Coronary Heart DiseasePhase 4COPIANCT04039854
Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery
A Phase 4 study testing Isoflurane, Sevoflurane or Desflurane and Propofol in people with Coronary Heart Disease and Cardiovascular Diseases, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Cardiovascular Diseases
- What is being tested?
- Isoflurane, Sevoflurane or Desflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Nov 2019to 31 Jan 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
St Thomas' Hospital
London, SE1 7EH
Martin John
Martin John
- Recruiting
Kings College Hospital NHS Foundation Trust
London, SE5 9RS
Gudrun Kunst
Gudrun Kunst
About this study
Official title: Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery - a Randomised Controlled Feasibility Trial
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.
Read the 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.
- Conditions
- Coronary Heart Disease, Cardiovascular Diseases
- Being tested
- Isoflurane, Sevoflurane or Desflurane, Propofol
- Keywords
- Anaesthesia, Coronary Artery Bypass Surgery, Cardioprotection
- Medical subject headings
- Coronary Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoflurane, Sevoflurane or DesfluraneDrug
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.
PropofolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Volatile anaesthetics arm | Active comparator | Patients randomised to receive volatile anaesthetics will receive either isoflurane, sevoflurane or desflurane during the surgical procedure. Receives: Drug: Isoflurane, Sevoflurane or Desflurane |
| Propofol anaesthetics arm | Active comparator | Patients randomised to receive propofol will not receive any volatile anaesthetics during the surgical procedure. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
To identify whether it is feasible to recruit up to 50 patients across 2 tertiary cardiac surgery centres within approximately 10 months.
Measured: Collected over the recruitment period of 10 months
To identify barriers to recruitment.
This data will be completed on a screening log.
Measured: Collected over the recruitment period of 10 months
Secondary outcomes (17)
Feasibility of maintaining follow-up rates of over 95%
This data will be gathered in the trial database.
Measured: Collected over the recruitment period of 10 months
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.
Measured: Collected over the recruitment period of 10 months
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.
Measured: Collected over the recruitment period of 10 months
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.
Measured: Collected over the full trial period of 24 months
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.
Measured: Collected over the full trial period of 24 months
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.
Measured: Preop, 6 hrs after arrival in CCU, and postop day 1 and 2. Collected over the full trial period of 24 months
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at 30 days post op.
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.
Measured: Data collected at Baseline and 30 days postoperative
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.
Measured: Data collected at 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start20 Nov 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Dr Gudrun Kunst, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039854
- Sponsor's protocol ID
- KCH-PRO:19/001
- Other IDs
- 2019-000171-16, 216646, 2019
- Acronym
- COPIA
- Status last verified
- Feb 2021
- First submitted
- 7 Jun 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous participant data may be shared with other researchers
Publications
Milne B, John M, Evans R, Robertson S, O Scanaill P, Murphy GJ, Landoni G, Marber M, Clayton T, Kunst G. Comparison between propofol and total inhalational anaesthesia on cardiovascular outcomes following on-pump cardiac surgery in higher-risk patients: a randomised controlled pilot and feasibility study. Open Heart. 2024 May 9;11(1):e002630. doi: 10.1136/openhrt-2024-002630.
PubMed 38724266
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery - a Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT04039854
- Acronym / sponsor ID
- COPIA / KCH-PRO:19/001
- Conditions
- Coronary Heart Disease, Cardiovascular Diseases
- Keywords
- Anaesthesia, Coronary Artery Bypass Surgery, Cardioprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Guy's and St Thomas' NHS Foundation Trust
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Volatile anaesthetics arm | Active comparator | Drug: Isoflurane, Sevoflurane or DesfluranePatients randomised to receive volatile anaesthetics will receive either isoflurane, sevoflurane or desflurane during the surgical procedure. |
| Propofol anaesthetics arm | Active comparator | Drug: PropofolPatients randomised to receive propofol will not receive any volatile anaesthetics during the surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isoflurane, Sevoflurane or DesfluraneThe 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. | Drug | Volatile anaesthetics arm |
| PropofolPatients 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. | Drug | Propofol anaesthetics arm |
Primary outcome
Recruitment rate
Time frame: Collected over the recruitment period of 10 months
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.
Time frame: Collected over the recruitment period of 10 months
This data will be completed on a screening log.
17 secondary outcomes
Feasibility of maintaining follow-up rates of over 95%
Time frame: Collected over the recruitment period of 10 months
Assessment of effectiveness of patient identification and screening processes
Time frame: Collected over the recruitment period of 10 months
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.
Time frame: Collected over the recruitment period of 10 months
To investigate whether it is feasible to maintain routine data collection and follow up rates greater than 90% over the trial period.
Time frame: Collected over the full trial period of 24 months
To investigate whether it is feasible to achieve 95% data collection of Low Cardiac Output Syndrome for the full trial over the trial period.
Time frame: Collected over the full trial period of 24 months
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.
Time frame: Preop, 6 hrs after arrival in CCU, and postop day 1 and 2. Collected over the full trial period of 24 months
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.
Time frame: Data collected at 30 days post op.
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.
Time frame: Data collected at 30 days post op.
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.
Time frame: Data collected at 30 days post op.
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.
Time frame: Data collected at 30 days post op.
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.
Time frame: Data collected at 30 days post op.
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.
Time frame: Data collected at 30 days post op.
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.
Time frame: Data collected at 30 days post op.
To investigate whether it is feasible to achieve 90% data collection of Length of hospital stay for the full trial over the trial period.
Time frame: Data collected at 30 days post op.
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.
Time frame: Data collected at 30 days post op.
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.
Time frame: Data collected at Baseline and 30 days postoperative
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.
Time frame: Data collected at 30 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Derived from this study: PubMed 38724266Milne B, John M, Evans R, Robertson S, O Scanaill P, Murphy GJ, Landoni G, Marber M, Clayton T, Kunst G. Comparison between propofol and total inhalational anaesthesia on cardiovascular outcomes following on-pump cardiac surgery in higher-risk patients: a randomised controlled pilot and feasibility study. Open Heart. 2024 May 9;11(1):e002630. doi: 10.1136/openhrt-2024-002630.
- Individual participant dataSharing planned: Yes. Anonymous participant data may be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Gudrun Kunst principal investigator
King's College Hospital NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Isoflurane, Sevoflurane or Desflurane and Propofol in people with Coronary Heart Disease and Cardiovascular Diseases, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberley Potter (02079272505 ext. 2505, kimberley.potter@LSHTM.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: Collected over the recruitment period of 10 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04039854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.