Haemodynamic Effect of Intravenous Paracetamol during and after Cardiac Surgery

Phase 4

Completed

• Conditions: Cardiopulmonary bypass; Cardiac surgery; Anaesthesiology - Anaesthetics; Surgery - Surgical techniques; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12615001099516
• Lead Sponsor: Austin Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adult surgery patients (age >18 years)
2. Cardiac surgery requiring cardiopulmonary bypass

Exclusion Criteria

Paracetamol use 24 hours prior to surgery (in paracetamol only or in combination therapy)

Pregnancy

Chronic renal impairment (creatinine >250 umol/L)

Chronic liver disease (ALT >200IU/L)

Morbid obesity (BMI >35kg/m2)

Known allergic reaction to IV paracetamol

Consumption of caffeine (e.g. coffee or energy drinks), consumed within 10 hours of surgery

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is a composite outcome using pressure based haemodynamic variables, namely systolic blood pressure, diastolic blood pressure, mean arterial blood pressure. These will be recorded from a arterial line inserted as part of standard care that measure continuous systolic blood pressure, diastolic blood pressure, and mean arterial blood pressure.[The primary outcome will be measures at the following peri-operative timepoints using the measurements from the arterial line. <br><br>1. Baseline (BL) just after pulmonary artery catheter insertion<br>2. 5 minutes (T5)<br>3. 10 minutes (T10)<br>4. 15 minutes (T15)<br>5. 30 minutes (T30)<br>6. Pre-cardiopulmonary bypass<br>7. Rewarming<br>8. ICU arrival (ICU 1)<br>9. ICU 6 hours (ICU 6)<br>10. ICU 12 hours (ICU 12)]