Evaluation of Resuscitation Markers in Trauma Patients
Severe trauma patients have an elevated risk of multiple organ failure and death. In order to increase survival possibilities the initial treatment must be focused into resuscitation from shock. Traditionally the most common resuscitation markers used are vital signs and urine output. Unfortunately, many patients might present normal vital signs, but still undergo a compensated shock with persistent acidosis, hence being able to develop multiple organ failure and death. Consequently, it is important to define better resuscitation markers for these patients.
This investigation project consists in an observational prospective study, performed by a multidisciplinary team, in which different resuscitation markers are evaluated in severe trauma patients. There will be a specific timing (1st, 8th and 24th hours from arrival) evaluation of different markers: hemodynamic (vital signs, urine output, etc); analytical (lactate, base excess, natriuretic atrial peptide); tissue perfusion markers (NIRS); microcirculation markers (videomicroscopy) and coagulopathy markers (thromboelastometry). There will be a registry of total volume administration; blood cell transfusions and vasoactive drug requirements. Each marker will be evaluated in relation to mortality; multiple organ failure; massive transfusion protocol activation; blood cell transfusion requirement; surgical control of bleeding requirement and emergent arteriographic embolization. The objective of this study is to demonstrate which of these markers is better to predict hemodynamic evolution of severe trauma patients and might become a guide for resuscitation in the future.
調査の概要
状態
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Barcelona
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Sabadell、Barcelona、スペイン、08208
- Corporacion Sanitaria Parc Tauli
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Pre-hospital Priority 0 protocol activation:
- Glasgow coma scale < 14
- Systolic blood pressure < 90 mmHg
- Respiratory rate < 10 or > 29 breaths per minute
- Absent peripheral pulses
- Pre-hospital Priority 1 protocol activation:
- All penetratin injuries to head, neck, torso and extremities proximal to elbow and knee
- Flail chest
- Two or more proximal long-bone fractures
- Crushed, degloved or mangled extremity
- Amputation proximal to wrist and ankle
- Pelvic fracture
- Open or depressed skull fracture
- Paralysis
Exclusion Criteria:
- Hospitalization < 24 hours ( transport of the patient to an other trauma center)
- Patients transported from an other hospital (first hours of medical support done elsewhere)
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
コホートと介入
グループ/コホート |
介入・治療 |
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Severe trauma patients
No interventions are done. It's a prospective and descriptive observational study where different markers are analyzed:
All these markers are analyzed at the 1rst, 8th and 24th hour from hospital admission. |
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
Analyzed at the 1rst, 8th and 24th hour from hospital admission
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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 |
---|---|---|
Mortality
時間枠:Through study completion, an average of 1-2 years
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Death of the patient
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Through study completion, an average of 1-2 years
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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 |
---|---|---|
Multiple organ dysfunction (Multiple Organ Dysfunction Score)
時間枠:Through study completion, an average of 1-2 years
|
Marshall's score (MODS Score) consist on the analysis of 6 systems through different descriptors, those descriptors include: a) the respiratory system (pO2/FIO2 ratio); b) the renal system (serum creatinine concentration); c) the hepatic system (serum bilirrubine concentration); d) the hematologic system (platelet count); and e) the central nervous system (Glasgow Coma Scale); and f) the cardiovascular system (pressure adjusted heart rate).
The cardiovascular system descriptor is calculated as the product of the heart rate and the ratio of central venous pressure to mean arterial pressure.
All these descriptors will be measured during the first 24h from hospital admission.
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Through study completion, an average of 1-2 years
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Blood cell transfusion
時間枠:Through study completion, an average of 1-2 years
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Need for blood cell transfusion for patients
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Through study completion, an average of 1-2 years
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Activation of the Massive blood transfusion protocol
時間枠:At hospital admission
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Need for massive transfusion protocol activation on patients with suspicion of active bleeding
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At hospital admission
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Surgical intervention for bleeding control
時間枠:Through study completion, an average of 1-2 years
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Need for surgical control on patients with active bleeding
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Through study completion, an average of 1-2 years
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Arteriographic embolization for bleeding control
時間枠:Through study completion, an average of 1-2 years
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Need for arteriographic embolization on patients with active bleeding
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Through study completion, an average of 1-2 years
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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 |
---|---|---|
Hospital stay
時間枠:Through study completion, an average of 1-2 years
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Number of days that the patient remains in hospital
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Through study completion, an average of 1-2 years
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Intensive care unit stay
時間枠:Through study completion, an average of 1-2 years
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Number of days that the patient remains in the intensive care unit
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Through study completion, an average of 1-2 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Andrea Campos-Serra, MD、Corporacion Sanitaria Parc Tauli
- スタディディレクター:Salvador Navarro-Soto, MD, PhD、Corporacion Sanitaria Parc Tauli
- スタディディレクター:Sandra Montmany-Vioque, MD, PhD、Corporacion Sanitaria Parc Tauli
出版物と役立つリンク
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 (実際)
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
本研究に関する用語
その他の研究ID番号
- CSPT-CG-PPT1
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。
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