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

Orion Pharma

Status: Terminated

Conditions: Critical Illness

Treatments: Other: SOC

Study type: Observational

Funder types: Industry

Identifiers

NCT01707680

3005022

Dnr 2012/628-31/4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

155 participants in 3 patient groups

Dexmedetomidine

Description:

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

Treatment:

Other: SOC

Propofol

Description:

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

Treatment:

Other: SOC

Midazolam

Description:

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

Treatment:

Other: SOC