Clinical Trials for Critical Illness
This article describes 6 ongoing clinical trials for patients with critical illness. These studies are testing different medications and treatment strategies to improve outcomes for patients in intensive care units who require mechanical ventilation, sedation, or other life-supporting therapies. The trials are being conducted in multiple European countries including Belgium, Finland, France, Germany, Ireland, Italy, Netherlands, and Spain.
Clinical trial locations
- Belgium
- Finland
- France
- Germany
- Ireland
- Italy
- Netherlands
- Spain
Study on Early Sedation with Dexmedetomidine vs. Placebo for Older Critically Ill Patients on Ventilators
This trial is testing whether early use of a sedative medication called Dexmedetomidine can improve survival and other outcomes in older patients who are critically ill and need help from a breathing machine.
Who can participate: Patients must be 65 years or older, currently on mechanical ventilation in an intensive care unit, and expected to need the breathing machine for at least two more days. They must also require sedative medication to stay comfortable and safe while receiving life support treatments.
Main focus: The primary goal is to evaluate whether using Dexmedetomidine as the main sedative can improve the 90-day survival rate compared to a placebo. The study will also examine how many days patients are awake and free from confusion, how many days they can breathe without the ventilator, and whether they experience major kidney problems.
Investigational drug: Dexmedetomidine is given through an intravenous infusion. This medication works by activating certain receptors in the brain to help calm patients and reduce the need for other sedatives. The trial is comparing it to a placebo to determine if it provides benefits for older critically ill patients on ventilators.
Study on Faster Weaning from Ventilators in Critically Ill Patients Using Levosimendan and a Drug Combination
This trial is investigating whether Levosimendan can help patients come off breathing machines more quickly. Many patients have difficulty stopping mechanical ventilation even after their initial illness improves.
Who can participate: Patients must be over 18 years old, have been on a breathing machine for more than 48 hours, and have already tried but failed at least one attempt to breathe on their own without success. Women who can become pregnant must have a negative pregnancy test.
Main focus: The study aims to see if Levosimendan can increase the number of days patients can breathe without a ventilator within a 28-day period. Researchers will also monitor blood pressure, heart rhythm, breathing comfort, and how long patients need to stay in the intensive care unit.
Investigational drug: Levosimendan is given through an intravenous infusion. This medication helps the heart pump more effectively by making the heart muscle stronger, which may help patients breathe on their own sooner. The trial compares it to a placebo in a double-blind design.
Study on Preventing Cardiovascular Collapse in Critically Ill Adults Using Noradrenaline Tartrate During Tracheal Intubation
This trial focuses on preventing serious drops in blood pressure during a procedure called tracheal intubation, where a tube is placed in the windpipe to help with breathing.
Who can participate: Patients must be 18 years or older, scheduled for urgent tracheal intubation in a hospital setting, have a life-threatening condition requiring intubation, and be planned to receive sedation. The procedure must be performed by someone who regularly does this in the hospital unit.
Main focus: The study aims to determine if giving Noradrenaline Tartrate before the intubation procedure can prevent cardiovascular collapse, where the heart and blood vessels fail to function properly. Researchers will monitor blood pressure to ensure it stays at safe levels and watch for cardiac arrest within 30 minutes of starting sedation.
Investigational drug: Noradrenaline Tartrate is given through an intravenous infusion. This medication increases blood pressure by constricting blood vessels. The trial is testing whether giving it preventively can reduce the risk of serious complications during intubation.
Study on Reducing Sodium Chloride and Glucose in Fluids for Critically Ill Patients
The CRUSADERS trial is exploring whether reducing the amount of salt (sodium chloride) in fluids given to patients in intensive care can improve their outcomes.
Who can participate: Patients must be at least 18 years old, admitted to the intensive care unit for medical or surgical emergencies, expected to need ICU care for at least two more days, and expected to receive at least 300 mL of unintentional fluid intake or at least 1 liter of maintenance fluid within the first 24 hours.
Main focus: The primary goal is to see if reducing salt content in IV fluids can improve survival and reduce the need for breathing and kidney support. The study will monitor for conditions like abnormal sodium levels, fluid retention, kidney injury, and blood sugar problems over 90 days.
Investigational approach: The trial tests different fluid solutions including sodium chloride alone, sodium chloride with glucose, glucose alone, and a balanced solution called Plasmalyte A that contains a mix of electrolytes. All fluids are given through an IV line directly into the bloodstream.
Study Comparing Isoflurane and Propofol for Sedation in Critically Ill Patients on Mechanical Ventilation
This trial compares two different sedation methods for patients on breathing machines to determine which allows patients to be free from the ventilator for more days.
Who can participate: Patients must be 18 years or older, on mechanical ventilation with an expectation to need it for at least 48 hours, and require deep sedation with a specific level of sleepiness measured on the RASS scale (between -3 and -5).
Main focus: The study aims to compare how many ventilator-free days patients have within 28 days when sedated with either Isoflurane (inhaled) or Propofol (intravenous). Researchers will also assess time spent in the ICU, how quickly patients can be taken off the ventilator after stopping sedation, and long-term mental health outcomes including anxiety, depression, and post-traumatic stress disorder.
Investigational drugs: Isoflurane is given through inhalation and works by enhancing certain brain chemicals to produce a calming effect. Propofol is given intravenously and works by enhancing the inhibitory effects of a neurotransmitter called GABA in the brain. Both are established sedation methods being compared for effectiveness in this population.
Study on Hydrocortisone and Fludrocortisone for Adults with Critical Illness-Related Corticosteroid Insufficiency
This trial studies a condition called Critical Illness-Related Corticosteroid Insufficiency (CIRCI), where the body cannot produce adequate levels of stress hormones during severe illness.
Who can participate: Patients must be adults (18 or older), hospitalized in an intensive care unit, have a SOFA score of 4 or higher for at least 6 consecutive hours (indicating organ dysfunction), and provide written consent or have consent provided by a legal representative. They must also be affiliated with a social security system or have universal health coverage.
Main focus: The study evaluates whether a combination of Hydrocortisone and Fludrocortisone can increase the number of days patients are alive and free from needing a ventilator or blood pressure medications within 30 days. Secondary outcomes include ICU and hospital length of stay, re-admission rates, and survival at different time points.
Investigational drugs: Hydrocortisone is given intravenously and mimics the natural hormone cortisol to reduce inflammation and support bodily functions. Fludrocortisone is taken orally and helps maintain proper salt and water balance by mimicking the hormone aldosterone. The combination is being tested against a placebo for up to seven days.
Summary
These six clinical trials represent diverse approaches to improving care for critically ill patients across Europe. The studies address key challenges in intensive care medicine including sedation management, ventilator weaning, blood pressure support during procedures, fluid management, and hormone replacement therapy.
Geographically, the trials show concentration in Western European countries, with Ireland and the Netherlands each hosting two trials. The studies involve different patient populations, from older adults (65+) to general adult ICU populations, and address various aspects of critical care.
Several trials focus on sedation strategies, comparing different medications and delivery methods (Dexmedetomidine, Isoflurane, and Propofol). Others target specific complications such as difficulty weaning from ventilators (Levosimendan trial), cardiovascular instability during intubation (Noradrenaline trial), and hormone insufficiency (Hydrocortisone and Fludrocortisone trial). The CRUSADERS trial takes a unique approach by examining fluid composition rather than adding new medications.
Common outcome measures across trials include ventilator-free days, survival rates, ICU length of stay, and quality of life assessments, reflecting the multifaceted goals of critical care: not just keeping patients alive, but helping them recover with the best possible functional outcomes.
