Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750616
Status:
RECRUITING
Last Update Posted:
2023-07-18
First Post:
2021-01-29
Brief Title:
NAD Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
Sponsor:
Kaiser Permanente
Organization:
Kaiser Permanente
Study Overview
Official Title:
NAD Augmentation in Cardiac Surgery Associated Myocardial Injury NACAM Trial
Status:
RECRUITING
Status Verified Date:
2023-07
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:
NACAM
Brief Summary:
A Randomized Double-blind placebo-controlled Trial to Evaluate the Efficacy of Oral Nam for the Prevention of Acute Kidney Injury in Patients Undergoing On-Pump Cardiac Surgery
Detailed Description:
This trial is a single-center randomized double-blind placebo-controlled Trial of Nam versus placebo in patients undergoing on-pump cardiac surgery After screening and enrollment patients will be stratified according to CKD status eGFR45 mlminm2 and surgical site and randomized in a 11 manner to receive either Nam 3 grams or placebo on the day of surgery and post-surgical days one and two
The overall trial duration is planned for 42 months consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled
The overall trial duration is planned for 42 months consisting of 39 months of active recruitment and treatment period and three months of follow-up from the last patient enrolled
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None