Clinical trial NCT00466492: Advantages and Disadvantages of Long Term Sedation in Intensive Care Unit Patients
Official title: Advantages and Disadvantages of Long Term Sedation in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Length of Stay
Respiration, Artificial
Intensive Care Units
Keywords: Drug Administration Schedule
Intensive Care Units
Length of Stay
Respiration, Artificial
Stress Disorders, Post-Traumatic/etiology/*psychology
Critical Illness/*psychology
Pneumonia/prevention & control
Hypnotics and Sedatives/*administration & dosage
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time receiving mechanical ventilation, total intensive care and hospital length of stay.
Secondary outcomes:
measure: The frequency of VAP, CTC. The amount of Post Traumatic Stress after 6 month. The patients families experience. The workload on the nurses
timeFrame: VAP and CTC during hospital stay. PTSD 1-2 years after the primary stay
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Anaesthesiologic-intensive Care Department, Odense University Hospital
Study officials:
affiliation: Institute of Clinical Research
name: Palle Toft, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.