Effect of Methadone on the Duration on Mechanical Ventilation
Conditions
Keywords
opioids, mechanical ventilation
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
Interventions
DRUGMethadone 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).
DRUGUsual care
Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants on Methadone That Get Extubated | from day of intubation to day 5 |
Secondary
| 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 (up to about 27 days after admission) |
| ICU Length of Stay | From time of admission to ICU to time of discharge from ICU (about 27 days after admission) |
| ICU Mortality | end of ICU stay (up to about 27 days after admission) |
| Hospital Length of Stay | from time to admission to time of discharge from hospital (about 27 days after admission) |
| Hospital Mortality. | end of hospital stay (up to about 27 days after admission ) |
Countries
United States
Participant flow
Pre-assignment details
Of the 2 participants enrolled, 1 withdrew before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Methadone Group 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). | 1 |
| Non-Methadone Group Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Methadone Group | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Cause of Lung Injury Aspiration | 0 Participants | 0 Participants |
| Cause of Lung Injury Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 0 Participants | 0 Participants |
| Cause of Lung Injury Non-pulmonary Sepsis | 0 Participants | 0 Participants |
| Cause of Lung Injury Other Causes | 0 Participants | 0 Participants |
| Cause of Lung Injury Pneumonia | 1 Participants | 1 Participants |
| Duration on ventilator at time of randomization | 78 hours | 78 hours |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
| Weight | 129.9 Kilograms | 129.9 Kilograms |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Number of Participants on Methadone That Get Extubated
Time frame: from day of intubation to day 5
Population: 0 participants were randomized to the non-methadone group arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methadone Group | Number of Participants on Methadone That Get Extubated | 1 Participants |
Secondary
Hospital Length of Stay
Time frame: from time to admission to time of discharge from hospital (about 27 days after admission)
Population: 0 participants were randomized to the non-methadone group arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Methadone Group | Hospital Length of Stay | 27 days |
Secondary
Hospital Mortality.
Time frame: end of hospital stay (up to about 27 days after admission )
Population: 0 participants were randomized to the non-methadone group arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methadone Group | Hospital Mortality. | 0 Participants |
Secondary
ICU Length of Stay
Time frame: From time of admission to ICU to time of discharge from ICU (about 27 days after admission)
Population: 0 participants were randomized to the non-methadone group arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Methadone Group | ICU Length of Stay | 27 days |
Secondary
ICU Mortality
Time frame: end of ICU stay (up to about 27 days after admission)
Population: 0 participants were randomized to the non-methadone group arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methadone Group | ICU Mortality | 0 Participants |
Secondary
Number of Participants That Develop Prolonged Corrected QT Interval (QTC) After Administration of Methadone
Time frame: from first day patient given Methadone to date patient discharged or transferred from hospital (up to about 27 days after admission)
Population: 0 participants were randomized to the non-methadone group arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Methadone Group | Number of Participants That Develop Prolonged Corrected QT Interval (QTC) After Administration of Methadone | 0 Participants |