Sedation in the Intensive Care Unit

Critical Illness Clinical Trial

Official title:

Trial on The Efficacy of Sedation in Mechanically Ventilated Critically Ill Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00221520
• Other study ID #: 3200-068312
• Secondary ID: 2002DR2266
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 15, 2005
• Last updated: January 9, 2007
• Start date: February 2003
• Est. completion date: January 2007

Study information

• Verified date: January 2007
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• midazolam with 2 different levels of sedation scores

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-traumatic stress disorders (PTSD)
Primary	Anxiety
Primary	Depression
Secondary	Time to discharge from the Intensive Care Unit
Secondary	Time to separation from mechanical ventilation
Secondary	Rates of pulmonary and extra-pulmonary complications Hospital length of stay