Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol

February 28, 2006 updated by: Mount Sinai Hospital, Canada

A Randomized Trial of Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol - A Pilot Study

All critically ill, mechanically ventilated patients in the Intensive Care Unit receive medications to relieve pain and anxiety. However, accumulation of these medications can be associated with serious complications, most notably longer time on the breathing machine and in the ICU. Two strategies have been shown to dramatically improve patient outcomes: nurse-directed protocols for giving sedation, and daily interruption of sedation. However, these strategies have not been widely adopted, because of physicians' concerns, and because it is unclear which strategy is better. Given that patient outcome is improved with either of these strategies, the fundamental question that arises is whether patients managed with a combination of two strategies which both reduce drug accumulation (protocolized sedation and daily interruption) have an even better outcome than patients managed with only one of them (protocolized sedation). We propose a multicenter study in which 700 critically ill, mechanically ventilated patients will have their sedation managed with protocolized sedation alone, or both strategies. Both groups of patients will have the following recorded: ICU and hospital lengths of stay, mortality, total sedative drug use, ICU human resources used, side effects and recall of their ICU stay. The results of this large multi-center trial will help to inform best practice with regard to sedation management of critically ill patients in Canada and elsewhere. In addition, reducing ICU stay could be economically attractive, as the cost of an ICU day in Canada is approximately $3000.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. age>18 years
  2. Mechanically ventilated, with anticipated need for MV ≥ 48 hours
  3. ICU team has decided to initiate continuous sedative/analgesic infusion(s)
  4. informed consent.

Exclusion Criteria:

  1. Admission after resuscitation from cardiac arrest
  2. Traumatic brain injury
  3. Currently receiving neuromuscular blocking agents
  4. Allergy to any of the study medications
  5. History of alcohol, sedative or analgesic abuse
  6. History of psychiatric illness
  7. Acute or chronic neurologic dysfunction
  8. Administration of sedatives for >24 hr,
  9. Lack of commitment to aggressive treatment
  10. Current enrollment in a related trial
  11. Previous enrollment in this trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Duration of Mechanical Ventilation
ICU and Hospital Lengths of stay

Secondary Outcome Measures

Outcome Measure
Adverse events
Patient Recall
Caregiver workload

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sangeeta Mehta, MD, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Completion

September 1, 2004

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (Estimate)

March 2, 2006

Study Record Updates

Last Update Posted (Estimate)

March 2, 2006

Last Update Submitted That Met QC Criteria

February 28, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Other Study ID Numbers

  • MSH REB#00-0032-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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