search
Back to results

Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery (COPIA)

Primary Purpose

Coronary Heart Disease, Cardiovascular Diseases

Status
Unknown status
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Isoflurane, Sevoflurane or Desflurane
Propofol
Sponsored by
King's College Hospital NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Anaesthesia, Coronary Artery Bypass Surgery, Cardioprotection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients (male and female) aged 18 years and above
  • Written informed consent to participate
  • Patients undergoing Coronary Artery Bypass Graft (CABG) surgery on Cardiopulmonary bypass (CPB) with or without valve surgery
  • Additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 5 or higher

Exclusion Criteria:

  • Pregnant or lactating women
  • Allergy to propofol
  • Previous diagnosis or suspected malignant hyperthermia
  • Patients with a known sensitivity to any of the IMPs or other halogenated anaesthetics
  • Concomitant therapy with glibenclamide or nicorandil (medications that may interfere with preconditioning)
  • Inclusion in another clinical trial of an investigational medicinal product within the last 3 months.

Sites / Locations

  • St Thomas' Hospital
  • Kings College Hospital NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Volatile anaesthetics arm

Propofol anaesthetics arm

Arm Description

Patients randomised to receive volatile anaesthetics will receive either isoflurane, sevoflurane or desflurane during the surgical procedure.

Patients randomised to receive propofol will not receive any volatile anaesthetics during the surgical procedure.

Outcomes

Primary Outcome Measures

Recruitment rate
To identify whether it is feasible to recruit up to 50 patients across 2 tertiary cardiac surgery centres within approximately 10 months.
To identify barriers to recruitment.
This data will be completed on a screening log.

Secondary Outcome Measures

Feasibility of maintaining follow-up rates of over 95%
This data will be gathered in the trial database.
Assessment of effectiveness of patient identification and screening processes
To record the number of patients screened and potentially eligible for the trial at the two tertiary cardiac surgery centres within a period of 10 months. This data will be gathered on the screening log.
To investigate whether it is feasible to recruit at least 10% of all potentially eligible patients at the two tertiary cardiac surgery centres within a period of 10 months.
This data will be gathered on screening logs and in the randomisation system.
To investigate whether it is feasible to maintain routine data collection and follow up rates greater than 90% over the trial period.
This data will be gathered in the randomisation site and trial database.
To investigate whether it is feasible to achieve 95% data collection of Low Cardiac Output Syndrome for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 95% data collection of Myocardial injury, assessed by ischaemic serum markers: hsTnT, MyC, for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of MACCE (stroke, non-fatal myocardial infarction, death from any cause) for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of Cardiac related mortality at 30 days for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of Postoperative in hospital atrial fibrillation requiring treatment for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of Acute Kidney Injury (according to Kidney Disease: Improving Global Outcomes guidelines) for the full trial over the trial period.
AKI will be confirmed by a 1.5 - 1.9 increase of serum creatinine from baseline or an absolute value rise of creatine greater than 0.3mg/dl (27mmol/L) from baseline. This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of In-hospital postoperative delirium (assessed by the confusion assessment method) for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of Respiratory complications needing prolonged ventilation (>24 hours) for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of Length of stay in the critical care unit (CCU) for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of Length of hospital stay for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of WHO Disability Assessment Schedule (WHODAS) for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of Quality of Life Questionnaire (Euroqol, EQ-5D-5L) for the full trial over the trial period.
This data will be gathered in the trial database.
To investigate whether it is feasible to achieve 90% data collection of Days alive and at home for the full trial over the trial period.
This data will be gathered in the trial database.

Full Information

First Posted
June 7, 2019
Last Updated
February 23, 2021
Sponsor
King's College Hospital NHS Trust
Collaborators
London School of Hygiene and Tropical Medicine, Guy's and St Thomas' NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT04039854
Brief Title
Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery
Acronym
COPIA
Official Title
Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery - a Randomised Controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
November 30, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
Collaborators
London School of Hygiene and Tropical Medicine, Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this research proposal is to find out whether comparing the two different anaesthetic maintenance techniques (Propofol vs volatile anaesthetics) in adult patients undergoing heart surgery is practical for the anaesthetist treating the patients and whether it is feasible for the research team to recruit patients and follow them up after the operation.
Detailed Description
All patients undergoing heart bypass surgery are given anaesthetics during the operation. There are two types of anaesthetic commonly given to patients undergoing heart bypass surgery. Propofol is an anaesthetic that is delivered into the patient's vein. Other anaesthetics which are inhaled include Isoflurane, Sevoflurane and Desflurane and these are called volatile anaesthetics. Preliminary studies over the past ten years suggests that maintenance of general anaesthesia using only volatile anaesthetics has the potential to improve health outcomes after bypass surgery, when compared with propofol. Volatile anaesthetics have been shown to protect the heart, the kidneys and the brain, however results of studies have been inconclusive. Currently both volatile anaesthetics and propofol are used equally in clinical practice in the UK.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Cardiovascular Diseases
Keywords
Anaesthesia, Coronary Artery Bypass Surgery, Cardioprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Volatile anaesthetics arm
Arm Type
Active Comparator
Arm Description
Patients randomised to receive volatile anaesthetics will receive either isoflurane, sevoflurane or desflurane during the surgical procedure.
Arm Title
Propofol anaesthetics arm
Arm Type
Active Comparator
Arm Description
Patients randomised to receive propofol will not receive any volatile anaesthetics during the surgical procedure.
Intervention Type
Drug
Intervention Name(s)
Isoflurane, Sevoflurane or Desflurane
Intervention Description
The volatile anaesthetic agent will be administered via inhalation, i.e. ventilation through alveolar membrane in lungs) during the maintenance of anaesthesia. During CPB the volatile anaesthetic agent will be administered through the oxygenator oxygen inflow of the CPB machine. The maintenance dose of the volatile anaesthetic agent will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia and blood pressure. The administration of the volatile anaesthetic agent will be started after induction of anaesthesia and it will be ended at the end of surgery, before the patient is transferred to the CCU.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Patients will receive propofol only during the surgical procedure. The maintenance dose of the propofol infusion will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia (titrated to a depth of anaesthesia with BIS 30-60) and mean arterial pressure (MAP) of 50-80mmHg by the treating anaesthetist.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
To identify whether it is feasible to recruit up to 50 patients across 2 tertiary cardiac surgery centres within approximately 10 months.
Time Frame
Collected over the recruitment period of 10 months
Title
To identify barriers to recruitment.
Description
This data will be completed on a screening log.
Time Frame
Collected over the recruitment period of 10 months
Secondary Outcome Measure Information:
Title
Feasibility of maintaining follow-up rates of over 95%
Description
This data will be gathered in the trial database.
Time Frame
Collected over the recruitment period of 10 months
Title
Assessment of effectiveness of patient identification and screening processes
Description
To record the number of patients screened and potentially eligible for the trial at the two tertiary cardiac surgery centres within a period of 10 months. This data will be gathered on the screening log.
Time Frame
Collected over the recruitment period of 10 months
Title
To investigate whether it is feasible to recruit at least 10% of all potentially eligible patients at the two tertiary cardiac surgery centres within a period of 10 months.
Description
This data will be gathered on screening logs and in the randomisation system.
Time Frame
Collected over the recruitment period of 10 months
Title
To investigate whether it is feasible to maintain routine data collection and follow up rates greater than 90% over the trial period.
Description
This data will be gathered in the randomisation site and trial database.
Time Frame
Collected over the full trial period of 24 months
Title
To investigate whether it is feasible to achieve 95% data collection of Low Cardiac Output Syndrome for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Collected over the full trial period of 24 months
Title
To investigate whether it is feasible to achieve 95% data collection of Myocardial injury, assessed by ischaemic serum markers: hsTnT, MyC, for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Preop, 6 hrs after arrival in CCU, and postop day 1 and 2. Collected over the full trial period of 24 months
Title
To investigate whether it is feasible to achieve 90% data collection of MACCE (stroke, non-fatal myocardial infarction, death from any cause) for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of Cardiac related mortality at 30 days for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of Postoperative in hospital atrial fibrillation requiring treatment for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of Acute Kidney Injury (according to Kidney Disease: Improving Global Outcomes guidelines) for the full trial over the trial period.
Description
AKI will be confirmed by a 1.5 - 1.9 increase of serum creatinine from baseline or an absolute value rise of creatine greater than 0.3mg/dl (27mmol/L) from baseline. This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of In-hospital postoperative delirium (assessed by the confusion assessment method) for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of Respiratory complications needing prolonged ventilation (>24 hours) for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of Length of stay in the critical care unit (CCU) for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of Length of hospital stay for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of WHO Disability Assessment Schedule (WHODAS) for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days post op.
Title
To investigate whether it is feasible to achieve 90% data collection of Quality of Life Questionnaire (Euroqol, EQ-5D-5L) for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at Baseline and 30 days postoperative
Title
To investigate whether it is feasible to achieve 90% data collection of Days alive and at home for the full trial over the trial period.
Description
This data will be gathered in the trial database.
Time Frame
Data collected at 30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients (male and female) aged 18 years and above Written informed consent to participate Patients undergoing Coronary Artery Bypass Graft (CABG) surgery on Cardiopulmonary bypass (CPB) with or without valve surgery Additive European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 5 or higher Exclusion Criteria: Pregnant or lactating women Allergy to propofol Previous diagnosis or suspected malignant hyperthermia Patients with a known sensitivity to any of the IMPs or other halogenated anaesthetics Concomitant therapy with glibenclamide or nicorandil (medications that may interfere with preconditioning) Inclusion in another clinical trial of an investigational medicinal product within the last 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberley Potter
Phone
02079272505
Ext
2505
Email
kimberley.potter@LSHTM.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Evans
Phone
02072972665
Ext
2665
Email
richard.evans@LSHTM.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Gudrun Kunst
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Thomas' Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin John
First Name & Middle Initial & Last Name & Degree
Martin John
Facility Name
Kings College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gudrun Kunst
First Name & Middle Initial & Last Name & Degree
Gudrun Kunst

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymous participant data may be shared with other researchers

Learn more about this trial

Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery

We'll reach out to this number within 24 hrs