Continuous Sedation in Initially Sedated Adults in ICU Clinical Trial
— MIDEXOfficial title:
A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Midazolam for Continuous Sedation of Ventilated Patients in Intensive Care Unit
Patients in 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. Midazolam 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 midazolam. 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 midazolam.
in this study we hope to show that: dexmedetomidine is at least as good as midazolam in
helping patients to sleep better and making them more comfortable, and that they are able to
co-operate better with the staff treating them, and that patients treated with
dexmedetomidine require a shorter time on the ventilator than those treated with midazolam.
| Status | Completed |
| Enrollment | 501 |
| Est. completion date | October 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age 18 years and over - 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 midazolam infusion - 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 of at least 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 MAP < 55 mmHg despite volume and pressors) - Severe bradycardia (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 (see section 5.7 for prior and concomitant treatments) - Known allergy to any of the study drugs or any excipients of the study drugs - 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 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, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | ULB Erasme, Route de Lennik | Brussels | |
| Belgium | UZ Brussel, Intensive Care Dept. Laarbeeklaan 101 | Brussels | |
| Belgium | Universitaer Ziekenhuis Gent, Intensieve Zorgen, De Pintelaan 185 | Gent | |
| Belgium | CHU de Liege (Sart Tilman), Domaine de Sart-Tilman | Liege | |
| Estonia | East Tallinn Central Hospital, Ravi Stret 18 | Tallinn | |
| Estonia | North Estonian Regional Hospital, Centre of Intensive Care, J. Sutiste Tee 18 | Tallinn | |
| Estonia | North Estonian Regional Hospital, Dept. of Postoperative Intensive Care, J. Sutiste Tee 18 | Tallinn | |
| Estonia | Tartu University Hospistal, Clinic of Anesthesiology and Intensive Care, L. Puusepa 8 | Tartu | |
| Finland | Oulu University Hospital, Kajaanintie 50 | Oulu | |
| Finland | Tampere University Hospital, ICU | Tampere | |
| France | Centre Hospitalier Universitaire d'Angers, Reanimation medicale est de Mededicne Hyperbare, 4 Rue Larrey | Angers cedex 9 | |
| France | Centre Hospitalier Victor Dupouy Hopital Dupuytren, Service Reanimation Polyvalente, 69, Rue du Lt Colonel Prud'hon | Argenteuil | |
| France | Centre Hospitalier Universitaire de Grenoble, Service de Reanimation Medicale, Boulevard de la Chantourne, BP 217 | Grenoble cedex 09 | |
| France | Centre Hospitalier La Roche sur Yon CHD les Oudaireis, Service Reanimation CHD la Roche sur Yon, Les Oudairies | La Roche sur Yon Cedex | |
| France | Hopital Albert Calmette, Boulevard Du Pr. Jules Leclercq | Lille | |
| France | Centre Hospitalier Universitaire Limoges Hopital Dupuytren, Service de Reanimation Polyvalente, 2, Avenue Martin Luther King | Limoges | |
| France | Centre Hospitalier Universitaire d'Orleans, Reanimation Medicale, 1, rue Prote Madeleine, BP 2439 | Orleans cedex 1 | |
| France | Groupe Hospitalier Cochin Saint Vincent de Paul, Service de Reanimation Medicale, 27 Rue du Faubourg Saint Jacques | Paris | |
| France | Hopital Bichat-Claude, Dept. D'Anasehesie et Reanimation Chirurgicale, 46, rue Henri-Huchard | Paris | |
| France | Hopital Foch, Service Renimation, 40 Rue Worth, Suresnes Hauts de Seine | Paris | |
| France | Centre Hospitalier Universitaire de Poitiers, Reanimation Medicale, 2, Rue de la Miletrie | Poitiers | |
| France | Centre Hospitalier Regional et Universitaire - Hopital Bretonneau Service Reanimation Medicale Polyvalente, 2, Boulevard Tonnelle, Tours cedex 9 | Tours | |
| Germany | Universitatsklinikum Bonn, Klinik u. Poliklinik f. Anasthesiologie u. Operative Intensivmedizin, Sigmund-Freud-Strasse 25 | Bonn | |
| Germany | Universitatsklinikum Greifswald, Klinik u. Poliklinik f. Anasthesiologie u. Intensivmedizin, Friedrich-Loeffler-Str. 23b | Greifswald | |
| Germany | Universitatsklinikum Tubingen, Klinik fur Anasthesiologie und Intensivmedizin, Hoppe-Seyler-Strasse 3 | Tubingen | |
| Netherlands | VU Medisch Centrum, De Boelelaan 1117 | Amsterdam | |
| Netherlands | Gelre Hospitals - Locatie Lucas, A.Schweitzerlaan 32 | Apeldoorn | |
| Netherlands | Amphia Ziekenhuis, Dept. Intensieve Zorgen, Molengracht 21 | Breda | |
| Netherlands | Albert Schweitzer Hospital, Locatie Dordwikj, Albert Schweitzerplaats 25 | Dordrecht | |
| Netherlands | Kennemer Hospital, Boeerhaavelaan 29 | Haarlem | |
| Netherlands | Saint Elisabeth Ziekenhuis, Dept. Intensieve Zorgen, Hilvarenbeekseweg 60 | Tilburg | |
| Netherlands | Viecuri MC voor Noord-Limburg, Locatie Venlo, Dept. Intensieve Zorgen, Tegelseweg 210 | Venlo | |
| Netherlands | Isala Klinieken, Locatie Weezenlanden, Groot Wezenland 20 | Zwolle | |
| Norway | Haukeland University Hospital, Intensive Care Unit, Jonas Liesvei 65 | Bergen | |
| Norway | Aker Universtetssykehus HF, Anestesiavdelingen, Trondheimsveien 235 | Oslo | |
| Norway | Rikshospitalet, Universitetsklinikk, Sognsvannsveien 20 | Oslo | |
| Norway | Ulleval University Hospital, Medical and Surgical ICU, Kirkeveien 166 | Oslo | |
| Switzerland | Inselspital, Freiburgstrasse 4 | Bern | |
| Switzerland | Kantonsspital Winterthur, Brauerstrasse 15, | Winterthur | |
| Switzerland | Universitatsspital Zurich, Klinik fur Innere Medizin, Intensivstation, Ramistrasse 100 | Zurich | |
| United Kingdom | Birmingham Heartlands Hospital, Bordesely Green East | Birmingham | |
| United Kingdom | University Hospital Birmingham, Department of Anaesthesia, Queen Elizabeth Hospital, | Birmingham | |
| United Kingdom | Derriford Hospital, Dept. of Intensive Care Level 4, Derriford Road | Plymouth |
| Lead Sponsor | Collaborator |
|---|---|
| Orion Corporation, Orion Pharma |
Belgium, Estonia, Finland, France, Germany, Netherlands, Norway, 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 | RASS score will be assessed approximately 2 hourly during the treatment period and during the 48-hour follow-up period | Yes | |
| Primary | Duration of mechanical ventilation the number of days the patient receives mechanical ventilation will be recorded | This variable will be dependent on the individual patient and the number of days they require mechanical ventilation . | No | |
| Secondary | Nurse's assessment of subject communication with visual analogue scales (VAS)Patients rousability and ability to co-operate and communicate will be measured using a visual analogue scale. | This will be measured at the end of every nursing shift whilst the patient remains on study treatment (maximum 14 days) | Yes | |
| Secondary | Length of ICU stay | Number of days a patient is in ICU which will vary depending on the underlying illness of the patient | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00479661 -
Dexmedetomidine Versus Propofol for Continuous Sedation in the Intensive Care Unit (ICU)
|
Phase 3 |