Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06613178
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-03-01
Brief Title:
Intravenous Acetaminophen After Cardiac Surgery - Definitive Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intravenous Acetaminophen After Cardiac Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IVACS
Brief Summary:
Double blind double dummy trial of the use of IV acetaminophen versus oral acetaminophen for the prevention of delirium after cardiac surgery The underlying hypothesis is that better pain control and less use of narcotics will lead to a lower incidence of delirium from day 1 to 7 following cardiac surgery Other important secondary outcomes are the total use of narcotics ICU and hospital stay improved cognitive function at 6 months and 1 year post surgery NSAID use at each centre and associated NSAID complications
Detailed Description:
Patients gt or equal to 18 years of going for elective cardiac surgery will be randomized to receive IV either IV acetaminophen and an oral placebo acetaminophen or an IV placebo acetaminophen saline and oral acetaminophen every 6 hours for 48 hours after cardiac surgery the study will be performed at 8 large Canadian cardiac surgery centres All other therapy will be as per standard procedures pragmatic at the institutions including including use of their standard opioid protocol The primary end-point is the development of delirium as assessed by Confusion Assessment Method in the Intensive Care unit CAMICU and the CAM on the regular floor unit for up to 7 days after surgery or discharge if it is sooner Other measures are change from pre-operative cognitive function as assessed by the Montreal Cognitive Assessment score MoCA at 6 months and 1 year numeric pain score total opioid use hospital and ICU length of stay Use of opioids and pain score at 1 year also will be assessed Patients will be stratified by site and sex
We also will assess use of NSAID specifically ketorolac and any NSAID associated events
We also will assess use of NSAID specifically ketorolac and any NSAID associated events
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