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Dexmedetomidine Versus Propofol for Continuous Sedation in the Intensive Care Unit (ICU) (Prodex)

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ClinicalTrials.gov Identifier: NCT00479661
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : August 13, 2010
Sponsor:
Information provided by:
Orion Corporation, Orion Pharma

Tracking Information
First Submitted Date  ICMJE May 25, 2007
First Posted Date  ICMJE May 28, 2007
Last Update Posted Date August 13, 2010
Study Start Date  ICMJE May 2007
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2007)
  • 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. [ Time Frame: 2 hourly and before each rescue treatment dose during the treatment period and the 48-hour follow-up ]
  • Duration of mechanical ventilation [ Time Frame: Start and stop times of mechanical ventilation while the patient is treated in the ICU ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00479661 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2007)
  • Nurse's assessment of subject communication with visual analogue scales (VAS) [ Time Frame: At the end of each nursing shift during study treatment and 48 h follow-up period in the ICU ]
  • Length of ICU stay [ Time Frame: Admission and discharge dates and times during the current ICU treatment period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Versus Propofol for Continuous Sedation in the Intensive Care Unit (ICU)
Official Title  ICMJE A Prospective, Multi-centre, Randomised, Double-blind Comparison of Intravenous Dexmedetomidine With Propofol for Continuous Sedation of Ventilated Patients in Intensive Care Unit
Brief Summary

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.

Detailed Description

This is a phase III, multi-centre, prospective, randomised, double-blind, double-dummy, active comparator study. The study consists of three periods: screening, double-dummy treatment and follow-up period.

All patients admitted to ICU will be pre-screened according to inclusion and exclusion criteria prior to informed consent using available clinical data.

Informed consent, screening and randomisation procedures should be completed within 72 hours from the time of admission to ICU and within 48 hours from starting continuous sedation. Eligible study subjects requiring light to moderate sedation (Richmond Agitation-Sedation Scale [RASS] = 0 to -3) will be randomised to either continue on propofol or switch to dexmedetomidine. Patients should not have received any other continuously or regularly administered sedative agent than propofol during the last 12 hours except for opioid analgesics. Study treatments will be titrated to achieve an individually targeted sedation range determined on a daily basis. Rescue treatment (i.e. midazolam boli) may be given if needed to achieve the target depth of sedation. Continued need for sedation will be assessed at a daily sedation stop, conducted at the same time each day. First sedation stop may be 12-36 hours from randomisation, depending on the time of day the study subject is randomised. The duration of study treatment is limited to a maximum of 14 days from randomisation. Following withdrawal of sedation, study subjects will be monitored for 48 hours and contacted by telephone 31 and 45 days after randomisation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Continuous Sedation in Initially Sedated Adults in ICU
Intervention  ICMJE
  • Drug: Dexmedetomidine
    Continuous infusion
  • Drug: Propofol
    Continuous infusion
Study Arms  ICMJE
  • Experimental: 1
    Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
  • Active Comparator: 2
    Propofol
    Intervention: Drug: Propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2007)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 α2 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   Germany,   Netherlands,   Russian Federation,   Switzerland,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479661
Other Study ID Numbers  ICMJE 3005012
EudraCT 2006-006030-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kati Kaijasilta, Orion corporation, Orion Pharma, Clinical R&D
Study Sponsor  ICMJE Orion Corporation, Orion Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Esko Ruokonen, MD Kuopio University Hospital
Study Director: Kati Kaijasilta, MSc (Pharm) Orion Corporation, Orion Pharma
PRS Account Orion Corporation, Orion Pharma
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP