Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)
2017年5月25日 更新者：GlaxoSmithKline
A Randomized, Open Label, Multicentre Study to Compare the Pharmaco-economic Implications of an Analgesia Based Regimen With Remifentanil and a Conventional Sedation Based Regimen Using Propofol in Medical and Post-surgical ICU Subjects Requiring Mechanical Ventilation for at Least 2 Days.
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.
調査の概要
研究の種類
介入
入学 (実際)
39
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Calabria
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Catanzaro、Calabria、イタリア、88100
- GSK Investigational Site
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Campania
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Napoli、Campania、イタリア、80131
- GSK Investigational Site
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Emilia-Romagna
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Ferrara、Emilia-Romagna、イタリア、44100
- GSK Investigational Site
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Friuli-Venezia-Giulia
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Udine、Friuli-Venezia-Giulia、イタリア、33100
- GSK Investigational Site
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Lazio
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Roma、Lazio、イタリア、00161
- GSK Investigational Site
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Sicilia
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Palermo、Sicilia、イタリア、90127
- GSK Investigational Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Medical and post-surgical patients admitted to ICU and requiring mechanical ventilation.
- Intubated subjects expected to require mechanical ventilation for longer than 48 hours after starting the study drug.
- Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic agent and an opioid.
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:
- Requires or is likely to require neuromuscular blocking agents by continuous infusion to facilitate mechanical ventilation
- Has or is likely to receive an epidural block during the treatment period
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：プロポフォール
プロポフォール点滴
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conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
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実験的：Remifentanil
remifentanil
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analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Duration of Time on Mechanical Ventilation (Intent-to-Treat Population)
時間枠：Up to 38 days (912 hours)
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Time from start of mechanical ventilation until actual extubation (the process of removing a tube from the airway).
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Up to 38 days (912 hours)
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Duration of Time on Mechanical Ventilation (Modified-Intent-to-Treat Population)
時間枠：Up to 38 days (912 hours)
|
Time from start of mechanical ventilation until actual extubation.
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Up to 38 days (912 hours)
|
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Duration of Time on Mechanical Ventilation (Per-Protocol Population)
時間枠：Up to 38 days (912 hours)
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Time from start of mechanical ventilation until actual extubation
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Up to 38 days (912 hours)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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)
時間枠：Up to 38 days (912 hours)
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Duration of Intensive Care Unit (ICU) stay and the duration of potential stay in the ICU were measured.
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Up to 38 days (912 hours)
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Duration of Extubation
時間枠：up to 38 days (912 hours)
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Duration of extubation was measured.
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up to 38 days (912 hours)
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Duration of Weaning
時間枠：up to 38 days (912 hours)
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Duration of weaning (the time from the intubation until the recovery of natural respiratory ability) was measured.
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up to 38 days (912 hours)
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Duration of Remifentanil Infusion (ITT Population)
時間枠：Up to 10 days (240 hours)
|
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.
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Up to 10 days (240 hours)
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Duration of Propofol Infusion (ITT Population)
時間枠：up to 10 days (240 hours)
|
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.
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up to 10 days (240 hours)
|
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Duration of Sufentanil, Fentanil, and Morphine Infusion (ITT Population)
時間枠：up to 10 days (240 hours)
|
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.
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up to 10 days (240 hours)
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Dose of Remifentanil Administered - Continuous Infusion
時間枠：Up to 10 days
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Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days
|
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Doses of Sufentanil and Fentanil Administered - Continuous Infusion
時間枠：up to 10 days
|
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
|
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Dose of Propofol Administered - Continuous Infusion
時間枠：Up to 10 days
|
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days
|
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Dose of Morphine Administered - Continuous Infusion
時間枠：up to 10 days
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Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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up to 10 days
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Total Dose of Propofol Administered - Bolus
時間枠：Up to 10 days
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Data from this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days
|
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Total Dose of Fentanil Administered - Bolus
時間枠：Up to 10 days
|
Data for this measure come from infusion pump display; the infusion pump infuses medication (analgesics and sedative agents) into the participant's circulatory system.
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Up to 10 days
|
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Number of Participants Analyzed for Sedation - Agitation Scale (SAS) and Pain Intensity (PI) Scale
時間枠：Up to 38 Days
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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.
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Up to 38 Days
|
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Sedation-Agitation From Screening Through the End of Study
時間枠：Up to 38 days
|
"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.
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Up to 38 days
|
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Sedation-Agitation for Day 7
時間枠：Day 7
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"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.
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Day 7
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Sedation-Agitation From Day 8 to Day 10
時間枠：Days 8, 9, and 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.
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Days 8, 9, and 10
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Number of Participants Analyzed for BIS (Bispectral Index Scale)
時間枠：Up to 38 days
|
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.
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Up to 38 days
|
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Bispectral Index (BIS)
時間枠：Screening through End of Study, up to 38 days
|
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.
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Screening through End of Study, up to 38 days
|
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Bispectral Index (BIS) for Day 5
時間枠：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.
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Day 5
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Bispectral Index (BIS) for Extubation Period and Post-Extubation Period
時間枠：up to 38 days
|
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)
時間枠：Up to 38 days
|
"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
|
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Pain Intensity From Day 8 to Day 10
時間枠：Days 8, 9, and 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.
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Days 8, 9, and 10
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2007年11月1日
一次修了 (実際)
2008年8月1日
研究の完了 (実際)
2008年9月1日
試験登録日
最初に提出
2007年2月15日
QC基準を満たした最初の提出物
2007年2月15日
最初の投稿 (見積もり)
2007年2月19日
学習記録の更新
投稿された最後の更新 (実際)
2017年5月30日
QC基準を満たした最後の更新が送信されました
2017年5月25日
最終確認日
2017年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。