Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01059929
Other study ID # 16865B
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date September 2009
Est. completion date September 2015

Study information

Verified date July 2018
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized controlled trial to compare propofol to dexmedetomidine for prolonged sedation (> 24 hours) in critically ill patients who require mechanical ventilation.


Description:

Mechanically ventilated critically ill patients are routinely given sedative and analgesic medications to relieve pain and anxiety associated with intubation, mechanical ventilation, and critical care in general. While integral in minimizing discomfort, these medications may increase mechanical ventilation time, the duration of intensive care unit (ICU) stay, ICU complications (e.g. delirium, ventilator associated pneumonia, venous thromboembolism), the morbidity associated with critical illness, and patient mortality. This study compares two sedative medications that have been used in patients who require a mechanical ventilator. Enrolled patients will be randomly assigned to receive propofol or dexmedetomidine for sedation while they require ventilatory support. All patients will also receive the pain medication fentanyl as needed.


Recruitment information / eligibility

Status Terminated
Enrollment 41
Est. completion date September 2015
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- >18 years old

- mechanically ventilated through endotracheal tube

- anticipated need for ventilation > 48 hours

- requiring sedative/analgesic medication

Exclusion Criteria:

- on mechanical ventilator > 96 hours

- primary neurologic disease

- post cardiac arrest

- do not speak English (assessment only English language validated)

- pregnancy or lactation

- active myocardial ischemia

- second or third degree heart block

- pancreatitis

- elevated serum triglycerides (> 400 mg/dL)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
continuous IV infusion 0.2 - 1.5 ucg/kg/hour titrated to target RASS
Propofol
continuous IV infusion (5 - 50 ucg/kg/min) titrated to target RASS
Fentanyl
25 - 200 mcg IV every hour (as multiple IV pushes) as needed titrated to Non-Verbal Pain Scale
Midazolam
0.01 - 0.1 mg/kg IV push every 10 minutes as needed for agitation (RASS>+2)
Behavioral:
Physical and Occupational Therapy
Daily therapy sessions targeting range of motion, strength, and mobility

Locations

Country Name City State
United States The University of Chicago Medical Center Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago Hospira, now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Days With Delirium delirium assessment using CAM-ICU daily up to 28 days
Secondary Drug Efficacy According to Richmond Agitation Sedation Scale (RASS) Score Richmond Agitation Sedation Scale (RASS). This is a validated scale that measures level of sedation. The scale ranges from -5 to +4. -5 refers to a state where one is unarousable, +4 refers to a state where one is combative. The median and inter-quartile range over all daily assessments will be provided. Daily up to day 28
Secondary Number of Patients Completing Mobility Milestones Milestones: sitting upright independently, standing independently, transfer to chair, marching in place, ambulating independently Daily through day 28
Secondary Days on Ventilator 60 days from enrollment
Secondary Days in ICU 60 days from enollment
Secondary Mortality 28 days from enrollment
Secondary Number of Participants With ICU Complications daily through day 28
Secondary Number of Patients Requiring Fentanyl during infusion of study medication up to day 28
Secondary Number of Patients Requiring Midazolam during infusion of study medication through day 28
Secondary Days in Hospital 60 days from enrollment
Secondary Number of Patients Completing Activities of Daily Living activities of daily living: eating, bathing, dressing, grooming, toileting daily through day 28
Secondary Number of Adverse Medication Effects duration of infusion of study medication up to 28 days
See also
  Status Clinical Trial Phase
Completed NCT04551508 - Delirium Screening 3 Methods Study
Recruiting NCT06037928 - Plasma Sodium and Sodium Administration in the ICU
Completed NCT03671447 - Enhanced Recovery After Intensive Care (ERIC) N/A
Recruiting NCT03941002 - Continuous Evaluation of Diaphragm Function N/A
Recruiting NCT04674657 - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed NCT04239209 - Effect of Intensivist Communication on Surrogate Prognosis Interpretation N/A
Completed NCT05531305 - Longitudinal Changes in Muscle Mass After Intensive Care N/A
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Completed NCT02916004 - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients. N/A
Recruiting NCT05883137 - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed NCT04479254 - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study) N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Not yet recruiting NCT04538469 - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Recruiting NCT02989051 - Fluid Restriction Keeps Children Dry Phase 2/Phase 3
Recruiting NCT02922998 - CD64 and Antibiotics in Human Sepsis N/A
Completed NCT03048487 - Protein Consumption in Critically Ill Patients
Completed NCT02899208 - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients? N/A
Recruiting NCT02163109 - Oxygen Consumption in Critical Illness