Status:
TERMINATED
Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Effect of Methadone on the Duration on Mechanical Ventilation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the effect of methadone on the duration on mechanical ventilation in critically ill patients receiving more than 72 hours of mechanical ventilation (MV) by co...
Eligibility Criteria
Inclusion
- Patients on Intermittent mandatory ventilation (IMV) for more than 72 hours
- Patients infused Fentanyl or Hydromorphone for more than 72 hours
- Patients with evidence of reversal of process that caused respiratory failure, adequate oxygenation (PaO2/fraction of inspired oxygen (FiO2)\>200; Positive end expiratory pressure (PEEP)≤8 and Ph≥7.2
- Patients hemodynamically stable
- Patients with a failed single or multiple attempts at spontaneous breathing trials
Exclusion
- Patients with history of opioid drug abuse
- Patients receiving schedule II narcotics on a chronic basis for longer than 6 months prior to ICU admission or on other analgesic infusions other than Fentanyl or Hydromorphone
- Patients with cervical spinal cord injury or neuromuscular disease
- Patients with end stage liver disease at ICU admission (ie, International normalized ratio ≥2and not taking warfarin and/or a total serum bilirubin ≥1.5 times above normal limits
- Patients with prolonged QTc interval ≥500
- Patients with prior history of cardiac conduction defects or sudden death
- Patients with QTc increase of ≥60 milliseconds above the value of prior EKGs measured during current ICU admission
- Patients with more than 5 days on IV analgesia
- Patients intubated for more than 3 days
- Patients without feeding tubes
- Patients not receiving enteral feeding
Key Trial Info
Start Date :
February 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2024
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT06110546
Start Date
February 18 2024
End Date
February 22 2024
Last Update
August 1 2025
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030