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

NCT ID: NCT01707680

Last Updated: 2019-09-06

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 155 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2015-11-01

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.

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.

Conditions

Critical Illness

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Dexmedetomidine

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

SOC

Intervention Type: OTHER

Patient are given standard of care

Propofol

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

SOC

Intervention Type: OTHER

Patient are given standard of care

Midazolam

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

SOC

Intervention Type: OTHER

Patient are given standard of care

Interventions

SOC

Patient are given standard of care

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl-Johan Wickerts, MD

Role: PRINCIPAL_INVESTIGATOR

Danderyds Hospital, Danderyd, Sweden

Locations

Danderyds Hospital Anestesi- och intensivvårdskliniken

Danderyd, , Sweden

Örebro University Hospital, Anestesi- och intensivvårdskliniken

Örebro, , Sweden

Capio S:t Goran Hospital, Anestesikliniken

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: RESULT

PMID: 29502195 (View on PubMed)

Other Identifiers

Dnr 2012/628-31/4

Identifier Type: OTHER

Identifier Source: secondary_id

3005022

Identifier Type: -

Identifier Source: org_study_id