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recruitment issues
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This study will be a multicentre randomized, open-label, phase IIIb study. This study will evaluate two different techniques of sedation: an analgesia based regimen with remifentanil versus a conventional sedation based regimen using propofol in subjects that require mechanical ventilation for at least 2 days in the ICU. The conventional sedation based regimen will consist of propofol combined with an opioid according to routine clinical practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen will consist of remifentanil, with propofol added on if required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifentanil | Experimental | remifentanil |
|
| Propofol | Active Comparator | Propofol infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifentanil | Drug | analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Time on Mechanical Ventilation (Intent-to-Treat Population) | Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway). | Up to 38 days (912 hours) |
| Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population) | Time from start of mechanical ventilation until actual extubation. | Up to 38 days (912 hours) |
| Duration of Time on Mechanical Ventilation (Per-Protocol Population) | Time from start of mechanical ventilation until actual extubation | Up to 38 days (912 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator's Decision) | Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured. | Up to 38 days (912 hours) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting to require major surgery within the next three days
Subject who, in the judgement of the investigator, has a life expectancy of 2 days or refrained or refuses full life support, which would limit the care provided
Concurrent medications:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Catanzaro | Calabria | 88100 | Italy | ||
| GSK Investigational Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Remifentanil | Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate. |
| FG001 | Propofol | The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Remifentanil | Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Duration of Time on Mechanical Ventilation (Intent-to-Treat Population) | Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway). | Intent-to-Treat (ITT) Population: all randomised participants who had taken at least one dose of study medication | Posted | Mean | Standard Error | Hours (hr) | Up to 38 days (912 hours) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Remifentanil | Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077208 | Remifentanil |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
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| Propofol | Drug | conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical |
|
| Duration of Extubation |
Duration of extubation was measured. |
| up to 38 days (912 hours) |
| Duration of Weaning | Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured. | up to 38 days (912 hours) |
| Duration of Remifentanil Infusion (ITT Population) | Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | Up to 10 days (240 hours) |
| Duration of Propofol Infusion (ITT Population) | Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | up to 10 days (240 hours) |
| Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population) | Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | up to 10 days (240 hours) |
| Dose of Remifentanil Administered - Continuous Infusion | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | Up to 10 days |
| Doses of Sufentanil and Fentanil Administered - Continuous Infusion | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | up to 10 days |
| Dose of Propofol Administered - Continuous Infusion | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | Up to 10 days |
| Dose of Morphine Administered - Continuous Infusion | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | up to 10 days |
| Total Dose of Propofol Administered - Bolus | Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | Up to 10 days |
| Total Dose of Fentanil Administered - Bolus | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | Up to 10 days |
| Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale | Data from participants in the study for which the Sedation-Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain. | Up to 38 Days |
| Sedation-Agitation From Screening Through the End of Study | "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. | Up to 38 days |
| Sedation-Agitation for Day 7 | "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. | Day 7 |
| Sedation-Agitation From Day 8 to Day 10 | "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. | Days 8, 9, and 10 |
| Number of Participants Analyzed for BIS (Bispectral Index Scale) | Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia. | Up to 38 days |
| Bispectral Index (BIS) | The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia. | Screening through End of Study, up to 38 days |
| Bispectral Index (BIS) for Day 5 | The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia. | Day 5 |
| Bispectral Index (BIS) for Extubation Period and Post-Extubation Period | The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia. | up to 38 days |
| Pain Intensity (PI) | "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain. | Up to 38 days |
| Pain Intensity From Day 8 to Day 10 | "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain. | Days 8, 9, and 10 |
| Naples |
| Campania |
| 80131 |
| Italy |
| GSK Investigational Site | Ferrara | Emilia-Romagna | 44100 | Italy |
| GSK Investigational Site | Udine | Friuli Venezia Giulia | 33100 | Italy |
| GSK Investigational Site | Rome | Lazio | 00161 | Italy |
| GSK Investigational Site | Palermo | Sicily | 90127 | Italy |
| BG001 | Propofol | The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Simplified acute physiology score (SAPS II) score | The SAPS II score consists of adding the points from 17 variables: age, 12 physiological variables, type of admission, and 3 chronic disease variables. These variables are added to give a SAPS II score with a range of 0 ("predicted mortality" 0%) to 163 ("predicted mortality" 100%). SAPS II data were collected from local laboratories for 24 hours following ICU admission. | Mean | Standard Deviation | Points on a scale |
|
| OG001 |
| Propofol |
The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols. |
|
|
| Secondary | Duration of Time in Intensive Care Unit (ICU) and Potential Stay in ICU (the Time Expected for Extubation, i.e., the Time Between Intubation and Eligibility for Extubation, According to Investigator's Decision) | Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured. | ITT Population. Only participants with available ICU data were analyzed. | Posted | Mean | Standard Deviation | Hours | Up to 38 days (912 hours) |
|
|
|
| Primary | Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population) | Time from start of mechanical ventilation until actual extubation. | Modified-Intent-to-Treat (mITT) Population: all randomised participants who had taken at least one dose of study medication and who had efficacy measurements | Posted | Mean | Standard Error | Hours | Up to 38 days (912 hours) |
|
|
|
| Primary | Duration of Time on Mechanical Ventilation (Per-Protocol Population) | Time from start of mechanical ventilation until actual extubation | Per-Protocol (PP) Population: all participants from the MITT population without any major protocol violation | Posted | Mean | Standard Error | Hours | Up to 38 days (912 hours) |
|
|
|
| Secondary | Duration of Extubation | Duration of extubation was measured. | ITT Population. Only participants with available extubation data were analyzed. | Posted | Mean | Standard Deviation | hours | up to 38 days (912 hours) |
|
|
|
| Secondary | Duration of Weaning | Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured. | ITT Population. Only participants for which data are available were analyzed. | Posted | Mean | Standard Deviation | hours | up to 38 days (912 hours) |
|
|
|
| Secondary | Duration of Remifentanil Infusion (ITT Population) | Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants infused with Remifentanil were analyzed. | Posted | Mean | Standard Deviation | Hours | Up to 10 days (240 hours) |
|
|
|
| Secondary | Duration of Propofol Infusion (ITT Population) | Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants infused with Propofol were analyzed. | Posted | Mean | Standard Deviation | hours | up to 10 days (240 hours) |
|
|
|
| Secondary | Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population) | Data for this measure come from the infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants infused with Sufentanil, Fentanil, and Morphine were analyzed. | Posted | Mean | Standard Deviation | hours | up to 10 days (240 hours) |
|
|
|
| Secondary | Dose of Remifentanil Administered - Continuous Infusion | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants dosed with Remifentanil were analyzed. | Posted | Mean | Standard Deviation | ug/kg/h (micrograms per kilogram per hr) | Up to 10 days |
|
|
|
| Secondary | Doses of Sufentanil and Fentanil Administered - Continuous Infusion | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants dosed with Remifentanil were analyzed. | Posted | Mean | Standard Deviation | ug/kg/h | up to 10 days |
|
|
|
| Secondary | Dose of Propofol Administered - Continuous Infusion | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants dosed with Propofol were analyzed. | Posted | Mean | Standard Deviation | mg/kg/h (milligrams per kilogram per hr) | Up to 10 days |
|
|
|
| Secondary | Dose of Morphine Administered - Continuous Infusion | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants dosed with Morphine were analyzed. | Posted | Mean | Standard Deviation | mg/kg/h | up to 10 days |
|
|
|
| Secondary | Total Dose of Propofol Administered - Bolus | Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants dosed with Propofol were analyzed. | Posted | Mean | Standard Deviation | mg/kg | Up to 10 days |
|
|
|
| Secondary | Total Dose of Fentanil Administered - Bolus | Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system. | ITT Population. Only participants dosed with Fentanil were analyzed. | Posted | Mean | Standard Deviation | ug/kg | Up to 10 days |
|
|
|
| Secondary | Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale | Data from participants in the study for which the Sedation-Agitation Scale (SAS) and Pain Intensity (PI) were recorded were analyzed. "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain. | mITT Population | Posted | Number | participants | Up to 38 Days |
|
|
|
| Secondary | Sedation-Agitation From Screening Through the End of Study | "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. | mITT Population, according to the participants' status | Posted | Mean | Standard Deviation | Points on a scale | Up to 38 days |
|
|
|
| Secondary | Sedation-Agitation for Day 7 | "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. | mITT Population according to the participants' status | Posted | Mean | Standard Deviation | points on a scale | Day 7 |
|
|
|
| Secondary | Sedation-Agitation From Day 8 to Day 10 | "Sedation - Agitation" was assessed, using the "Riker Sedation-Agitation Scale" (SAS), by the following 7-point scale: 7, dangerous agitation; 6, very agitated; 5, agitated; 4, calm, cooperative; 3, sedated; 2, very sedated; 1, unarousable. | mITT Population according to the participants' status | Posted | Mean | Standard Deviation | points on a scale | Days 8, 9, and 10 |
|
|
|
| Secondary | Number of Participants Analyzed for BIS (Bispectral Index Scale) | Participants in the study for which BIS were evaluated. The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia. | mITT Population | Posted | Number | participants | Up to 38 days |
|
|
|
| Secondary | Bispectral Index (BIS) | The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia. | mITT Population. Due to the nonmandatory nature of BIS measure in the clinical practice, some participants did not have all the measures for all days in which they were in the study. | Posted | Mean | Standard Deviation | Points on a scale | Screening through End of Study, up to 38 days |
|
|
|
| Secondary | Bispectral Index (BIS) for Day 5 | The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia. | mITT Population. At Day 5, only one participant remained in the study; the others were already extubated. | Posted | Mean | Standard Deviation | points on a scale | Day 5 |
|
|
|
| Secondary | Bispectral Index (BIS) for Extubation Period and Post-Extubation Period | The BIS monitor provides a single dimensionless number, the BIS value, which ranges from 0 to 100. A BIS value of 0 equals electroencephalogram silence, near 100 is the expected value in a fully awake adult, and between 40 and 60 indicates a level for general anaesthesia. | mITT Population. The BIS value was recorded only for 2 participants, in the extubation and post-extubation periods. | Posted | Mean | Standard Deviation | points on a scale | up to 38 days |
|
|
|
| Secondary | Pain Intensity (PI) | "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain. | ITT Population, according to the participants' status. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day. | Posted | Mean | Standard Deviation | Points on a scale | Up to 38 days |
|
|
|
| Secondary | Pain Intensity From Day 8 to Day 10 | "Pain Intensity" was assessed by the following 6-point Pain Intensity Scale: 1, no pain; 2, mild pain; 3, moderate pain; 4, severe pain; 5 very severe pain; 6, worst possible pain. | mITT Population. Participants remained in the study until they could be extubated; thus, the number of participants analyzed may vary by day. | Posted | Mean | Standard Deviation | points on a scale | Days 8, 9, and 10 |
|
|
|
| 0 |
| 21 |
| 6 |
| EG001 | Propofol | The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols. | 0 | 18 | 3 |
| Ascites | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Oedema at surgical site | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Title | Measurements |
|---|---|
|
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Extubation period |
|
| Post-extubation period |
|
| Day 2 |
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Extubation period |
|
| Post-extubation period |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Day 3 |
|
| Day 4 |
|
| Day 5 |
|
| Day 6 |
|
| Day 7 |
|
| Day 8 |
|
| Day 9 |
|
| Day 10 |
|
| Extubation period |
|
| Post-extubation period |
|
| Title | Measurements |
|---|---|
|
| Day 3 (n = 5, 0) |
|
| Day 4 (n = 4, 0) |
|
| Day 2, n=18, 17 |
|
| Day 3, n=15, 14 |
|
| Day 4, n=10, 11 |
|
| Day 5, n=6, 3 |
|
| Day 6, n=2, 2 |
|
| Day 7, n=2, 1 |
|
| Extubation period, n=12, 12 |
|
| Post-extubation period, n=5, 6 |
|
| Title | Measurements |
|---|---|
|