resource utilization, and mortality and neurological outcomes up to 6 months.

Transcatheter aortic valve implantation (TAVI) is now the standard procedure for elderly patients with severe aortic stenosis. This patient group is characterised by increased frailty, multiple comorbidities and limited physiological reserve, exposing them to an increased risk of intraoperative complications. The majority of TAVI procedures are now performed under conscious sedation, in order to limit the risks associated with general anaesthesia and to promote a faster recovery. However, this strategy carries a risk of intraoperative respiratory events, notably bradypnoea, oxygen desaturation and airway obstruction, particularly in elderly patients with comorbidities. The anaesthetic strategy, and in particular the type of sedation used, is likely to influence intraoperative respiratory and haemodynamic tolerance. Traditionally used agents, such as propofol combined with opioids, can induce dose-dependent respiratory depression. Conversely, dexmedetomidine, an α2-adrenergic receptor agonist, has a distinct pharmacological profile, characterised by sedation with a theoretically limited respiratory impact. However, comparative data regarding the impact of different sedation strategies on intraoperative respiratory tolerance during TAVI remain limited, justifying the conduct of this study. Dexmedetomidine is a selective α2-adrenergic receptor agonist, used in anaesthesia and intensive care for its sedative and anxiolytic properties. It induces what is known as 'cooperative' sedation, characterised by the maintenance of relative alertness, the possibility of interacting with the patient and, above all, a limited impact on spontaneous breathing. Physiologically, dexmedetomidine differs from conventional sedatives, such as propofol and opioids, in causing less respiratory depression, making it a particularly attractive option for conscious sedation. This property is essential in elderly and comorbid patients, particularly during procedures such as TAVI, where maintaining spontaneous ventilation is a major concern. Several clinical studies, particularly in procedural sedation and interventional cardiology, suggest that the use of dexmedetomidine is associated with better respiratory tolerance, with a reduction in episodes of desaturation, bradypnoea and the need for airway interventions, compared with strategies based on propofol and opioids. However, data specific to the context of TAVI under conscious sedation remain limited, particularly regarding the prospective and standardised assessment of intraoperative respiratory events. This study therefore aims to address this knowledge gap by assessing the effect of dexmedetomidine, compared with standard sedation using propofol-remifentanil, on intraoperative respiratory tolerance in patients undergoing TAVI under conscious sedation.

Video-assisted thoracoscopic surgery (VATS) is associated with significant postoperative pain despite lower morbidity compared with thoracotomy. Adequate pain management is essential within Enhanced Recovery After Surgery (ERAS) pathways to preserve respiratory function and facilitate postoperative recovery. Surgical intercostal block performed under direct vision is a simple and effective regional analgesic technique commonly used following VATS. However, the optimal timing of intercostal block administration during surgery remains uncertain. This prospective randomized double-blind study will compare surgical intercostal block performed at the beginning versus the end of the surgical procedure. The study aims to evaluate the effect of block timing on postoperative pain intensity and postoperative opioid consumption. The results may help optimize multimodal analgesic strategies in patients undergoing thoracic surgery.

This retrospective, single-center observational study aims to evaluate the impact of fibrinogen concentrate reimbursement introduced in Belgium in April 1st, 2020, on transfusion practices in complex cardiac surgery. Adult patients undergoing complex cardiac surgery with cardiopulmonary bypass between Jan 1st 2016 and Dec 31st 2024 at Erasme Hospital will be included. Transfusion strategies and clinical outcomes will be compared between the pre-reimbursement and post-reimbursement periods.

This study aims to better understand how short periods of exposure to high oxygen levels affect blood flow in the brain of patients who are intubated and mechanically ventilated in the Intensive Care Unit (ICU). Many ICU patients receive more oxygen than strictly necessary, and high blood oxygen levels (hyperoxemia) are very common. However, the immediate effects of short hyperoxic exposures on cerebral circulation and autoregulation remain poorly understood. In this study, patients who already require mechanical ventilation for medical reasons will undergo a brief and controlled increase in the oxygen delivered through the ventilator (FiO₂). During this time, we will continuously monitor blood flow in one of the main brain arteries using a non-invasive ultrasound technique called transcranial Doppler (TCD). The goal is to evaluate how cerebral blood flow, pulsatility, and autoregulatory capacity change during and after a short hyperoxic stimulus. No additional invasive procedures are required beyond standard ICU monitoring, except for the temporary adjustment of the ventilator's oxygen settings and arterial blood gas sampling, which are part of usual care in critically ill patients. Participation does not provide direct clinical benefit but may help improve future oxygen management in ICU patients. The study involves minimal risk, as short hyperoxic exposures are already common in routine care and will be interrupted immediately in case of any adverse event.

Electrical Impedance Tomography (EIT) is a non-invasive, radiation-free, bedside imaging technique that has been in clinical use for over three decades (1). It is primarily utilized to monitor regional lung ventilation in mechanically ventilated patients. In recent years, EIT has become a routine tool in critical care settings due to its capacity to provide real-time, bedside insights into pulmonary function. Its applications are diverse, ranging from support during non-invasive ventilation and endotracheal intubation (2) to the management of complex cases of mechanical ventilation. One of its key advantages lies in guiding the optimization of Positive End-Expiratory Pressure (PEEP) titration, which may help tailor ventilatory support to individual patients and potentially reduce the mechanical power delivered to the lungs(3,4). Despite these benefits, current evidence does not conclusively demonstrate a reduction in mortality associated with the use of EIT in critical care (5,6). Nevertheless, EIT shows promise in several emerging areas, such as monitoring ventilation distribution during prone positioning - even in awake, non-intubated patients (7) - and in the early detection of atelectasis under various clinical conditions (8). Recently, advancements in EIT technology have led to the development of new models capable of assessing pulmonary "pulsatility," thereby expanding the potential clinical applications of EIT beyond traditional ventilation monitoring. This feature may facilitate the bedside detection of conditions such as atelectasis, pneumonia, pleural effusion, and even pulmonary embolism (9,10). In this context, the Intensive Care Unit at Erasme Hospital is acquiring two EIT devices to enhance diagnostic capabilities and improve the care of patients requiring either non-invasive or invasive ventilation during their ICU stay. To support the systematic implementation of these devices and enable future research, it is necessary to establish a registry documenting their clinical use within the ICU. This registry will serve as a foundation for tracking usage patterns, evaluating outcomes, and potentially contributing to future scientific studies. Standard ICU data such as SOFA scores and SAPS II will be recorded, as is already routinely done in some registries like Epimed. This registry will be specific to the Erasme ICU and will collect detailed data on ventilation parameters, EIT measurements, and recruitment maneuvers in patients undergoing mechanical ventilation-whether invasive or non-invasive-when the clinical team determines that a recruitment maneuver is indicated and chooses to use an EIT device for monitoring. Data will be entered into RedCap by the attending physicians or physiotherapists responsible for the patient. Data collection will be prospective, as it is not technically possible to automatically synchronize the recording of ventilation parameters and EIT measurements using the existing software systems. There are no expected risks for the patients, as the procedures involved are considered standard practice in intensive care settings. Patients may benefit from the collection of these data, as it allows for closer monitoring of ventilation parameters during their ICU stay. As this is a registry-based study, there will be no predefined duration or fixed number of patients. However, we estimate data will be recorded over a five-year period, with an inclusion of at least 300 patients per year. Inclusion Criteria for ICU Patients: * Patient aged more than 12 years old (no pediatric EIT belt) * Patient monitored by an EIT belt OR Patient undergoing a recruitment maneuver OR Patient undergoing prone position.

The goal of this observational study is to evaluate whether whole blood H3.1 nucleosome levels can predict 30-day mortality in adult critically ill patients admitted to the ICU with conditions such as sepsis, septic shock, cardiogenic shock, severe trauma, post-cardiac arrest, acute brain injury, or severe acute pancreatitis. The main questions it aims to answer are: Do initial whole blood H3.1 nucleosome levels predict 30-day mortality in critically ill patients? Are whole blood nucleosome measurements using a novel point-of-care device correlated with traditional plasma chemiluminescence immunoassays (ChLIA)? If there is a comparison group: Researchers will compare point-of-care whole blood nucleosome results with plasma ChLIA assays to see if the device provides reliable and feasible bedside measurements. Participants will: Provide blood samples at admission, 6h, Day 1, Day 3, and Day 7 for nucleosome analysis. Undergo point-of-care H3.1 nucleosome measurement and parallel plasma storage for ChLIA testing. (If applicable, in acute brain injury patients with external ventricular drains) provide daily cerebrospinal fluid samples until Day 5, only if otherwise discarded. Have standard ICU data (SOFA, SAPS II, etc.) collected as part of routine care.

the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.

Transverse maxillary deficiency is a common orthodontic issue, affecting around 10% of adults. Late adolescents and adults often require more force to expand the midpalatal suture due to its increased interdigitation. This study aims to assess the effectiveness of MARPE in this demographic and determine the best activation protocol for non-surgical maxillary expansion using mini-screw-supported appliances. Additionally, the study will evaluate the effectiveness of MARPE on nasal permeability and airway volume.

This study aims to examine whether multi-night closed-loop auditory stimulation (CLAS) during sleep can enhance waste clearance and memory consolidation in healthy adults and older adults with subjective cognitive decline or mild cognitive impairment who exhibit elevated brain amyloid levels identified through prior clinical screening. Specifically, the study investigates whether sleep stimulation increases the clearance of plasma biomarkers related to neurodegeneration, improves the brain's waste clearance system, and supports memory consolidation. Participants will undergo five nights each of CLAS and sham (no stimulation) interventions, with a washout period in between. They will also complete clinical assessments, including MRI scans, blood sample collection, and cognitive testing, and will keep track of subjective sleep quality, sleepiness, mood, and fatigue throughout the interventions.

Frozen embryo replacement cycle :Two methods traditionally used: the spontaneous cycle and the artificial cycle.Now, Emergence of new protocols: NPP-FET or "Natural proliferative phase - frozen embryo transfer" Demonstrate non-inferiority between the NPP-FET and the spontaneous cycle, and superiority in terms of planning.

The study is intended to test the hypothesis that sodium lactate infusion after resuscitation from a cardiac arrest will decrease the magnitude of brain damage, as measured by the serum biomarker concentration of NSE.

Neurovascular uncoupling (NVU) represents a major source of potential bias for the identification of eloquent brain regions through activation procedures in blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI). Same region shows proper pattern in glucose metabolism in victiny of brain lesions, investigated with positron emitted tomography with radiolabeled glucose (PET-FDG) This research project aims at investigating the mechanisms of NVU by using a multimodal noninvasive imaging approach in neurosurgical patients.

In our high volume center, the majority of esophagectomy procedures are performed with minimally invasive techniques. The thoracic epidural technique remains the gold standard and homolateral paravertebral catheter is strongly recommended. The vasoplegia and sympathetic blockade due to the epidural can cause significant hypotension especially as reverse Trendelenburg position is required during surgery. The aim is to study hemodynamic changes caused by two different techniques. Previous studies found a similar pain management between both locoregional techniques, however few studies suggested less side effects in the paravertebral group during major abdominal surgeries.

The goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. The main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor. Participants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. No change will be applied to clinical care as a result of this measurement.

To evaluate the effect of an anti-fibrotic treatment initiation on the fibrotic activity as assessed by FAPI PET/CT.

Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%. A first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS. This will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years. After the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting/regurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.

Surgical resection is the only potentially curative treatment for patients with pancreatic cancer with the aim of curative R0 resection and related improvement of survival. As a standard, surgery is usually followed by adjuvant therapy that improves survival but neoadjuvant therapy (NAT) is a rapidly emerging concept that needs to be explored and validated in terms of therapeutic options in borderline resectable pancreatic tumors. In this setting, preoperative FFX seems to be feasible and can be prolonged by radiation therapy. However, the exact and best therapeutic sequence is not yet known and the additional role of adding isotoxic high-dose stereotactic body radiotherapy (iHD-SBRT) to chemotherapy requires validation in randomised trials. We propose to evaluate the impact and efficacy of adding iHD-SBRT to preoperative neoadjuvant mFFX or Gem-NabP in patients with borderline resectable pancreatic adenocarcinoma.

SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.

While most of the children spontaneously recover menstruation or experienced normal puberty after chemotherapy, their ovarian reserve may be impaired by treatment inducing future infertility. Fertility preservation is currently proposed for selected prepubertal patients with a high risk of premature ovarian failure after treatment (mostly conditioning regimen for bone marrow transplantation). For patients with low or moderate risks, counselling is very difficult and no fertility preservation procedure is usually proposed for these patients as no marker of the ovarian reserve has been validated in this young population to assess the individual risk. The primary objective of the study is to prevent long-term treatment-related infertility by detecting the young patients who normally progressed to menarche but have a reduced ovarian reserve. These patients may benefit from particular follow-up and fertility preservation procedure.