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very low recruitment
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone group | Experimental |
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| Non-Methadone group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone group | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants on Methadone That Get Extubated | from day of intubation to day 5 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal Kingah, MD,MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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Of the 2 participants enrolled, 1 withdrew before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Non-Methadone Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2024 |
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| Usual care | Drug | Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols |
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| 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 ) |
Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols |
| COMPLETED |
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| NOT COMPLETED |
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Includes all participants that were randomized. 0 participants were randomized to the non-methadone group arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Non-Methadone Group | Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Cause of Lung Injury | Count of Participants | Participants |
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| Weight | Mean | Standard Deviation | Kilograms |
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| Duration on ventilator at time of randomization | Mean | Standard Deviation | hours |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants on Methadone That Get Extubated | 0 participants were randomized to the non-methadone group arm. | Posted | Count of Participants | Participants | from day of intubation to day 5 |
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| Secondary | Number of Participants That Develop Prolonged Corrected QT Interval (QTC) After Administration of Methadone | 0 participants were randomized to the non-methadone group arm. | Posted | Count of Participants | Participants | from first day patient given Methadone to date patient discharged or transferred from hospital (up to about 27 days after admission) |
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| Secondary | ICU Length of Stay | 0 participants were randomized to the non-methadone group arm. | Posted | Mean | Standard Deviation | days | From time of admission to ICU to time of discharge from ICU (about 27 days after admission) |
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| Secondary | ICU Mortality | 0 participants were randomized to the non-methadone group arm. | Posted | Count of Participants | Participants | end of ICU stay (up to about 27 days after admission) |
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| Secondary | Hospital Length of Stay | 0 participants were randomized to the non-methadone group arm. | Posted | Mean | Standard Deviation | days | from time to admission to time of discharge from hospital (about 27 days after admission) |
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| Secondary | Hospital Mortality. | 0 participants were randomized to the non-methadone group arm. | Posted | Count of Participants | Participants | end of hospital stay (up to about 27 days after admission ) |
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27 days
0 participants are at risk for serious adverse events, all cause mortality and other (not including serious) adverse events because 0 participants were enrolled in the Non-Methadone Group arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | Non-Methadone Group | Usual care: Participants will receive usual care with IV Fentanyl or hydromorphone per hospital protocols | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pascal Kingah, MD,MPH | The University of Texas Health Science Center at Houston | 713-500-6828 | Pascal.L.Kingah@uth.tmc.edu |
| Jul 15, 2025 |
| Prot_SAP_000.pdf |
| >=65 years |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Non-pulmonary Sepsis |
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| Chronic Obstructive Pulmonary Disease (COPD) Exacerbation |
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| Other Causes |
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