Clinical trial NCT05246644: IV Acetaminophen After Cardiac Surgery - PILOT
Official title: Pilot Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Delirium
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Montreal Heart Institute
name: University of Manitoba
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-02-18
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized double blind double dummy
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* subjects \> 18 years of age undergoing elective aortocoronary bypass, single valve replacement or single valve and aortocoronary bypass surgery

Exclusion Criteria:

* • Refusal by surgeon for inclusion of the patient

  * Requested late extubation by anesthesia or surgeon
  * Intra-aortic balloon pump
  * Sensitivity to acetaminophen
  * Pre-operative cognitive dysfunction
  * Psychiatric history with active treatment
  * Parkinson's disease
  * Alzheimer's disease
  * Medication for cognitive decline
  * History of recent seizures
  * Recent history of alcohol misuse
  * Creatinine clearance less than 30 ml/min

Primary outcomes:
measure: Development of delirium post operatively
timeFrame: up to 7 days post operatively
Secondary outcomes:
measure: total opioid usage
timeFrame: up to 7 days post-operatively
measure: Numeric pain rating scale
timeFrame: up to 48 hours
measure: cognitive function
timeFrame: 7 days post-operative, 6 months and 1 year
measure: hospital length of stay
timeFrame: length of stay is measured from the day of surgery until the day of discharge from hospital in days
measure: Intensive care length of stay
timeFrame: ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
References: