Study of Sedative Medications in Patients With Severe Infection and Respiratory Failure
Condition: Sepsis; Respiratory Failure; Agitation
MeSH terms: Sepsis; Respiratory Insufficiency
Intervention: Propofol; Dexmedetomidine; Fentanyl
Intervention description: Propofol will be administered for sedation in mechanically ventilated patients with sepsis.; Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis.; Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention "of interest".
Intervention MeSH terms: Fentanyl; Dexmedetomidine; Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Dexmedetomidine; Propofol; Sepsis; Mechanical Ventilation; Respiratory Failure

Summary:

      Patients with infections in their blood often become very sick. These patients are usually
      put in an intensive care unit for careful observation and treatment. These patients may
      develop a low blood pressure, lung failure, and kidney failure. When these problems develop,
      care becomes quite complicated. Patients with lung failure often need help with a breathing
      machine to make certain that the breathing is adequate. The machine helps keep the oxygen
      level high enough for healthy tissues. When patients are placed on the machine for breathing
      they require a tube to be placed into lungs. This can be quite uncomfortable. These patients
      need sedation to help them tolerate the uncomfortable breathing tube and other parts of their
      routine necessary care. This study will compare two drugs (dexmedetomidine and propofol)
      which are frequently used for sedation in intensive care patients. Clinical studies suggest
      that these drugs are both effective and safe. The main question is whether or not one of the
      drugs is better in a patient with a blood infection. This study will try to determine that.
      Our main goal is to see whether or not patients on one particular drug come off the breathing
      machine faster than patients on the other drug. These drugs are not experimental drugs and
      are approved by the Food and Drug Administration. There is no placebo drug being used in this
      study. All patients in this study will receive the best possible care based on their medical
      condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women 18-89 years old

          -  with the diagnosis of sepsis (as specified below) within the previous 24 hours

          -  who require mechanical ventilation, and

          -  provide informed consent either personally or by an authorized representative.

        Exclusion Criteria:

          -  Patients with documented allergies to propofol, dexmedetomidine, fentanyl, eggs or egg
             products, or soy or soy products.

          -  A heart rate less than 50 beats/minute or grade 2 or 3 AV heart block

          -  Mean arterial pressure less than 55 mmHg despite appropriate fluid resuscitation and
             vasopressor support.

          -  Current triglyceride level > 400 mg/dl