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Sedation in the Intensive Care Unit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by University Hospital, Geneva.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00221520
First received: September 15, 2005
Last updated: January 9, 2007
Last verified: January 2007

September 15, 2005
January 9, 2007
February 2003
Not Provided
  • Post-traumatic stress disorders (PTSD)
  • Anxiety
  • Depression
Same as current
Complete list of historical versions of study NCT00221520 on ClinicalTrials.gov Archive Site
  • Time to discharge from the Intensive Care Unit
  • Time to separation from mechanical ventilation
  • Rates of pulmonary and extra-pulmonary complications Hospital length of stay
Same as current
Not Provided
Not Provided
 
Sedation in the Intensive Care Unit
Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients

High-risk critically ill patients often require mechanical ventilation either to primarily support the respiratory function or when the ventilation is insufficient to maintain adequate gas exchanges as a result of other organ impairment. In order to tolerate this aggressive mechanical support, enhance patient synchrony with the ventilator, and relieve pain and anxiety, analgesia and sedation are provided. It is suggested that an inappropriate use of sedation and analgesia may prolong the duration of mechanical ventilation and increase the risk of specific adverse outcomes such as ventilator associated pneumonia. Despite the widespread use of sedation, little information is available concerning the effect of varying the level of sedation on patients' subsequent mental health. We designed a randomized controlled trial to investigate the efficacy of sedation with the goal of maintaining the patient cooperative and interactive compared to the administration of sedation with the goal of maintaining the patient sedated. The first goal will be achieved by a discontinuous injection of a sedative, while the second goal will be achieved by a continuous infusion of the same sedative. In both groups pain relief will be provided in the same fashion with equal endpoints on a pain scoring scale. Our primary aim is to investigate whether differences in the occurrence of post-traumatic stress disorders (PTSD), anxiety, and depression are related to the choice of sedation-analgesia strategies. Secondary endpoints include the length of ICU stay, as indicated by the time to discharge from the ICU, the time to separation from mechanical ventilation, the rates of pulmonary and extra-pulmonary complications, and hospital length of stay. These endpoints will be compared between the two groups.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Critical Illness
  • Respiratory Failure
Drug: midazolam with 2 different levels of sedation scores
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
126
January 2007
Not Provided

Inclusion Criteria:

  • Critically ill patients requiring mechanical ventilation

Exclusion Criteria:

  • Neurological conditions or neuromuscular disease
  • Chronic renal failure, liver failure
  • Allergy to benzodiazepines or morphine
  • Drug overdose
  • Pregnancy
  • Non-cooperative
  • Treatment with HIV protease inhibitors or erythromycin
  • Refusal of consent
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00221520
3200-068312, 2002DR2266
Not Provided
Not Provided
University Hospital, Geneva
Swiss National Science Foundation
Principal Investigator: Miriam M Treggiari, MD University Hospital, Geneva
University Hospital, Geneva
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP