Ongoing Clinical Trials for Delirium
Currently, there are 3 ongoing clinical trials investigating ways to prevent and manage delirium in patients undergoing surgery or requiring intensive care. These studies are exploring different medications and sedation strategies to reduce confusion and mental status changes that can occur in hospital settings, particularly after heart surgery or during mechanical ventilation in intensive care units.
Clinical trial locations
- Finland
- France
- Norway
Study on Dexmedetomidine and Clonidine Hydrochloride to Prevent Delirium in Patients Undergoing Open Heart Surgery
This trial is taking place in Norway and focuses on preventing delirium and cognitive decline in older patients undergoing open heart surgery. Delirium is a sudden change in mental status that causes confusion and reduced awareness of surroundings, and it commonly occurs after major surgery.
Who can participate: The study is looking for patients who are at least 70 years old and scheduled for heart surgery that uses a heart-lung machine. This includes procedures such as coronary bypass grafting, valve replacement or repair, surgery on the ascending aorta, or a combination of these. Participants must be able to understand and sign an informed consent form.
Who cannot participate: People who fall outside the specified age range or who do not belong to the selected clinical trial groups are excluded from this study.
What the trial involves: Researchers are testing two medications called dexmedetomidine and clonidine hydrochloride, which belong to a class of drugs known as alpha-2 adrenergic receptor agonists. These medications work by calming the nervous system and may help reduce the risk of confusion and memory problems after surgery. The medications will be given directly into a vein through an intravenous infusion for up to two days. Some participants will receive a placebo, which contains no active medication, to compare the effects.
Study goals: The main purpose is to determine whether these medications can effectively prevent delirium in patients after heart surgery. Researchers will monitor participants for mental status changes and overall health before and after surgery. They will assess how many days participants experience delirium, how severe it is, and whether there are any changes in cognitive function. Follow-up assessments will continue for up to 6 months after surgery to evaluate long-term recovery and mental health outcomes.
Study on the Effects of Dexmedetomidine on Brain Fluid Flow and Activity in Patients with Neurodegenerative Diseases, Delirium, or Acute Neurological Conditions
This clinical trial is being conducted in Finland and examines how a medication called dexmedetomidine affects brain function. The study uses advanced imaging techniques to observe changes in brain blood flow and the movement of cerebrospinal fluid, which is the clear liquid surrounding the brain and spinal cord.
Who can participate: The study is looking for healthy volunteers who are between 18 and 45 years old, right-handed, and fluent in Finnish. Participants must have a head circumference no larger than 59 cm, normal heart activity, normal blood pressure, and healthy oxygen levels in their blood. They should have a normal weight with a Body Mass Index between 18.5 and 30, show no signs of substance abuse, and have normal laboratory test results.
Who cannot participate: Patients with neurodegenerative diseases, those experiencing delirium, or those with acute neurological conditions are excluded from this particular trial.
What the trial involves: Dexmedetomidine is being tested for its effects on brain function. This medication is often used to help people feel calm and sleepy. In this study, it will be given directly into a vein while participants undergo functional MRI scans and electroencephalography tests to measure brain activity. Blood samples will also be taken to measure various health indicators.
Study goals: The trial aims to understand how dexmedetomidine influences brain functions, including blood flow and cerebrospinal fluid movement, while participants are awake and under different levels of sedation. This information will help researchers better understand the medication’s effects on brain health and its potential benefits for treating various neurological conditions.
Study on the Effects of Isoflurane and Propofol on Delirium in Intensive Care Patients on Mechanical Ventilation
This trial is taking place in France and focuses on patients in intensive care who require a breathing machine. The study compares two different sedation approaches to see which one is more effective at reducing delirium.
Who can participate: The study is open to patients aged 18 and over who need mechanical ventilation for at least 24 hours and require continuous sedation for comfort, safety, and to support life-saving treatments. Consent must be obtained from either the patient or a relative.
Who cannot participate: Patients outside the specified age range or those belonging to vulnerable populations requiring special protection are excluded from the study.
What the trial involves: The study compares an inhaled sedation method using isoflurane delivered through a special system called ANACONDA™ with traditional intravenous sedation using medications such as propofol and sufentanil. Isoflurane is administered as an inhalation gas, while propofol is given as an injection or infusion directly into a vein. These medications help keep patients calm and comfortable while on the breathing machine.
Study goals: The main purpose is to determine which sedation strategy is more effective in reducing the occurrence of delirium in intensive care patients. Researchers will also monitor other important outcomes such as length of stay in intensive care, mortality rates, the number of days patients can live without mechanical ventilation, and the quality of sedation. Additional assessments will look at the need for extra medication, use of physical restraints, and accidental removal of medical tubes. Cognitive and quality of life evaluations will continue for up to 12 months after the trial.
Summary
These three clinical trials represent ongoing efforts to better understand and prevent delirium in different hospital settings. Two trials are investigating the medication dexmedetomidine, with one focusing on older adults undergoing heart surgery in Norway and another examining brain function in healthy volunteers in Finland. The third trial in France is comparing different sedation strategies for intensive care patients on mechanical ventilation.
The studies span three European countries and involve different patient populations, from healthy volunteers to critically ill patients. While the Norwegian and French trials focus specifically on preventing or reducing delirium, the Finnish study takes a broader approach by examining how sedative medications affect brain function at a fundamental level. Together, these trials contribute valuable knowledge about the best ways to manage sedation and prevent confusion in hospitalized patients, with the ultimate goal of improving recovery and mental health outcomes.
