Donors After Cardiac Death: Validating Identification Criteria
調査の概要
詳細な説明
Our study is a simple, observational study. We intend to record the events that occur between the time withdrawal of life sustaining treatment occurs, and the time of death. Our preliminary data, reported in the journals Critical Care Medicine and Pediatric Critical Care Medicine, show that the median time to death is about 25 minutes, and few survive over an hour. We would directly observe no patient for longer than one hour.
This is a straightforward study to characterize the Receiver Operator Characteristic (ROC) curves and Relative Risk of a variety of clinical data elements for predicting early death following discontinuation of life sustaining treatments. This is a multi-center study currently being conducted at: University of Cincinnati Hospital, Case-Western Reserve University Hospital and the University of Pittsburgh Medical Center with the University of Pittsburgh acting as the Coordinating Center. (a) This is a prospective cohort study of patients electively withdrawn from life sustaining treatment. The investigators and the study have no impact on the decision or timing of withdrawal of support. The study will merely record what and what time support is withdrawn, the medications that are provided for patient comfort, and the time of death. Within this group, we will determine whether patients who "meet" the UNOS criteria (UNOS cohort) have a short time to death, enabling us to validate the current, unvalidated UNOS criteria. In addition, we will analyze data from all patients, perform logistic regression to determine other candidate criteria for determining short time to death. (b) Data extractors will collect the data from all identified patients using chart review following procedures approved by their institutional review board. Data forms will be de-identified at each institution prior to transmission to our central database to ensure patient confidentiality.
The results from the project we are proposing will enable more accurate identification of appropriate candidates for NHBOD. We plan to do this by examining pre-mortem data of patients that have died after withdrawal of LST to see if any factors or combination of factors are predictive of death in less than 30 minutes and 60 minutes after LST is removed.
Our research questions are:
- Do the UNOS criteria predict early death following discontinuation of LST? 2. In addition we will collect data to enable us to address the secondary questions:
- a. What are the best predictors of early death following discontinuation of LST?, and 2.b. How accurate are they?
We intend to test the following two hypotheses:
H1: The UNOS criteria are predictive of death in less than 30 minutes; H2: The UNOS criteria are predictive of death within 60 minutes.
The researchers selected the following outcomes for the study. Outcome 1: death within 30 minutes of removal of life sustaining treatment. Outcome 2: death within 60 minutes of removal of life sustaining treatment. Outcome 3: number of potential organ donors following cardiac death
研究の種類
入学
連絡先と場所
研究場所
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Ohio
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Cincinnati、Ohio、アメリカ、45267
- University of Cincinnati Medical Center
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Cleveland、Ohio、アメリカ、44106
- Case Western Reserve University
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
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Pittsburgh、Pennsylvania、アメリカ、15213
- Childrens Hospital of Pittsburgh
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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:
- all patients who have life sustaining treatments withdrawn
Exclusion Criteria:
- confirmed brain death
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
- 時間の展望:見込みのある
協力者と研究者
スポンサー
捜査官
- スタディチェア:Michael A DeVita, MD、University of Pittsburgh/University of Pittsburgh Medical Center
- 主任研究者:Christine Zowistowski, MD、University of Tennesse, Memphis
- 主任研究者:Maria Brooks, PhD、University of Pittsburgh
研究記録日
主要日程の研究
研究開始
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
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。
withdrawal of life sustaining treatmentsの臨床試験
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Hürriyet YılmazMedipol University完了
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University of LincolnNottinghamshire Healthcare NHS Trust募集
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Bogomolets National Medical University完了
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Pediatric Clinical Research PlatformUniversity Hospital, Geneva; Swiss Federal Institute of Technology; Hôpital du Valais募集