Clinical trial NCT06110546: Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids
Official title: Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids, a Randomized Trial (IMPACTOR Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Effect of Methadone on the Duration on Mechanical Ventilation
Keywords: opioids
mechanical ventilation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants on methadone that get extubated
timeFrame: from day of intubation to day 5
Secondary outcomes:
measure: Number of participants that develop prolonged corrected QT interval (QTC) after administration of methadone
timeFrame: from first day patient given Methadone to date patient discharged or transferred from hospital( upto about 7 days after admission )
measure: ICU length of stay
timeFrame: at time of discharge from ICU( upto about 3 days after admission )
measure: ICU mortality
timeFrame: end of ICU stay ( upto about 3 days after admission )
measure: hospital length
timeFrame: at time of discharge from hospital ( upto about 7 days after admission )
measure: hospital mortality.
timeFrame: end of hospital stay ( upto about 7 days after admission )
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Pascal Kingah, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References: