- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00177606
Donors After Cardiac Death: Validating Identification Criteria
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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 (a) This is a prospective cohort study of patients electively withdrawn from life sustaining treatment.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 The study will merely record what and what time support is withdrawn, the medications that are provided for patient comfort, and the time of death.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
Type d'étude
Inscription
Contacts et emplacements
Lieux d'étude
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Ohio
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Cincinnati, Ohio, États-Unis, 45267
- University of Cincinnati Medical Center
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Cleveland, Ohio, États-Unis, 44106
- Case Western Reserve University
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15213
- University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, États-Unis, 15213
- Childrens Hospital of Pittsburgh
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- all patients who have life sustaining treatments withdrawn
Exclusion Criteria:
- confirmed brain death
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Perspectives temporelles: Éventuel
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Michael A DeVita, MD, University of Pittsburgh/University of Pittsburgh Medical Center
- Chercheur principal: Christine Zowistowski, MD, University of Tennesse, Memphis
- Chercheur principal: Maria Brooks, PhD, University of Pittsburgh
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0409061
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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