NCT05246644

IV Acetaminophen After Cardiac Surgery - PILOT

Pilot Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 900 (estimated)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Delirium

Interventions

Type	Name	Description
DRUG	acetaminophen	we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen

Timeline

• Start date: 2023-06-06
• Primary completion: 2024-09-30
• Completion: 2024-12-15
• First posted: 2022-02-18
• Last updated: 2024-02-28

Locations

2 sites across 1 country: Canada