Cardiac SurgeryERASNCT03859102
Enhanced Recovery After Cardiac Surgery
A study testing Pre-operative Carbohydrate PreLoad drink, Oral Gabapentin pre-op and Oral Lansoprazole pre-op in people with Cardiac Surgery and Coronary Artery Disease, run by James Cook University Hospital at 1 site in United Kingdom.
Trial summary
Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Coronary Artery Disease, Aortic Valve Disease
- What is being tested?
- Pre-operative Carbohydrate PreLoad drink, Oral Gabapentin pre-op and Oral Lansoprazole pre-op
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Dec 2018to 29 Nov 2019
- Phase
- Interventional
- 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
- Having Cardiac Surgery
- Aged 18 years or older at the time of consent
- Deemed appropriate for ERAS by Surgeon and Anaesthetist
- Able and willing to provide written informed consent
Who cannot join
- Aged 18 years or under
- Deemed not suitable for ERAS by Surgeon and/or Anaesthetist
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
James Cook University Hospital
Middlesbrough, Teeside, TS4 3BW
Jim C Coates, MBBS, 01642854630, james.coates1@nhs.net
Jim C Coates, MBBS
About this study
Official title: Feasibility of Delivering Enhanced Recovery After Cardiac Surgery
Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society.
The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.
Read the detailed description
Why? Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society. These protocols have been demonstrated as safe, though have yet to make it into mainstream practice in the UK. The use of ERPs in Cardiac Surgery has the potential to greatly improve the patient journey and hospital efficiency.
What? The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.
Who? All adult patients over the age of 18 years and listed for cardiac surgery will be considered for inclusion in this study.
Where? The study population will be comprised of patients undergoing cardiac surgery at the James Cook University Hospital in Middlesbrough.
How? Study duration will be 6 months, with 80 patients (comprising a control and intervention group)
- Conditions
- Cardiac Surgery, Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease, Aortic Root Dilatation
- Being tested
- Pre-operative Carbohydrate PreLoad drink, Oral Gabapentin pre-op, Oral Lansoprazole pre-op, Intravenous Paracetamol intra-operatively, Intravenous Dexamethasone intra-operatively
- Keywords
- Enhanced recovery after Surgery, ERAS, Enhanced Recovery after Cardiac Surgery, Cardiac Surgery, Coronary Artery Bypass graft, Aortic Valve Surgery, Mitral Valve Surgery, Aortic Root Surgery
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative Carbohydrate PreLoad drinkDietary supplement
Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery.
Oral Gabapentin pre-opDrug
One dose of Gabapentin pre-operatively, 300mg orally.
Oral Lansoprazole pre-opDrug
One dose of Lansoprazole pre-operatively, 30mg orally.
Intravenous Paracetamol intra-operativelyDrug
One dose of Paracetamol intra-operatively, 1gram intravenous infusion.
Intravenous Dexamethasone intra-operativelyDrug
One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.
Intravenous Ondansetron intra-operativelyDrug
One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous
Infiltration of surgical wounds with local anaestheticDrug
Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.
Intravenous Magnesium intra-operativelyDrug
One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.
Post-operative Gabapentin analgesiaDrug
Post-operative oral Gabapentin 300mg, three times daily as an analgesic.
Post-operative oral Paracetamol analgesiaDrug
Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.
Post-operative Ondansetron anti-emesisDrug
Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required.
Early extubationProcedure or surgery
Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe.
Early mobilisation/physiotherapyProcedure or surgery
Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively.
Encourage early oral food intakeOther
Patients will be encouraged to start eating as soon as possible post-operatively
| Study group | Role | What they receive |
|---|---|---|
| ERAS Control/non-ERAS group | No intervention | Standard usual care after cardiac surgery. |
| ERAS group | Experimental | Enhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin.
Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds.
Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge. Receives: Dietary Supplement: Pre-operative Carbohydrate PreLoad drink; Drug: Oral Gabapentin pre-op; Drug: Oral Lansoprazole pre-op; Drug: Intravenous Paracetamol intra-operatively; Drug: Intravenous Dexamethasone intra-operatively; Drug: Intravenous Ondansetron intra-operatively; Drug: Infiltration of surgical wounds with local anaesthetic; Drug: Intravenous Magnesium intra-operatively; Drug: Post-operative Gabapentin analgesia; Drug: Post-operative oral Paracetamol analgesia; Drug: Post-operative Ondansetron anti-emesis; Procedure: Early extubation; Procedure: Early mobilisation/physiotherapy; Other: Encourage early oral food intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERAS bundle compliance in the first 48hours post-op
Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 6 out of 10)
Measured: 48hours post op
Secondary outcomes (7)
Time to extubation
Time taken until patient extubated (ETT) post op (in minutes)
Measured: 0-24hours
Time to mobilisation
First mobilisation with nurse/physiotherapist post-op (in minutes)
Measured: 0-48hours
Time to oral diet
Time until patient first eats post-op (in minutes)
Measured: 0-48hours
Post-op pain
Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)
Measured: 6hours
Post-op pain
Pain scores at 12hours, Numeric scale 0 (no pain) - 10 (severe pain)
Measured: 12hours
Post-op pain
Pain scores at 24hours, Numeric scale 0 (no pain) - 10 (severe pain)
Measured: 24hours
Quality of Recovery
Quantification of patient quality of recovery. Using Q-o-R 15 Scale internationally validated scale. This allows the patient to report on a numerical scale from 0 (not at all) to 10 (all of the time); the patients scores on aspects of recovery such as pain at rest, pain on movement, quality of sleep, presence of nausea and vomiting, feeling supported by medical staff.
Measured: 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start17 Dec 2018
- Primary completion1 Oct 2019 (estimated)
- Study completion29 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential prospective cohort study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James Cook University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medela AG
- Responsible party
- Principal investigator, Dr Jim Coates, James Cook University Hospital
- Investigators
- Jim C Coates, MBBS, Principal investigator, James Cook University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03859102
- Sponsor's protocol ID
- IRAS242926
- Acronym
- ERAS
- Status last verified
- Sep 2019
- First submitted
- 28 Dec 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Delivering Enhanced Recovery After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03859102
- Acronym / sponsor ID
- ERAS / IRAS242926
- Conditions
- Cardiac Surgery, Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease, Tricuspid Valve Disease, Aortic Root Dilatation
- Keywords
- Enhanced recovery after Surgery, ERAS, Enhanced Recovery after Cardiac Surgery, Cardiac Surgery, Coronary Artery Bypass graft, Aortic Valve Surgery, Mitral Valve Surgery, Aortic Root Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- James Cook University HospitalUniversity, hospital or other
- Collaborators
- Medela AG
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 29 Nov 2019 (estimated)
- First posted
- 1 Mar 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.
Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society.
The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.
Detailed description
Why? Enhanced Recovery Protocols (ERPs or bundles) have been established in many surgical specialties (such as colon cancer and orthopaedic joint surgeries) for several years in hospitals worldwide. The principles of Enhanced Recovery Protocols are those of early mobilization and restoration of normal function as soon as possible after surgery. These principles are achieved by use of alternate pain control regimens and removing invasive lines and drains as soon as possible. The benefits of ERPs are improved patient experience, earlier return to normal function and reduced length of stay. Enhanced recovery protocols for cardiac surgery have been published by the Enhanced Recovery After Cardiac Surgery Society. These protocols have been demonstrated as safe, though have yet to make it into mainstream practice in the UK. The use of ERPs in Cardiac Surgery has the potential to greatly improve the patient journey and hospital efficiency.
What? The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.
Who? All adult patients over the age of 18 years and listed for cardiac surgery will be considered for inclusion in this study.
Where? The study population will be comprised of patients undergoing cardiac surgery at the James Cook University Hospital in Middlesbrough.
How? Study duration will be 6 months, with 80 patients (comprising a control and intervention group)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| ERAS Control/non-ERAS group | No intervention | –Standard usual care after cardiac surgery. |
| ERAS group | Experimental | Dietary Supplement: Pre-operative Carbohydrate PreLoad drink, Drug: Oral Gabapentin pre-op, Drug: Oral Lansoprazole pre-op, Drug: Intravenous Paracetamol intra-operatively, Drug: Intravenous Dexamethasone intra-operatively, Drug: Intravenous Ondansetron intra-operatively, Drug: Infiltration of surgical wounds with local anaesthetic, Drug: Intravenous Magnesium intra-operatively, Drug: Post-operative Gabapentin analgesia, Drug: Post-operative oral Paracetamol analgesia, Drug: Post-operative Ondansetron anti-emesis, Procedure: Early extubation, Procedure: Early mobilisation/physiotherapy, Other: Encourage early oral food intakeEnhanced Recovery After Cardiac Surgery. Pre-op carbohydrate drink, Lansoprazole and Gabapentin. Intra-operative: IV Paracetamol, Dexamethasone, Ondansetron, Local Anaesthetic to wounds. Post-op: Gabapentin PO, Paracetamol IV then PO, Ondansetron IV for 24hrs. Opiate sparing. Early extubation, early mobilisation, early removal of invasive devices. Early discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having Cardiac Surgery
- Aged 18 years or older at the time of consent
- Deemed appropriate for ERAS by Surgeon and Anaesthetist
- Able and willing to provide written informed consent
Key exclusion criteria (2 listed)
- Aged 18 years or under
- Deemed not suitable for ERAS by Surgeon and/or Anaesthetist
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 |
|---|---|---|
| Pre-operative Carbohydrate PreLoad drinkPre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery. | Dietary supplement | ERAS group |
| Oral Gabapentin pre-opOne dose of Gabapentin pre-operatively, 300mg orally. | Drug | ERAS group |
| Oral Lansoprazole pre-opOne dose of Lansoprazole pre-operatively, 30mg orally. | Drug | ERAS group |
| Intravenous Paracetamol intra-operativelyOne dose of Paracetamol intra-operatively, 1gram intravenous infusion. | Drug | ERAS group |
| Intravenous Dexamethasone intra-operativelyOne dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous. | Drug | ERAS group |
| Intravenous Ondansetron intra-operativelyOne dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous | Drug | ERAS group |
| Infiltration of surgical wounds with local anaestheticInfiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg. | Drug | ERAS group |
| Intravenous Magnesium intra-operativelyOne infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes. | Drug | ERAS group |
| Post-operative Gabapentin analgesiaPost-operative oral Gabapentin 300mg, three times daily as an analgesic. | Drug | ERAS group |
| Post-operative oral Paracetamol analgesiaPost-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily. | Drug | ERAS group |
| Post-operative Ondansetron anti-emesisIntravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required. | Drug | ERAS group |
| Early extubationRemoval of the endotracheal tube in the Intensive Care Unit as soon as is safe. | Procedure or surgery | ERAS group |
| Early mobilisation/physiotherapyMobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively. | Procedure or surgery | ERAS group |
| Encourage early oral food intakePatients will be encouraged to start eating as soon as possible post-operatively | Other | ERAS group |
Primary outcome
ERAS bundle compliance in the first 48hours post-op
Time frame: 48hours post op
Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 6 out of 10)
7 secondary outcomes
Time to extubation
Time frame: 0-24hours
Time to mobilisation
Time frame: 0-48hours
Time to oral diet
Time frame: 0-48hours
Post-op pain
Time frame: 6hours
Post-op pain
Time frame: 12hours
Post-op pain
Time frame: 24hours
Quality of Recovery
Time frame: 6 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Jim C Coates, MBBS principal investigator
James Cook University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-operative Carbohydrate PreLoad drink, Oral Gabapentin pre-op and Oral Lansoprazole pre-op in people with Cardiac Surgery and Coronary Artery Disease, run by James Cook University Hospital at 1 site 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 2 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 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 Jim C Coates, MBBS (01642854630, james.coates1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERAS bundle compliance in the first 48hours post-op (time frame: 48hours post op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2019.