Study on Early Sedation with Dexmedetomidine vs. Placebo for Older Critically Ill Patients on Ventilators

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What is this study about?

This clinical trial is focused on studying the effects of early sedation in older patients who are critically ill and require intensive medical care, including the use of machines to help them breathe, known as mechanical ventilation. The study involves patients who are 65 years or older and are in need of continuous sedative medication to ensure comfort and safety while receiving life-supporting treatments. The medication being tested is called Dexmedetomidine, which is given as a solution through an infusion. This trial compares the effects of Dexmedetomidine with a placebo, which is a substance with no active medication, to see if it can improve outcomes for these patients.

The main goal of the study is to evaluate the impact of using Dexmedetomidine as a primary sedative on the survival of patients over a period of 90 days. The study will also look at other important factors, such as the number of days patients are alive without experiencing coma or delirium, the number of days they are free from the ventilator, and any major kidney problems that may occur. Additionally, the study will assess how long patients need mechanical ventilation and their length of stay in the hospital.

The trial is expected to run until December 2025, with the recruitment of participants having started in August 2023. The findings from this study could help improve the care and treatment of older patients who are critically ill and require mechanical ventilation.

1 joining the study

Upon joining the study, the patient is confirmed to be 65 years or older and is currently receiving mechanical ventilation in an intensive care unit.

The patient requires ongoing sedative medication for comfort and safety, and it is expected that the patient will remain intubated and ventilated until at least the day after tomorrow.

2 medication administration

The patient receives either Dexmedetomidine or a placebo as a sedative. Dexmedetomidine is administered as a 100 micrograms/ml concentrate for solution via infusion.

The placebo consists of 2 ml of saline, manufactured under the same conditions as Dexmedetomidine.

3 monitoring and evaluation

The primary outcome of the study is to evaluate the 90-day all-cause mortality rate among patients.

Secondary outcomes include the number of days alive and free of coma and delirium at 28 days, the number of days alive and ventilator-free at 28 days, and the occurrence of major adverse kidney events at 28 days.

4 duration of participation

The study is estimated to conclude by December 1, 2025.

The patient’s participation involves ongoing monitoring and evaluation throughout the study period, with specific attention to the duration of mechanical ventilation and hospital length of stay in survivors.

Who Can Join the Study?

  • The patient must be 65 years of age or older.
  • The doctors believe the patient will need to stay on a breathing machine until at least the day after tomorrow. This means the patient is not expected to be taken off the machine the next day.
  • The patient is currently intubated (a tube is placed in the airway to help with breathing) and is receiving help from a mechanical ventilator in an intensive care unit.
  • The patient needs to have sedative medication right away. This medication helps keep the patient comfortable and safe, and it also helps with the delivery of life support treatments.

Who Cannot Join the Study?

  • Patients who are critically ill and need a high level of medical care, such as machines to help them breathe (mechanical ventilation).
  • Patients who require medications to support their heart and blood pressure, known as vasopressors.
  • Patients who need medications to help them relax or relieve pain, referred to as sedative/analgesic medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Rostock University Medical Center Rostock Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Stichting Radboud University Medical Center Nijmegen The Netherlands
Pirkanmaan hyvinvointialue Tampere Finland
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Hospital Clinic De Barcelona Barcelona Spain
Universitaetsklinikum Aachen AöR Aachen Germany
Beaumont Hospital Dublin Ireland
Tübingen University Hospital Tuebingen Germany
Uozersocdmsgtnwepjqcs Khwpzcetdlebqbwwpqyqgsx Brjsjq Gmmp Bochum Germany
Ucddmaiowajmkfkvyshnd Edyzl Aeu Essen Germany
Hputexuj Ucpabtcgip Cqbaunv Hifwkdyi Helsinki Finland
Ucxnsfvyzvicsincscgpy Mkacoigp Awt Munster Germany
St Vuacgnlaobuitwa Uwoxlyawky Htrnvhkm Dublin Ireland
Uusplbecetzsshwjveaix Aquwvwuk Augsburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not yet recruiting
01.08.2023
Germany Germany
Recruiting
01.08.2023
Ireland Ireland
Not yet recruiting
01.08.2023
Spain Spain
Not yet recruiting
01.08.2023
The Netherlands The Netherlands
Not recruiting
01.08.2023

Trial locations

Dexmedetomidine is a medication used in this trial as a sedative for older patients who are critically ill and require ventilation. It is being tested to see if it can improve survival rates when used early as the main sedative. The trial aims to verify previous findings that suggested benefits of using dexmedetomidine in similar situations.

Investigated diseases:

Acute Respiratory Distress Syndrome (ARDS) – This condition occurs when fluid builds up in the tiny, elastic air sacs in the lungs, preventing them from filling with enough air. As a result, less oxygen reaches the bloodstream, depriving organs of the oxygen they need to function. ARDS typically develops in people who are already critically ill or have significant injuries. It progresses rapidly, often within a few hours to days after the initial injury or illness. Patients may experience severe shortness of breath, labored and unusually rapid breathing, and low blood pressure. Mechanical ventilation is often required to support breathing.

Acute Kidney Injury (AKI) – This condition involves a sudden episode of kidney failure or damage that happens within a few hours or days. It causes a build-up of waste products in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. AKI can occur due to various reasons, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. The progression can lead to symptoms such as decreased urine output, swelling due to fluid retention, and fatigue. It is often seen in critically ill patients and can be reversible with appropriate care.

Trial ID:
2022-501157-36-00
Protocol code:
V1.0
Trial Phase:
Therapeutic confirmatory (Phase III)

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