Non-interventional Comparison of Sedatives on Weaning Fro... | NCT01707680

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

NCT01707680

Sponsor

Orion Corporation, Orion Pharma

Status

Terminated

Last Update Posted

Sep 6, 2019Actual

Enrollment

155Actual

Phase

Not provided

Conditions

Critical Illness

Interventions

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Dnr 2012/628-31/4	Other Identifier	Ethical Review Board, Stockholm Region

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Halted due to slow recruitment

Expanded Access Info

Start Date

Jun 1, 2012Actual

Primary Completion Date

Nov 1, 2015Actual

Completion Date

Nov 1, 2015Actual

First Submitted Date

Oct 12, 2012

First Submission Date that Met QC Criteria

Oct 15, 2012

First Posted Date

Oct 16, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2019

Last Update Posted Date

Sep 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

155Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SOC	Other	Patient are given standard of care	Dexmedetomidine Midazolam Propofol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The time point from when the patient is considered "fit for weaning" to the actual time point for extubation		30 days

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carl-Johan Wickerts, MD	Danderyds Hospital, Danderyd, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Danderyds Hospital Anestesi- och intensivvårdskliniken		Danderyd		SE18288	Sweden
Örebro University Hospital, Anestesi- och intensivvårdskliniken

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29502195	Result	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms