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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06110546

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Effect of Methadone on the Duration on Mechanical Ventilation	Drug: Methadone group Drug: Usual care	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Nov 15, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Nov 15, 2025

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of participants on methadone that get extubated [from day of intubation to day 5]

Secondary Outcome Measures

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 )]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pascal Kingah, Associate Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT06110546

Other Study ID Numbers:

HSC-MS-22-0689

First Posted:

Oct 31, 2023

Last Update Posted:

Oct 31, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Pascal Kingah, Associate Professor, The University of Texas Health Science Center, Houston

opioids

mechanical ventilation

Additional relevant MeSH terms:

Methadone

Study Results

No Results Posted as of Oct 31, 2023