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

Critical Illness Clinical Trial

— NICEWEAN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01707680
• Other study ID #: 3005022
• Secondary ID: Dnr 2012/628-31/
• Status: Terminated
• Start date: June 1, 2012
• Est. completion date: November 1, 2015

Study information

• Verified date: September 2019
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 155
• Est. completion date: November 1, 2015
• Est. primary completion date: November 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• SOC
Patient are given standard of care

Locations

Country	Name	City	State
Sweden	Danderyds Hospital Anestesi- och intensivvårdskliniken	Danderyd
Sweden	Örebro University Hospital, Anestesi- och intensivvårdskliniken	Örebro
Sweden	Capio S:t Goran Hospital, Anestesikliniken	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Nunes SL, Forsberg S, Blomqvist H, Berggren L, Sörberg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time point from when the patient is considered "fit for weaning" to the actual time point for extubation		30 days
Secondary	Time-point for patient being considered "fit for extubation"		30 days
Secondary	Total time in mechanical ventilation		30 days
Secondary	Extubation failure (re-intubation within 24 hours)		24 hours
Secondary	Anxiety/delirium assessments	RASS/MAAS sedation scales and ICDSC/CAM-ICU delirium assessments methods are used, as appropriate	30 days
Secondary	Length of ICU stay (actual time of discharge)		30 days
Secondary	QoL (15D)		2-4 months post-ICU discharge
Secondary	Post-Traumatic Stress Disorder assessment - PTSS14 questionnaire	This assessment will be offered to the ICU patients but also to their caregivers.	2-4 months post-ICU discharge
Secondary	Total duration of sedation		30 days
Secondary	Number of days using opioids		30 days
Secondary	Number of days using antipsychotic/neuroleptic drugs		30 days