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Opioid
Methadone for Mechanical Ventilation (IMPACTOR Trial)
Phase 4
Waitlist Available
Led By Pascal Kingah, MD,MPH
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients on Intermittent mandatory ventilation (IMV) for more than 72 hours
Patients infused Fentanyl or Hydromorphone for more than 72 hours
Must not have
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 prior history of cardiac conduction defects or sudden death
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial studies the effects of methadone on critically ill patients receiving long-term mechanical ventilation to determine safety and hospital length of stay.
Who is the study for?
This trial is for critically ill patients who've been on mechanical ventilation and opioid pain meds like Fentanyl or Hydromorphone for over 72 hours, are stable, and have had unsuccessful breathing trials. It's not for those with a history of opioid abuse, chronic narcotic use, certain heart or liver conditions, neuromuscular diseases, or without feeding tubes.
What is being tested?
The study tests if methadone can reduce the time critically ill patients need mechanical ventilation. Participants will either receive usual care or be given methadone. The main focus is to compare ventilator-free days from enrollment to discharge and assess safety and hospital stay length.
What are the potential side effects?
While specific side effects aren't listed here, methadone can generally cause drowsiness, light-headedness, respiratory issues when starting treatment or increasing dosage; it may also affect heart rhythm which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on a breathing machine for more than 3 days.
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I have been given Fentanyl or Hydromorphone for over 72 hours.
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I have tried and failed to breathe on my own without assistance.
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My breathing has improved, with stable oxygen levels and minimal support needed.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe liver disease and am not on warfarin with high INR and bilirubin levels.
Select...
I have a history of heart rhythm problems or sudden death in my family.
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I have a cervical spinal cord injury or neuromuscular disease.
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I have been on IV pain medication for more than 5 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Methadone groupExperimental Treatment1 Intervention
Group II: Non-Methadone groupActive Control1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
348,042 Total Patients Enrolled
Pascal Kingah, MD,MPHPrincipal InvestigatorThe University of Texas Health Science Center, Houston