Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177606
Status:
COMPLETED
Last Update Posted:
2017-05-31
First Post:
2005-09-13
Brief Title:
Donors After Cardiac Death Validating Identification Criteria
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Donors After Cardiac Death Validating Identification Criteria
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to validate a set of proposed clinical criteria that have been designed to identify patients who will die rapidly following the elective removal of life sustaining treatments
Detailed Description:
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University of Pittsburgh acting as the Coordinating Center a This is a prospective cohort study of patients electively withdrawn from life sustaining treatment The investigators and the study have no impact on the decision or timing of withdrawal of support The study will merely record what and what time support is withdrawn the medications that are provided for patient comfort and the time of death Within this group we will determine whether patients who meet the UNOS criteria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
1 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
2 a What are the best predictors of early death following discontinuation of LST and 2b 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
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
1 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
2 a What are the best predictors of early death following discontinuation of LST and 2b 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None