IV Acetaminophen After Cardiac Surgery - PILOT

Delirium Clinical Trial

— IVACS-Pilot  

Official title:

Pilot Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05246644
• Other study ID #: MUHC-ACETAMINOPHEN
• Status: Recruiting
• Phase: Phase 3
• Start date: June 6, 2023
• Est. completion date: December 15, 2024

Study information

• Verified date: February 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: sheldon magder, MD
• Phone: 5149475918
• Email: sheldon.magder[@]mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: December 15, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• acetaminophen
we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (4)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre	Canadian Institutes of Health Research (CIHR), Montreal Heart Institute, University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of delirium post operatively	Incidence of delirium will be analyzed between patients treated with IV or oral acetaminophen, measured from 24 hours post-operation and daily until discharge. Delirium will be defined as an acute change in pre-operative baseline condition with additional features of inattention and either disorganized thinking and altered loss of consciousness, as defined by the Confusion Assessment Method (CAM) or CAMICU when in the intensive care unit	up to 7 days post operatively
Secondary	total opioid usage	tabulation of all opioids normalized to morphine	up to 7 days post-operatively
Secondary	Numeric pain rating scale	visual pain score from 1 to 10	up to 48 hours
Secondary	cognitive function	change in cognitive function score by 2 based on the Montreal cognitive assessment	7 days post-operative, 6 months and 1 year
Secondary	hospital length of stay	Days until discharge	length of stay is measured from the day of surgery until the day of discharge from hospital in days
Secondary	Intensive care length of stay	hours in ICU	ICU stay is measured from the hour of arrival in the ICU and until the patient leaves the ICU in hours