- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00298493
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
Conditions
Intervention / Treatment
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:
- 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.
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Critical Illness
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States
-
McMaster UniversityLondon Health Sciences Centre; McMaster Children's Hospital; Canadian Critical...CompletedPediatric Critical IllnessCanada
-
Boston Children's HospitalCompleted
-
St Helens & Knowsley Teaching Hospitals NHS TrustManchester University NHS Foundation TrustCompleted
-
Sándor BeniczkyUniversity of Aarhus; Danish Council for Independent Research; Søster og Verner...CompletedCritical Illness Myopathy | Myopathy Critical IllnessDenmark
-
Hospital de Clinicas de Porto AlegreUnknownCritical Illness PolyneuropathiesBrazil
-
Peking Union Medical College HospitalBaxter Healthcare CorporationUnknownNutrition Therapy for Critical Illness
-
Assistance Publique - Hôpitaux de ParisRecruitingCritical Illness Related Corticosteroids InsufficiencyFrance
-
Yuzuncu Yıl UniversityKahramanmaras Sutcu Imam University; Izmir Ataturk Training and Research HospitalCompleted
Clinical Trials on Sedation management strategy
-
University of MichiganMedical University of South Carolina; University of Pennsylvania; National Institute... and other collaboratorsRecruitingBrain Injuries, TraumaticUnited States, Canada
-
Melbourne HealthAbbott; University of Melbourne; Australian College of Critical Care NursesCompletedRespiration DisordersAustralia
-
The Hospital for Sick ChildrenUnknownCongenital Heart DiseaseCanada
-
University Hospital, LilleRecruiting
-
University of GlasgowBrain Injury Rehabilitation TrustWithdrawnAcquired Brain Injury
-
Allegheny Singer Research Institute (also known...Active, not recruitingLung CancerUnited States
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI)CompletedLung Diseases | Respiratory Insufficiency | Respiratory Distress Syndrome, NewbornUnited States
-
Kajsa JohanssonThe Research Council of South East Sweden (FORSS)RecruitingPain | Anxiety | Communication | Pain, Chronic | Self Efficacy | Referral and Consultation | Patient-Centered Care | Pain Acute | Worry | Sickness Absence | Physical Activity Level | Illness PerceptionsSweden
-
Vanderbilt University Medical CenterCheetah Medical Inc.TerminatedHemodynamic Monitoring | Vascular Resistance | Cardiac Event | Fluid Responsiveness | Fluid Management | Inotropy | Perioperative Cardiac Risk | Hemodynamic ManagementUnited States
-
Li YangWest China HospitalUnknown