IV Acetaminophen After Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-06

Study Completion Date

2024-12-15

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.

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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.

Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized double blind double dummy

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

blinded medication with codes kept in the pharmacy

Study Groups

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Intravenous Acetaminophen

subjects will receive IV acetaminophen and a placebo oral acetaminophen starting immediately after surgery and for 8 doses

Group Type EXPERIMENTAL

acetaminophen

Intervention Type DRUG

we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen

Oral acetaminophen

subjects will receive a placebo for IV acetaminophen and active oral acetaminophen starting immediately after surgery and for 8 doses

Group Type ACTIVE_COMPARATOR

acetaminophen

Intervention Type DRUG

we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen

Interventions

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acetaminophen

we will use IV acetaminophen and an oral placebo or IV placebo and active oral acetaminophen

Intervention Type DRUG

Other Intervention Names

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placebo

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No