Clinical trials

The aim of this clinical trial is to learn whether a thirst-driven, liberal fluid-intake strategy is comparable to a fluid-restriction strategy in patients hospitalized for acute decompensated heart failure (ADHF). The study will also assess the safety of the intervention and its effects on thirst and quality of life. Patients hospitalized with ADHF will be asked to follow either a thirst-driven fluid-intake strategy or a fluid-restriction strategy during their hospital stay and for one month after discharge.

Irregular heart rhythms, known as atrial fibrillation or atrial flutter, are common conditions that can increase the risk of stroke and heart failure. A standard treatment to restore a normal rhythm is a controlled electric shock, known as cardioversion. However, if the irregular rhythm has lasted more than 24 hours, if the duration is uncertain, and if the patient has not been on blood-thinning medication for at least three weeks, doctors must first check for blood clots in the heart. This is done using a special ultrasound scan of the heart through the food pipe. Both the scan and the electric shock treatment require sedation to make the patient relaxed or asleep. The scan uses mild sedation from a cardiologist, while the shock needs a stronger sedative given by an anaesthesiologist. But needing this extra doctor can cause delays, so patients often wait longer for treatment and to go home. This study will test whether a cardiologist can safely handle both steps using a sedative called midazolam. This study will include 220 adults at multiple hospitals in Denmark and compare this new approach to standard care. Researchers will track how quickly patients go home, how well the treatment works, any serious side effects, what patients think about the experience, and how much money can be saved. If proven safe and effective, this new method could reduce treatment delays, shorten hospital stays, and lower healthcare costs-ultimately improving care for patients and making the healthcare system more efficient.

In Denmark, around 25,000 children under 18 undergo general anesthesia annually. Hospital stays and anesthesia can induce significant anxiety and stress in children due to unfamiliar environments, procedures, and communication issues. This anxiety can be linked to postoperative complications such as emergence delirium and may negatively impact both the child and their family's well-being. Engaging patients actively in their healthcare, including pediatric cases, is essential for improving outcomes. Assessing perioperative patient and family outcomes, particularly through patient-reported outcome measures (PROM) and patient-reported experience measures (PREM), can significantly enhance the quality of care provided to children. While PROMs are widely used in adults, they are less common in pediatric settings. The Pediatric Scale for Quality of Recovery (PedSQoR), developed by Australian and American researchers, is one such tool designed to measure recovery in children. This study aims to translate andvalidate the PedSQoR for Danish children aged 4-12. Furthermore, no existing instruments comprehensively assess pediatric surgery patients' experiences under general anesthesia, particularly from the child's perspective without relying on parents as proxies. Empowering children to express their healthcare experiences gives healthcare workers an insight into what matters for children and gives children a more positive outlook on healthcare, benefiting lifelong engagement. Study Aims and Objectives: The study aims to enhance the assessment of children's outcomes and experiences in perioperative settings, ultimately improving pediatric perioperative healthcare. The objectives include: 1. Translation and Adaptation: a. Translate and adapt the PedSQoR for Danish children aged 4-12. b. Validate the Danish PedSQoR version. 2. Development of a PREM Instrument: a. Develop a comprehensive PREM for children's experiences during surgery and anesthesia. b. Pilot-test and adjust the PREM questionnaire with a group of children aged 4-12. Study Methods: 1. PedSQoR Translation and Validation: A single-center prospective cohort study will adapt and test the PedSQoR for Danish children. The process involves translating the 21-item scale, validating it with a sample size of 150, and ensuring reliability through various statistical methods, including Cronbach's Alpha and test-retest reliability. Data will be collected from the Department of Anesthesiology and Intensive Care at Gødstrup Hospital. 2. PREM Instrument Development: This study will develop a PREM instrument using the Warwick Patient Experiences Framework (WaPEF), which encompasses seven dimensions of patient experience. The process will involve forming a panel of child experts, conducting focus groups, and translating insights into a pictorial questionnaire. The PREM will undergo pilot testing with 20 children to validate its effectiveness in capturing the dimensions of the WaPEF. Research Ethics: Given the vulnerability of children in research, this study will prioritize their safety and comfort, ensuring the study's benefits outweigh any potential risks. Informed consent will be obtained from both parents and children. The study will be registered with the Region Central Denmark's list of research projects and will not require approval from the Scientific Ethics Committee.

The goal of this observational study is to learn about current pre-anaesthesia practices in Denmark and patients' experiences of pre-anaesthesia consultations as well as what matters to patients before anaesthesia. The questions the study aims to answer are: What are the current pre-anaesthesia practices in Danish public hospitals. How do patients experience pre-anaesthesia consultations in Danish public hospitals. What matters to patients before anaesthesia in Danish public hospitals. On the day of surgery, patients answer an online survey about what matters to them when undergoing anaesthesia and whether they spoke with an anaesthesiologist or nurse anaesthetist about the anaesthesia. Data from the medical chart are obtained to support patients responses. For patients receiving a pre-anaesthesia consultation, we will summarise the degree of person-centredness experienced by patients.

People with end stage kidney disease cannot regulate salt and water normally, which often leads to high blood pressure, fluid overload, and a higher risk of heart disease. Hemodialysis is a life sustaining treatment that removes waste products, excess fluid, and electrolytes from the blood. However, the treatment itself can influence blood pressure and how the blood vessels function. Many patients experience symptoms such as thirst, headaches, fatigue, and swelling, which affect both daily well being and long term health. One possible way to reduce these problems may be as simple as adjusting the amount of sodium in the dialysis fluid. During dialysis, substances move between the patient's blood and the dialysate, the special fluid used in the machine. Sodium is one of the most important components because it helps regulate fluid balance and blood pressure. A higher sodium concentration in the dialysate can make patients feel more thirsty, cause them to drink more, and lead to fluid retention and higher blood pressure. On the other hand, lowering sodium too much can cause dizziness, low blood pressure, cramps, and discomfort during treatment. Because of this, there is ongoing debate about what the "right" sodium level should be. Too much sodium over time may also harm the blood vessels. The inner lining of the vessels, called the endothelium, is protected by a thin layer known as the glycocalyx. This layer helps prevent sodium from entering the vessel wall and supports the production of nitric oxide, a molecule that relaxes blood vessels and reduces inflammation. High salt exposure can damage the glycocalyx and reduce nitric oxide production, making the vessels stiffer and raising blood pressure. In dialysis patients, low nitric oxide levels are linked to worse outcomes and episodes of rising blood pressure during treatment. Some small studies suggest that lowering dialysate sodium can improve blood pressure and endothelial function, but larger studies have not shown clear effects on survival. This indicates that we still do not fully understand which patients benefit most or how sodium changes affect both physical and subjective symptoms. This study aims to fill these knowledge gaps by examining how a lower sodium concentration in the dialysate affects blood pressure, blood vessel function, fluid overload, inflammation, and patient reported symptoms. The goal is to provide new insights that could help tailor dialysis treatment to individual patients in a simple and cost effective way. The study will compare two sodium concentrations: a lower level (133 mmol/L) and the standard level used in many clinics (139 mmol/L). Twenty five patients receiving chronic in center hemodialysis will participate. Each patient will undergo both treatments for three weeks each, in random order, with a two week washout period in between. This crossover design allows each patient to serve as their own control, making it easier to detect meaningful differences. The main outcome is the difference in 24 hour systolic blood pressure between the two sodium levels. Secondary outcomes include changes in nitric oxide levels in the blood, measures of fluid overload using two different techniques, markers of inflammation, arterial stiffness, and patient reported symptoms such as thirst, fatigue, and overall well being. The study will also compare two methods for assessing fluid overload: bioimpedance spectroscopy and a newer carbon monoxide rebreathing technique. Blood pressure and arterial stiffness will be measured over 44 hours using a portable device. Blood samples will be collected to analyze nitric oxide, inflammatory markers, and sodium handling in red blood cells. Fluid status will be measured using both bioimpedance and the CO rebreathing method. Patients will complete a weekly questionnaire developed together with dialysis patients to capture their experiences and symptoms.

The goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. The study focuses on people with Turner syndrome (TS). The aim is to find out if there are specific DNA methylation patterns and/or RNA expression profiles linked to sensorineural hearing loss (SNHL) in people with TS. Additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile. The main question it aims to answer is: Does epigenetics constitute a common denominator for some of the unexplained SNHL cases? Turner Syndrome (TS) represents an ideal model for studying epigenetics related to sensorineural hearing loss (SNHL). Participants will undergo the following tests: * Ear examinations * Hearing tests * Balance tests * Blood tests * MRI scans * CBCT (cone-beam computed tomography) scans

The study aims to study the effects of diatery nitrate in patients with hypertension and hypertensive kidney injury. The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice. Effect variables will be measured before and after a 2 week treatment. After a washout period of 14 days, the subjects are crossed over to the opposite treatment. The study is terminated by measuring effect variables after the second treatment period.

The goal of this intervention study is to study the effect of nutritional interventions in patients with cancer receiving palliative chemotherapy. The main question it aims to answer is: Does early nutritional interventions affect body weight, quality of life, survival, muscle mass, performance status, physical function, nutritional risk and treatment tolerance in patients with cancer receiving palliative chemotherapy? Researchers will compare patients receiving the intervention to a historical control cohort following current clinical practice.

We will establish a cohort of 570 symptomatic chronic coronary syndrome patients undergoing 15O-water PET and assess their symptoms through repeated questionnaires. Two hundred patients with abnormal perfusion will be randomized to immediate or delayed referral to invasive coronary angiography with concomitant optimization of guideline-directed medical therapy with repeated 15O-water PET and questionnaires at 3 and 6 months. The primary objective is to compare the potential benefit of early invasive coronary angiography (ICA) versus guideline directed medical therapy (GDMT) on symptomatic relief defined as freedom of angina after 3 months following a positive \[15O\]H2O cardiac PET/CT in patients with symptomatic chronic coronary syndrome.

The goal of this age-based cohort study is to provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics. The participants will be children in the age of 6 months to 10 years, without any known hearing or balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.

The goal of this prospective cohort study is to investigate the vestibular function in children suspected of balance disorders, and to follow up on their balance progressions after rehabilitation. The main hypothesis of the study is that delayed gross motor development and symptoms of dizziness and balance problems in some children are caused by vestibular dysfunction. The investigators expect that early detection and rehabilitation by a physiotherapist will improve the balance ability for the child. The participants will be children in the age of 6 months to 10 years with delayed gross motor development and/or with dizziness/balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.

The goal of this prospective cohort study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss. The main hypothesis of the study is that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss. The participants will be children in the age of 3-10 years with sensorineural hearing loss. The test protocol consists of questionnaires and vestibular and postural assessments.

A randomized, placebo-controlled, double-blinded crossover study will be conducted. Fourteen patients with polycystic kidney disease (PKD) and 29 patients with proteinuric kidney disease will receive ketone bodies (Ketone-IQ) and placebo in a randomized order. Each treatment period is four weeks. There will be a wash-out period of two weeks in between treatment periods. Effect variables will be measured in the last day of each treatment period.