Phase 4
N=36
Study of Sedative Medications in Patients With Severe Infection and Respiratory Failure
Sepsis · Respiratory Failure · Agitation
Bottom Line
View on ClinicalTrials.gov: NCT02203019 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Duration of Mechanical Ventilation — 5; 3 days — p=0.107
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Propofol (Drug); Dexmedetomidine (Drug); Fentanyl (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Texas Tech University Health Sciences Center
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Mechanical Ventilation |
5; 3 | 0.107 |
| SECONDARY Duration of MICU Stay |
6; 5 | 0.260 |
| SECONDARY Duration of Vasopressor Support |
0; 2 | 0.376 |
| SECONDARY Mortality |
8; 9 | 0.739 |
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
Data sourced from ClinicalTrials.gov (NCT02203019). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.