Skip to main content
OpenTrials
Completed

NCT Number: NCT00298493

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sedation management strategy

Procedure

Primary outcomes

  1. Duration of Mechanical Ventilation

  2. ICU and Hospital Lengths of stay

Secondary outcomes

  1. Adverse events

  2. Patient Recall

  3. Caregiver workload

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2004
First posted
Mar 2, 2006
Registry last updated
Mar 2, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.