Clinical and Economic Outcome of Simvastatin in Critically Ill Septic Patient
The Clinical Outcome and the Cost-effectiveness Analysis of Simvastatin Plus Standard Therapy Versus Standard Therapy Alone in Critically Ill Septic Patient"
調査の概要
詳細な説明
Prospective double blinded randomized controlled study Will be carried out at Ain-Shams university hospital Method: - After approval of the research ethics committee of Ain shams University and obtaining consent from each patient, 100 patients newly admitted to the intensive care unit (ICU) diagnosed to have sepsis/severe sepsis defined by American College of Chest Physicians (ACP) *will be randomized by the clinical pharmacist using a computer-generated randomization sequence with a block size of four into two groups.
Group I (Control group):-50 patients will be treated according to "Surviving Sepsis Campaign guidelines (SSCG) (Dellinger, et al. 2013) Group II (Intervention group):-50 patients will be treated according SSCG plus simvastatin.
Outcomes:- Primary outcome measures: 28 day ICU and hospital mortality.
Secondary Outcome Measures:
- Requirement and length of renal replacement therapy, vasoactive agent support or mechanical ventilation
- Total ICU length of stay.(LOS)
- Number of patients alive 3, 6, and 12 months
- Incremental cost effectiveness ratio
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Cairo、エジプト、11361
- Ain shams university hospital and cairo university hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:-
- Age >18 and less than 70
- Sepsis for less than 24 hours from ICU admission
Exclusion criteria:-
- Elderly (defined as older than 70).
- Pediatrics (defined as younger than 18).
- Pregnancy and nursing.
- Unable to receive enteral medications.
- History of hypersensitivity to the trial drug.
- Are receiving drugs known to interact with simvastatin.
- Acute liver failure and chronic liver disease (Child C).
- High risk of rhabdomyolysis (multiple traumas, crush injuries, extensive burns(>60%), baseline creatinine kinase (CK) ≥ten-times upper limit of normal.
- Patients with dyslipidemia or Prior statin user.
- Sever renal impairment (defined as need for replacement therapy )and uncontrolled hypothyroidism
- Have a history of known or suspected porphyria
- Are unlikely to survive more than 24 hours
研究計画
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：broad spectrum AB +fluids
Control group :50 patients will be treated according to SURVIVING SEPSIS CAMPAIGN BUNDLES
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アクティブコンパレータ：simvastatin
50 patients will be treated according SSCG plus simvastatin as single oral tablet 40 mg / day begin with inclusion in the study and continue until hospital discharge .If the patient is able to swallow; the tablet will be given orally.
Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube.
(White R, Bradnam V, 2013)
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single oral tablet 40 mg / day If the patient is able to swallow; the tablet will be given orally.
Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube
他の名前：
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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 |
時間枠 |
|---|---|
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28 day ICU and hospital mortality
時間枠：one year
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one year
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Number of patients alive 3, 6, and 12 months and incremental cost effectiveness ratio
時間枠：one year
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one year
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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ICU hazards
時間枠：one year
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one year
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協力者と研究者
捜査官
- 主任研究者：sara M amin, MSC、Ain Shams University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。