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

Impact of Methadone on Prolonged Mechanical Ventilation in Patients on Continuous Treatment With Opioids, a Randomized Trial (IMPACTOR Study)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Effect of Methadone on the Duration on Mechanical Ventilation
• Intervention / Treatment: Drug: Methadone group; Drug: Usual care

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Pascal Kingah, MD,MPH; Phone Number: (713) 500-6828; Email: Pascal.L.Kingah@uth.tmc.edu
• Study Contact Backup: Name: Elizabeth Vidales; Phone Number: (713) 486-8000; Email: Elizabeth.Vidales@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Elizabeth Vidales; Phone Number: (713) 486-8000; Email: Elizabeth.Vidales@uth.tmc.edu
      • Contact: Pascal Kingah, MD, MPH; Phone Number: 713-500-6828; Email: Pascal.L.Kingah@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Methadone group	Drug: Methadone group; Participants will be started on Methadone 5mg, 10mg or 15mg every 8 hours depending on Fentanyl drip rate (0-100mcg/hr, 100-200mcg/hr or >200mcg/hr) or hydromorphone drip rate (0-1.5mg/hr, 1.5-3mg/hr, or >3mg/hr).
Active Comparator: Non-Methadone group	Drug: Usual care; Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants on methadone that get extubated	from day of intubation to day 5

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants that develop prolonged corrected QT interval (QTC) after administration of methadone	from first day patient given Methadone to date patient discharged or transferred from hospital( upto about 7 days after admission )
ICU length of stay	at time of discharge from ICU( upto about 3 days after admission )
ICU mortality	end of ICU stay ( upto about 3 days after admission )
hospital length	at time of discharge from hospital ( upto about 7 days after admission )
hospital mortality.	end of hospital stay ( upto about 7 days after admission )

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Pascal Kingah, MD,MPH, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 15, 2025

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: mechanical ventilation; opioids
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Respiratory System Agents; Antitussive Agents; Methadone
• Other Study ID Numbers: HSC-MS-22-0689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No