Critical IllnessPhase 2NCT00298493
Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol
A Phase 2 study testing Sedation management strategy in people with Critical Illness and Mechanical Ventilation, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation
- What is being tested?
- Sedation management strategy
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2001to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Critical Illness, Mechanical Ventilation
- Being tested
- Sedation management strategy
- Keywords
- ICU, Sedation strategies, Daily sedative interruption, Sedation protocols
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedation management strategyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Mechanical Ventilation
ICU and Hospital Lengths of stay
Secondary outcomes (3)
Adverse events
Patient Recall
Caregiver workload
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2006 (estimated)
- Study startFeb 2001
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Investigators
- Sangeeta Mehta, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298493
- Sponsor's protocol ID
- MSH REB#00-0032-A
- Status last verified
- Feb 2006
- First submitted
- 28 Feb 2006
- Last updated
- 2 Mar 2006
- Results posted
- No
Publications
Mehta S, Burry L, Martinez-Motta JC, Stewart TE, Hallett D, McDonald E, Clarke F, Macdonald R, Granton J, Matte A, Wong C, Suri A, Cook DJ; Canadian Critical Care Trials Group. A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: a pilot trial. Crit Care Med. 2008 Jul;36(7):2092-9. doi: 10.1097/CCM.0b013e31817bff85.
PubMed 18552687
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Daily Sedative Interruption in Critically Ill Patients Being Managed With a Sedation Protocol - A Pilot Study
- ClinicalTrials.gov ID
- NCT00298493
- Acronym / sponsor ID
- MSH REB#00-0032-A
- Conditions
- Critical Illness, Mechanical Ventilation
- Keywords
- ICU, Sedation strategies, Daily sedative interruption, Sedation protocols
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Feb 2001
- Study completion
- Sep 2004
- First posted
- 2 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedation management strategy | Procedure or surgery | – |
Primary outcome
Duration of Mechanical Ventilation
ICU and Hospital Lengths of stay
3 secondary outcomes
Adverse events
Patient Recall
Caregiver workload
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2006.
- Derived from this study: PubMed 18552687Mehta S, Burry L, Martinez-Motta JC, Stewart TE, Hallett D, McDonald E, Clarke F, Macdonald R, Granton J, Matte A, Wong C, Suri A, Cook DJ; Canadian Critical Care Trials Group. A randomized trial of daily awakening in critically ill patients managed with a sedation protocol: a pilot trial. Crit Care Med. 2008 Jul;36(7):2092-9. doi: 10.1097/CCM.0b013e31817bff85.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeeta Mehta, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sedation management strategy in people with Critical Illness and Mechanical Ventilation, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Mechanical Ventilation. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00298493, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2006.