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

NCT01707680 | Terminated

• 2 other identifiers: 3005022Dnr 2012/628-31/4
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 3

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.

Conditions

Critical Illness

Keywords

weaning; mechanical ventilation; dexmedetomidine; propofol; midazolam

Outcome Measures

Primary Outcomes (1)

• The time point from when the patient is considered "fit for weaning" to the actual time point for extubation

  30 days

Secondary Outcomes (10)

• Time-point for patient being considered "fit for extubation"

  30 days

• Total time in mechanical ventilation

  30 days

• Extubation failure (re-intubation within 24 hours)

  24 hours

• Anxiety/delirium assessments

  30 days

• Length of ICU stay (actual time of discharge)

  30 days

Study Arms (3)

Dexmedetomidine

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

Other: SOC

Propofol

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

Other: SOC

Midazolam

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

Other: SOC

Interventions

SOC OTHER

Patient are given standard of care

Dexmedetomidine; Midazolam; Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult general intensive care patients Need of mechanical ventilation \>24 hours Need of light to moderate sedation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (3)

Danderyds Hospital Anestesi- och intensivvårdskliniken

Danderyd, SE18288, Sweden

Location

Örebro University Hospital, Anestesi- och intensivvårdskliniken

Örebro, SE70185, Sweden

Location

Capio S:t Goran Hospital, Anestesikliniken

Stockholm, SE11281, Sweden

Location

Related Publications (1)

• Nunes SL, Forsberg S, Blomqvist H, Berggren L, Sorberg M, Sarapohja T, Wickerts CJ. Effect of Sedation Regimen on Weaning from Mechanical Ventilation in the Intensive Care Unit. Clin Drug Investig. 2018 Jun;38(6):535-543. doi: 10.1007/s40261-018-0636-2.

  PMID: 29502195 RESULT

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carl-Johan Wickerts, MD

  Danderyds Hospital, Danderyd, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: June 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: September 6, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)