Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids (IMPACTOR)

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Effect of Methadone on the Duration on Mechanical Ventilation

Treatments: Drug: Methadone group; Drug: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT06110546

HSC-MS-22-0689

Details and patient eligibility

About

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 comparing the number of ventilator free days from enrollment to the time of discharge, to assess the safety of methadone administration in critically ill patients while in the hospital and to determine hospital length of stay from the time of enrollment to the time of discharge

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Methadone group

Experimental group

Treatment:

Drug: Methadone group

Non-Methadone group

Active Comparator group

Treatment:

Drug: Usual care