Recruitment

Recruitment Status
Completed
Estimated Enrollment
326

Inclusion Criterias

who require mechanical ventilation, and
provide informed consent either personally or by an authorized representative.
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.
with the diagnosis of sepsis (as specified below) within the previous 24 hours
Men and women 18-89 years old

Exclusion Criterias

Current triglyceride level > 400 mg/dl
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
...
Current triglyceride level > 400 mg/dl
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.

Summary

Conditions
  • Agitation
  • Respiratory Failure
  • Sepsis
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 89 years
Gender
Both males and females

Description

Patients admitted to the MICU with acute respiratory care and possible sepsis will be evaluated and managed by the internal medicine MICU team. This team includes faculty members, pulmonary fellows, and internal medicine residents. These physicians will make all the decisions regarding the initial m...

Patients admitted to the MICU with acute respiratory care and possible sepsis will be evaluated and managed by the internal medicine MICU team. This team includes faculty members, pulmonary fellows, and internal medicine residents. These physicians will make all the decisions regarding the initial management of the patient. The admitting team will be approached by the study investigators to solicit their support for the recruitment of the patient into the study. During some periods of time the study investigators will be directly involved in the patient care. The general approach to managing patients with sepsis includes blood cultures, serum lactate levels, and empiric antibiotics. Other cultures from the respiratory tract, urinary tract, and other sites are also obtained as indicated. Empiric antibiotic choices will be based on the most likely source of infection. Patient will receive fluid administration and vasopressors to maintain mean arterial pressure blood pressures greater than or equal to 60 mmHg. Mechanical ventilation support will follow ARDS network guidelines. In general patients will be on an assist-control mode, a low tidal volume (6 mm/kg ideal body weight), and a FiO2 adequate to maintain O2 saturations greater than equal to 90%. PEEP levels will be based on the FiO2 using ARDS network recommendations. The ventilator management goal is to have the lowest possible plateau pressure and lowest FiO2 possible to maintain adequate ventilation and oxygenation. Fentanyl will be routinely ordered for analgesia. Per current UMC policy, initial fentanyl boluses will be given at 50mcg IV every 2 hours as needed to keep pain level less than 4/10. At the discretion of the provider, a fentanyl drip may be administered if intermittent fentanyl does not achieve adequate analgesia. If a fentanyl drip is initiated, the drip will have a range of 25-200 mcg/hour to achieve a pain level of less than 4/10. If an allergy to fentanyl is documented, the patient will be excluded from the study. Once a mechanically ventilated patient with sepsis is selected for enrollment, the patient will be randomized (via a computer-generated randomization program) to one of two sedation arms: 1) propofol, or 2) dexmedetomidine. Per current UMC policy, propofol will be initiated at 5 mcg/kg/minute (0.3mg/kg/hour) and titrated every 5 minutes by 5mcg/kg/minute to RASS (Richmond Agitation and Sedation Scale) goal -1 to +1. The maximum dose of propofol will be 80 mcg/kg/minute. Dexmedetomidine will be initiated at 0.2 mcg/kg/hour and will be titrated every 5 minutes by 0.1mcg/kg/hour to a maximum dose of 1.4 mcg/kg/hour to a RASS goal of -1 to +1. Although dexmedetomidine has only been approved in the United States for short-term sedation of ICU patients (< 24 hrs) at a maximal dose of 0.7 μg/kg/hr (up to 1.0 μg/kg/h for procedural sedation), several studies demonstrate the safety and efficacy of dexmedetomidine infusions administered for greater than 24 hrs (up to 28 days) and at higher doses (up to 1.5 μg/kg/hr). Daily sedation stops will be performed in both study arms per MICU weaning policy. Patients will be allowed to return to a RASS of 0 to +1, and the physician will be alerted for assessment. If the physician determines sedation needs to be re-started, it will be at 50% of the dose prior to the sedation stop. This dose will then be titrated to a RASS goal of -1 to +1. Patients with inadequate sedation scores on their assigned drug will receive supplemental sedation with midazolam or lorazepam using IV boluses as needed based on nursing and physician assessment.

Inclusion Criterias

who require mechanical ventilation, and
provide informed consent either personally or by an authorized representative.
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.
with the diagnosis of sepsis (as specified below) within the previous 24 hours
Men and women 18-89 years old

Exclusion Criterias

Current triglyceride level > 400 mg/dl
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
...
Current triglyceride level > 400 mg/dl
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.

Locations

Lubbock, Texas, 79415
Lubbock, Texas, 79415

Tracking Information

NCT #
NCT02203019
Collaborators
Not Provided
Investigators
  • Principal Investigator: Kenneth Nugent, MD Texas Tech University Health Sciences Center
  • Kenneth Nugent, MD Texas Tech University Health Sciences Center