Continuous Sedation in Initially Sedated Adults in ICU Clinical Trial
— ProdexOfficial title:
A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Propofol for Continuous Sedation of Ventilated Patients in Intensive Care Unit
Patients in the ICU who need help with their breathing are put onto a machine called a
ventilator and are also given a medicine, called a sedative, which helps them to sleep and
makes them more comfortable. Propofol is a sedative that is routinely used for these
purposes.
For most patients the aim of sedation is to make them sleepy but still able to respond to
nursing staff (light sedation).
Dexmedetomidine is a new sedative for use in intensive care and in this clinical
study,dexmedetomidine is compared to propofol. It is thought that dexmedetomidine might be
slightly better at allowing patients to be sleepy but still respond to people around them.
It also does not appear to affect patient's breathing. The purpose of this study is to test
whether dexmedetomidine really does have these advantages compared to propofol.
In this study, we hope to show that: dexmedetomidine is at least as good as propofol in
helping patients to sleep better and making them more comfortable, and that they are able to
communicate and cooperate better with the staff treating them, and that patients treated
with dexmedetomidine require a shorter time on the ventilator than those treated with
propofol.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | March 2010 |
| Est. primary completion date | March 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age more than 18 years - Clinical need for sedation of an initially intubated (or tracheotomised) and ventilated (with inspiratory assistance) patient - Prescribed light to moderate sedation (target RASS = 0 to -3) using propofol - Patients should be randomised within 72 hours from ICU admission and within 48 hours of commencing continuous sedation in the ICU - Patients should have an expected requirement for sedation more than 24 hours from time of randomisation - Written informed consent must be obtained according to local regulations before starting any study procedures other than pre-screening Exclusion Criteria: - Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury - Uncompensated acute circulatory failure at time of randomisation (severe hypotension with mean arterial pressure [MAP] < 55 mmHg despite volume and pressors) - Severe bradycardia (heart rate [HR] < 50 beats/min) - AV-conduction block II-III (unless pacemaker installed) - Severe hepatic impairment (bilirubin > 101 µmol/l) - Need for muscle relaxation at the time of randomisation (may only be used for intubation and initial stabilization) - Loss of hearing or vision, or any other condition which would significantly interfere with the collection of study data - Burn injuries requiring regular anaesthesia or surgery - Use of centrally acting a2 agonists or antagonists at the time of randomisation, notably clonidine - Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis - Patients receiving sedation for therapeutic indications rather than to tolerate the ventilator (e.g. epilepsy) - Patients who are unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barré syndrome) - Patients who are unlikely to be weaned from mechanical ventilation e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis) - Distal paraplegia - Positive pregnancy test or currently lactating - Received any investigational drug within the preceding 30 days - Concurrent participation in any other interventional study (any study in which patients are allocated to different treatment groups and/or non-routine diagnostic or monitoring procedures are performed) - Previous participation in this study - Any other condition which, in the investigator's opinion, would make it detrimental for the subject to participate in the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Onze-Lieve-Vrouw Ziekenhuis, Anesthesia and Intensive Care Dept. Moorselbaan 164 | Aalst | |
| Belgium | Ziekenhuis Oost-Limburg Location Sint-Jan, Dept.of Anesthesiology, Schiepse Bos | Genk | |
| Finland | HUCH, Jorvi Hospital, Turuntie 150, | Espoo | |
| Finland | HUCH, Meilahti Hospital, Haartmaninkatu 4, P.O.Box 340, | Helsinki | |
| Finland | North Carelia Central Hospital, Tikkamaentie 16, | Joensuu | |
| Finland | Kuopio University Hospital | Kuopio | |
| Finland | Paijat-Hame Central Hospital, Keskussairaalankatu 7, | Lahti | |
| Finland | South Carelia Central Hospital, Valto Kakelan katu 1, | Lappeenranta | |
| Finland | Seinajoki Central Hospital, Hanneksenrinne 7, | Seinajoki | |
| Finland | Tampere University Hospital, ICU, Teiskonntie 35, P.O.Box 2000, | Tampere | |
| Germany | Charite Berlin Klinik fur Anasthesiologie und Operative Intensivmedizin (CCM), Luisenstrasse 65 (LU 65), | Berlin | |
| Germany | Universitatsklinikum Bonn, Klinik u. Poliklinik f. Anasthesiologie u. | Bonn | |
| Germany | Universitatsklinikum, Krankenhausstrsse 12, | Erlangen | |
| Germany | Klinikum der Johann-Wolfgang-Goethe Universitat, Klinik fur Anasthesiologie, | Frankfurt am Main | |
| Germany | Univ. Giessen und Marburg Abt. Anaesthesiologie, Intensivmedizin, Schmerztherapie & Palliativmedizin, Rudolf-Buchheim-Strasse 7, | Giessen | |
| Germany | Universitatsklinikum Halle, Universitatsklinik fur Anasthelsiologie und Operative Intensivmedizin, Ernst-Grube Strasse 40 | Halle | |
| Germany | Universitatsklinikum Heidelberg Klinik fur Anasthesiologie, Im Neuenheimer Feld 110, | Heidelberg | |
| Germany | Klinik fur Anasthesiologie, Intensivmedizin und Schmerztherapie, Universitatsklinikum des Saarlandes, Gebaude 57, | Homburg | |
| Germany | Klinikum St. Georg, Delitzscher Strasse 141, Hause 20, 1. Etage, Zimmer 204 | Leipzig | |
| Germany | Universitatsklinikum Leipzig, Klinik und Poliklinik fur Anaesthesiologie und Intensivtherapie, Liebigstrasse 29 | Leipzig | |
| Germany | Universitatsklinikum Tubingen, Klinik fur Anasthesiologie und Intensivmedizin | Tubingen | |
| Germany | Klinikum-Wetzlar-Braunfels, Forsthaus Strasse 1-3a | Wetzlar | |
| Netherlands | Jeroen Bosch Ziekenhuis, Postbus 90153, | Hertogenbosch | |
| Netherlands | Westfries Gasthuis, Department Intensieve Zorgen, Maelsonstraat 3, | Hoorn | |
| Netherlands | Rivierenland Hospital, Pres. Kennedylaan 1, | Tiel | |
| Russian Federation | Kemerovo Stte Medical Academy, 22/A Voroshilov Street | Kemerovo | |
| Russian Federation | Federal State Institution Russian Centre of Functional Surgical Gastroenterology, Krasnodor Municipal Hospital, 4, ulica Sedina, | Krasnodar | |
| Russian Federation | Municipal Hospital #2, Krasnodar Diversified Treatment and Diagnostic Association, 6, Ulica Krasnykh Partizan Building 2, | Krasnodar | |
| Russian Federation | State Institution B.B. Petrovsky Russian Research Centre of Surgery of RAMS, 2, Abrikosovsky per. | Moscow | |
| Russian Federation | State Healthcare Institution V.A. Baranov Republican Hospital, 3, Pirogova Ulica, | Petrozavodsk | |
| Russian Federation | Federal State Healthcare Institution L.G. Sokolov Clinical Hospital, #122 of FMBA of Russia, 4, pr-t Kultury | St .Petersburg | |
| Russian Federation | Medical Academy of Postgraduate Study, 41, ulica Kirochnaya, | St. Petersburg | |
| Switzerland | Inselspital, Freiburgstsrasse 4, | Bern | |
| United Kingdom | West Suffolk Hospital NHS Trust, Hardwick Lane, Suffolk, | Bury Saint Edmunds | |
| United Kingdom | Edinburgh University, Little France Crescent, Edinburgh Royal Infirmary, | Edinburgh | |
| United Kingdom | Leeds General Infirmary, Great George Street | Leeds | |
| United Kingdom | Saint John's Hospital, Howden Road West, | Livingston | |
| United Kingdom | Saint George's Hospital, Blackshaw Road, Tooting | London | |
| United Kingdom | Saint Thomas Hospital, Lambeth Palace Road, | London | |
| United Kingdom | Freeman Hospital, Freeman Road High Heaton,Newcastle Upon Tyne | Tyne and Wear |
| Lead Sponsor | Collaborator |
|---|---|
| Orion Corporation, Orion Pharma |
Belgium, Finland, Germany, Netherlands, Russian Federation, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Depth of sedation using the RASS. The target RASS range (target depth of sedation) should be 0 to -3 for a patient to be included in the study. The target may be amended during the study treatment, if clinically required. | 2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up | No | |
| Primary | Duration of mechanical ventilation | Start and stop times of mechanical ventilation while the patient is treated in the ICU | No | |
| Secondary | Nurse's assessment of subject communication with visual analogue scales (VAS) | At the end of each nursing shift during study treatment and 48 h follow-up period in the ICU | No | |
| Secondary | Length of ICU stay | Admission and discharge dates and times during the current ICU treatment period | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00481312 -
Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)
|
Phase 3 |