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IV Acetaminophen After Cardiac Surgery - PILOT — IVACS-Pilot  

Delirium Clinical Trial

Official title:
Pilot Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery

Clinical Trial Summary

Double blind double dummy of Intravenous Acetaminophen and oral acetaminophen placebo versus IV placebo versus oral acetaminophen in patients following cardiac surgery. The primary endpoint is development of Delirium during the post-operative stay.

Clinical Trial Description

The study is randomized, double-blinded, and multicentre. Enrollment includes patients 18 years or older who are going for aortocoronary bypass surgery, single valve, or bypass and single valve. The intervention is blinded IV acetaminophen and blinded oral active or placebo acetaminophen . The study will start with a pilot trial of 120 patients at 4 centers- 30 at each site, 15 per group. The pilot is a vanguard. If the pilot shows appropriate compliance with the protocol, reliable blinding and appropriate enrolment, the results will not be unblinded but rolled into the full study. Stratification will be by site and age < 60 or >= 60. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05246644
Study type Interventional
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact sheldon magder, MD
Phone 5149475918
Email sheldon.magder@mcgill.ca
Status Recruiting
Phase Phase 3
Start date June 6, 2023
Completion date December 15, 2024
View Details
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