Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients

• ClinicalTrials.gov Identifier: NCT00466492
• Recruitment Status: Completed
• First Posted: April 27, 2007
• Last Update Posted: March 19, 2010
• Sponsor: Odense University Hospital
• Information provided by: Odense University Hospital

Tracking Information

• First Submitted Date: April 26, 2007
• First Posted Date: April 27, 2007
• Last Update Posted Date: March 19, 2010
• Study Start Date: April 2007
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 18, 2010): Time receiving mechanical ventilation, total intensive care and hospital length of stay.
• Original Primary Outcome Measures (submitted: April 26, 2007): • Time receiving mechanical ventilation, intensive care and hospital length of stay.
• Current Secondary Outcome Measures (submitted: March 18, 2010): The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses [ Time Frame: VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay ]
• Original Secondary Outcome Measures (submitted: April 26, 2007): • The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
• Official Title: Advantages and Disadvantages of Long Term Sedation in ICU Patients
• Brief Summary: The purpose of the study is to determine whether sedation of the critical ill patient prolongs the time receiving mechanical ventilation.

Detailed Description

The golden standard is to sedate critical ill patients receiving mechanical ventilation with daily wake up trials. This is shown to reduce the time receiving mechanical ventilation compared to no wake up trials.

We would like to study whether no sedation but only analgesics administered as bolus doses, reduce the time receiving mechanical ventilation. The study is planned as a randomised prospective study, not blinded. The control group is patients receiving sedation with daily wake up trials. The intervention group is not sedated, but receives bolus doses of analgesics (morphine). The endpoint is the time spend receiving mechanical ventilation, lengths of stay on the intensive care unit, and total lengths of stay on the hospital.

We also examine the frequency of ventilator associated pneumonia and CT scans of cerebrum. Also we would like to examine the long term psychological effects of sedation, we plan to send some of the patients to a post traumatic stress screening. The effect on the next of kin we plan to study with a questionnaire. As a last thing we would like to study the workload on the nurses.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Critical Illness
• Length of Stay
• Respiration, Artificial
• Intensive Care Units

Intervention

Procedure: Sedation or no sedation during mechanical ventilation

No sedation to critically ill patients

Other Names:

• Awake
• intensive care
• Denmark
• Mechanical ventilation

Study Arms

No sedatation intervention

The intervention group is the normal care in our institution, the control group is the golden standard

Intervention: Procedure: Sedation or no sedation during mechanical ventilation

Publications *

• Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
• Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.
• Schweickert WD, Gehlbach BK, Pohlman AS, Hall JB, Kress JP. Daily interruption of sedative infusions and complications of critical illness in mechanically ventilated patients. Crit Care Med. 2004 Jun;32(6):1272-6. doi: 10.1097/01.ccm.0000127263.54807.79.
• Strom T, Stylsvig M, Toft P. Long-term psychological effects of a no-sedation protocol in critically ill patients. Crit Care. 2011;15(6):R293. doi: 10.1186/cc10586. Epub 2011 Dec 13.
• Strom T, Johansen RR, Prahl JO, Toft P. Sedation and renal impairment in critically ill patients: a post hoc analysis of a randomized trial. Crit Care. 2011;15(3):R119. doi: 10.1186/cc10218. Epub 2011 May 4.
• Strom T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. Lancet. 2010 Feb 6;375(9713):475-80. doi: 10.1016/S0140-6736(09)62072-9. Epub 2010 Jan 29.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 26, 2007): 140
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2009
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Intubated receiving mechanical ventilation
• Expected to remain intubated more than 24 hours
• Over 18 years

Exclusion Criteria:

• Raised intracranial pressure
• Pregnant
• Treatment with muscle relaxants

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT00466492
• Other Study ID Numbers: 22-6-06
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Thomas Strøm, Anaesthesiologic-intensive unit, Odens University Hospital
• Original Responsible Party: Not Provided
• Current Study Sponsor: Odense University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Palle Toft, Professor; Institute of Clinical Research

• PRS Account: Odense University Hospital
• Verification Date: June 2009