Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06322537
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-02-21
Brief Title:
Albumin Utilization in Adult Cardiac Surgical Patients Retrospective
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Albumin Utilization for Intravascular Volume Replacement in Adult Cardiac Surgical Patients A Multi-centre Retrospective Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
AlbACS-1R
Brief Summary:
All heart surgery patients universally require hydration which is given through a vein in the arm but practices for treating patients are not universal There are disagreements about whether crystalloids should be used alone or in combination with albumin This question has important implications because albumin is an expensive blood product in relatively limited supply and 20 of its use is by heart surgery patients The goal of this study is to learn more about how crystalloids and albumin are used during heart surgery as well as key patient outcomes
Detailed Description:
The goal of this proposed multicentre retrospective cohort study is to characterize perioperative usage patterns of crystalloids and albumin as well as key patient outcomes in cardiac surgical patients This study will also address numerous other knowledge gaps in the area of perioperative blood product management and fluid administration in cardiac surgery and define a collaborative group to support future research in this field
The primary objective is to obtain granular information on if when and how albumin is given perioperatively to cardiac surgical patients This includes the doses and settings in which albumin is used the types of crystalloid solutions balanced or unbalanced used and when albumin is used for example while on cardio-pulmonary bypass in the ICU or on the ward in perioperative cardiac surgical care across institutions This important information about the scope of albumin and crystalloid use across the country will inform the design of our future intervention and control arms in the planned definitive trial
The primary objective is to obtain granular information on if when and how albumin is given perioperatively to cardiac surgical patients This includes the doses and settings in which albumin is used the types of crystalloid solutions balanced or unbalanced used and when albumin is used for example while on cardio-pulmonary bypass in the ICU or on the ward in perioperative cardiac surgical care across institutions This important information about the scope of albumin and crystalloid use across the country will inform the design of our future intervention and control arms in the planned definitive trial
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