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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by Orion Corporation, Orion Pharma
Sponsor:
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01707680
First received: October 12, 2012
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Non-interventional Comparison of Sedatives on Weaning From Mechanical Ventilation in Intensive Care Patients

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • The time point from when the patient is considered "fit for weaning" to the actual time point for extubation [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-point for patient being considered "fit for extubation" [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Total time in mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Extubation failure (re-intubation within 24 hours) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Anxiety/delirium assessments [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate

  • Length of ICU stay (actual time of discharge) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • QoL (15D) [ Time Frame: 2-4 months post-ICU discharge ] [ Designated as safety issue: No ]
  • Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire [ Time Frame: 2-4 months post-ICU discharge ] [ Designated as safety issue: No ]
    This assessment will be offered to the ICU patients but also to their caregivers.

  • Total duration of sedation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of days using opioids [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Number of days using antipsychotic/neuroleptic drugs [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: June 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Dexmedetomidine
Here, patients to be included are those being sedated with dexmedetomidine as primary sedative.
Propofol
Here, patients to be included are those being sedated with propofol as primary sedative.
Midazolam
Here, patients to be included are those being sedated with midazolam as primary sedative

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707680

Contacts
Contact: Barbro Holm, PhD +46-86236438 Barbro.Holm@orionpharma.com
Contact: Hakan Klewstigh +46-8-6236451 Hakan.Klewstigh@orionpharma.com

Locations
Sweden
Danderyds Hospital Anestesi- och intensivvårdskliniken Recruiting
Danderyd, Sweden, SE18288
Contact: Carl-Johan Wickerts, MD    +4612357963    carl-johan.wickerts@ds.se   
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    hans.blomqvist@capio.se   
Principal Investigator: Hans Blomqvist, MD PhD         
Örebro University Hospital, Anestesi- och intensivvårdskliniken Recruiting
Örebro, Sweden, SE70185
Contact: Lars Berggren, MD PhD    +4619602 03 14    lars.berggren@orebroll.se   
Principal Investigator: Lars Berggren, Md PhD         
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Carl-Johan Wickerts, MD Danderyds Hospital, Danderyd, Sweden
  More Information

No publications provided

Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01707680     History of Changes
Other Study ID Numbers: 3005022, Dnr 2012/628-31/4
Study First Received: October 12, 2012
Last Updated: November 1, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Orion Corporation, Orion Pharma:
weaning
mechanical ventilation
dexmedetomidine
propofol
midazolam

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on September 30, 2014