Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624945
Status:
RECRUITING
Last Update Posted:
2023-07-27
First Post:
2020-11-05
Brief Title:
DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE The DISSIPATE Study
Sponsor:
National University Hospital Singapore
Organization:
National University Hospital Singapore
Study Overview
Official Title:
DetectIon of Severe Sepsis In PATients With Neurological haemorrhagE The DISSIPATE Study
Status:
RECRUITING
Status Verified Date:
2023-06
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:
DISSIPATE
Brief Summary:
The research study is to explore novel early predictors and validation of laboratory parameters in the management of sepsis in critically ill patients especially with brain injuries and systemic inflammatory response syndrome SIRS
Detailed Description:
This is a prospective observational study 150 subjects with the admission diagnosis of neurological haemorrhage eg subarachnoid haemorrhage intracerebral haemorrhage etc admitted to SICU of National University Hospital Singapore who are expected to stay for more than 48 hours will be recruited and enrolled No adverse events are expected as a result of this study as patients do not deviate from the current standard of care Frequency of blood sampling will be stipulated at day 12345 to draw clinical relevance An additional 05 tablespoonful 77ml of blood will be taken daily from each subject as well as residual blood from routine laboratory test blood samples In total an additional volume of 25 tablespoonful 385ml of blood will be collected from each subject over a period of 5 days Residual blood refers to any leftover blood samples collected for routine laboratory tests which will be shared and used to carry out additional blood tests All ICU patients will have arterial lines inserted as part of routine care so there will not be pain from the blood sampling In the current study measurements will be made on the routine laboratory haematology coagulation and immunoassay analyzers Research blood parameters that are not usually reported as indicated in the background section will be used for the correlation and association analysis to sepsis In addition the study team will also be collecting clinical and demographic data of recruited subjects from medical records for purposes of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None