NCT00824239

Brief Summary

Sedation is very important in critical care. Critically ill patients are submitted to many stressor factors that have potential to affect longterm outcomes. However, oversedation is associated with increased morbidity, including increased time of mechanical ventilation and ICU stay and longterm psychological complications. Daily interruption of sedation is associated with less time under mechanical ventilation and less posttraumatic stress disorder. Intermittent sedation, when compared with continuous sedation, is also associated with decreased time of mechanical ventilation. The aim of this study is to compare intermittent sedation with daily interruption. Our primary endpoint is free-days of mechanical ventilation in 28 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2008

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 11, 2012

Status Verified

June 1, 2012

Enrollment Period

3.2 years

First QC Date

January 15, 2009

Last Update Submit

June 8, 2012

Conditions

Mechanical Ventilation

Keywords

critical caresedationMechanically ventilated patients

Outcome Measures

Primary Outcomes (1)

  • Ventilator free-days

    28 days

Secondary Outcomes (6)

  • Mortality

    28 days

  • Time of stay

    ICU, hospitalar

  • Self-extubation

    28 days

  • Reintubation

    2 days after extubation

  • Incidence of posttraumatic stress disorder

    6 months

  • +1 more secondary outcomes

Study Arms (2)

1. Intermittent sedation

ACTIVE COMPARATOR
Procedure: Intermittent sedation

2. Daily interruption of sedation

ACTIVE COMPARATOR
Procedure: Daily interruption of sedation

Interventions

Intermittent sedationPROCEDURE

Patients under intermittent sedation stay without any continuous sedation since intubation and/or admission but receive analgesics as needed and sedatives only when agitated (SAS of 5 or more).

Also known as: Fentanyl, midazolam, propofol
1. Intermittent sedation
Daily interruption of sedationPROCEDURE

Patients under daily interruption of sedation stay on continuous sedation with midazolam and fentanyl and are submitted to a daily interruption of sedation to a neurological evaluation until they reach a SAS of 4 or more, then continuous sedation is re-started in the half previous dosage.

Also known as: Fentanyl, midazolam, propofol
2. Daily interruption of sedation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients under mechanical ventilation with less of 24 hours and a expectative of stay intubated for more than 24 hours

You may not qualify if:

  • Intubation secondary to a neurological cause
  • Pregnant women
  • Severe asthma or COPD decompensation
  • Palliative care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clinicas - University of Sao Paulo

São Paulo, São Paulo, 05403000, Brazil

Location

Related Publications (1)

  • Nassar Junior AP, Park M. Daily sedative interruption versus intermittent sedation in mechanically ventilated critically ill patients: a randomized trial. Ann Intensive Care. 2014 May 6;4:14. doi: 10.1186/2110-5820-4-14. eCollection 2014.

    PMID: 24900938DERIVED

MeSH Terms

Interventions

FentanylMidazolamPropofol

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Antonio Paulo Nassar Junior, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Marcelo Park, PhD

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Antonio Paulo Nassar Junior

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

September 1, 2008

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

June 11, 2012

Record last verified: 2012-06

Locations

BR(1)