IV Acetaminophen After Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of Intravenous or Oral Acetaminophen After Cardiac Surgery

Conditions
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Delirium

Intervention / Treatment
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* Drug: acetaminophen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized double blind double dummy
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous Acetaminophen<br>subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses | Drug: acetaminophen<br>* we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen<br>* Other names: placebo;|
| Active Comparator: Oral acetaminophen<br>subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses | Drug: acetaminophen<br>* we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid usage | tabulation of all opioids normalized to morphine | up to 7 days post-operatively | 
| Numeric pain rating scale | visual pain score from 1 to 10 | up to 48 hours | 
| cognitive function | change in cognitive function score by 2 based on the Montreal cognitive assessment | 7 days post-operative, 6 months and 1 year | 
| 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 | 
| 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 |