Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients (NICEWEAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01707680
Recruitment Status : Unknown
Verified November 2012 by Orion Corporation, Orion Pharma.
Recruitment status was:  Recruiting
First Posted : October 16, 2012
Last Update Posted : November 2, 2012
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma

Brief Summary:
The purpose of this study is to determine whether the use of different sedatives affect the weaning process from mechanical ventilation in intensive care patients.

Condition or disease
Critical Illness

Detailed Description:

Traditionally patients with ongoing mechanical ventilation have been sedated to assure absence of pain, anxiety and to provide comfort. Unfortunately this approach might have negative consequences such as prolonged time for mechanical ventilation, length of stay in the ICU and hospital.

In this study, the investigators would like to investigate (in an exploratory way due to the non-interventional setup) whether weaning from mechanical ventilation will be affected by the choice of sedatives - including dexmedetomidine, midazolam and propofol. This study also aims at investigating how the choice of primary sedative will affect delirium/anxiety, need of other medications (sedatives, analgesics, anti-psychotics), quality of life after ICU and the presence of Post-Traumatic Stress Disorder. In addition, the investigators aim at receiving information from the caregivers on their ICU experience, as recent data imply that not only the ICU patient but also the caregiver suffer from PTSD after the ICU stay.

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients
Study Start Date : June 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Here, patients to be included are those being sedated with dexmedetomidine as primary sedative.
Here, patients to be included are those being sedated with propofol as primary sedative.
Here, patients to be included are those being sedated with midazolam as primary sedative

Primary Outcome Measures :
  1. The time point from when the patient is considered "fit for weaning" to the actual time point for extubation [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Time-point for patient being considered "fit for extubation" [ Time Frame: 30 days ]
  2. Total time in mechanical ventilation [ Time Frame: 30 days ]
  3. Extubation failure (re-intubation within 24 hours) [ Time Frame: 24 hours ]
  4. Anxiety/delirium assessments [ Time Frame: 30 days ]
    RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate

  5. Length of ICU stay (actual time of discharge) [ Time Frame: 30 days ]
  6. QoL (15D) [ Time Frame: 2-4 months post-ICU discharge ]
  7. Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire [ Time Frame: 2-4 months post-ICU discharge ]
    This assessment will be offered to the ICU patients but also to their caregivers.

  8. Total duration of sedation [ Time Frame: 30 days ]
  9. Number of days using opioids [ Time Frame: 30 days ]
  10. Number of days using antipsychotic/neuroleptic drugs [ Time Frame: 30 days ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult general intensive care patients Need of mechanical ventilation >24 hours Need of light to moderate sedation

Inclusion Criteria:

  • Admitted to a general ICU ward
  • ≥ 18years
  • Intubated and mechanically ventilated for at least 24 hours
  • Need of light to moderate sedation (corresponding to RASS 0 - (-3) or MAAS 2-3)
  • Sedated with dexmedetomidine, midazolam and/or propofol
  • Good knowledge in Swedish language
  • Signed informed consent

Exclusion criteria:

  • Lack of fulfilling prescribed sedation regime
  • Estimated high risk of death during the study period, according to investigator (roughly equal to estimated mortality rate (EMR) > 80% )
  • Tracheotomy
  • Change in sedative drugs since the "fit for weaning" time point
  • Use of other alpha-2 agonists (clonidine) during ICU stay
  • Positive pregnancy test or currently lactating/ known pregnancy or lactation
  • Participation in other study involving use of a pharmacologically active compound
  • Patients with limitations in therapy
  • Otherwise unable to fulfill the study, according to investigator's opinion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01707680

Contact: Barbro Holm, PhD +46-86236438
Contact: Hakan Klewstigh +46-8-6236451

Danderyds Hospital Anestesi- och intensivvårdskliniken Recruiting
Danderyd, Sweden, SE18288
Contact: Carl-Johan Wickerts, MD    +4612357963   
Principal Investigator: Carl-Johan Wickerts, MD PhD         
Sub-Investigator: Silvia Lindqvist Nunes, MD PhD         
Capio S:t Goran Hospital, Anestesikliniken Recruiting
Stockholm, Sweden, SE11281
Contact: Hans Blomqvist, MD PhD    +46762734060   
Principal Investigator: Hans Blomqvist, MD PhD         
Örebro University Hospital, Anestesi- och intensivvårdskliniken Recruiting
Örebro, Sweden, SE70185
Contact: Lars Berggren, MD PhD    +4619602 03 14   
Principal Investigator: Lars Berggren, Md PhD         
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Principal Investigator: Carl-Johan Wickerts, MD Danderyds Hospital, Danderyd, Sweden

Responsible Party: Orion Corporation, Orion Pharma Identifier: NCT01707680     History of Changes
Other Study ID Numbers: 3005022
Dnr 2012/628-31/4 ( Other Identifier: Ethical Review Board, Stockholm Region )
First Posted: October 16, 2012    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012

Keywords provided by Orion Corporation, Orion Pharma:
mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents