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Enhanced Recovery After Cardiac Surgery (ERAS)

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ClinicalTrials.gov Identifier: NCT03859102
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : September 27, 2019
Sponsor:
Collaborator:
Medela AG
Information provided by (Responsible Party):
Dr Jim Coates, James Cook University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Cardiac Surgery Coronary Artery Disease Aortic Valve Disease Mitral Valve Disease Tricuspid Valve Disease Aortic Root Dilatation 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 Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential prospective cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Delivering Enhanced Recovery After Cardiac Surgery
Actual Study Start Date : December 17, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : November 29, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
No Intervention: ERAS Control/non-ERAS group
Standard usual care after cardiac surgery.
Experimental: ERAS group

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.

Dietary Supplement: Pre-operative Carbohydrate PreLoad drink
Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery.

Drug: Oral Gabapentin pre-op
One dose of Gabapentin pre-operatively, 300mg orally.

Drug: Oral Lansoprazole pre-op
One dose of Lansoprazole pre-operatively, 30mg orally.

Drug: Intravenous Paracetamol intra-operatively
One dose of Paracetamol intra-operatively, 1gram intravenous infusion.

Drug: Intravenous Dexamethasone intra-operatively
One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.

Drug: Intravenous Ondansetron intra-operatively
One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous

Drug: Infiltration of surgical wounds with local anaesthetic
Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.

Drug: Intravenous Magnesium intra-operatively
One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.

Drug: Post-operative Gabapentin analgesia
Post-operative oral Gabapentin 300mg, three times daily as an analgesic.

Drug: Post-operative oral Paracetamol analgesia
Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.

Drug: Post-operative Ondansetron anti-emesis
Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required.

Procedure: Early extubation
Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe.

Procedure: Early mobilisation/physiotherapy
Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively.

Other: Encourage early oral food intake
Patients will be encouraged to start eating as soon as possible post-operatively




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Time to extubation [ Time Frame: 0-24hours ]
    Time taken until patient extubated (ETT) post op (in minutes)

  2. Time to mobilisation [ Time Frame: 0-48hours ]
    First mobilisation with nurse/physiotherapist post-op (in minutes)

  3. Time to oral diet [ Time Frame: 0-48hours ]
    Time until patient first eats post-op (in minutes)

  4. Post-op pain [ Time Frame: 6hours ]
    Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)

  5. Post-op pain [ Time Frame: 12hours ]
    Pain scores at 12hours, Numeric scale 0 (no pain) - 10 (severe pain)

  6. Post-op pain [ Time Frame: 24hours ]
    Pain scores at 24hours, Numeric scale 0 (no pain) - 10 (severe pain)

  7. Quality of Recovery [ Time Frame: 6 weeks post surgery ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Aged 18 years or under
  • Deemed not suitable for ERAS by Surgeon and/or Anaesthetist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859102


Contacts
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Contact: Jim C Coates, MBBS 01642854630 james.coates1@nhs.net
Contact: Adrian Mellor, MBBS 01642850850 adrian.mellor@nhs.net

Locations
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United Kingdom
James Cook University Hospital Recruiting
Middlesbrough, Teeside, United Kingdom, TS4 3BW
Contact: Jim C Coates, MBBS    01642854630    james.coates1@nhs.net   
Principal Investigator: Jim C Coates, MBBS         
Sub-Investigator: Adrian Mellor, MBBS         
Sub-Investigator: Sarah Round, MBBS         
Sub-Investigator: Jonathan Brand, MBBS         
Sub-Investigator: Enoch Akuowah, MBBS         
Sponsors and Collaborators
James Cook University Hospital
Medela AG
Investigators
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Principal Investigator: Jim C Coates, MBBS James Cook University Hospital

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Responsible Party: Dr Jim Coates, Clinical Research Fellow in Cardiothoracic Anaesthesia, James Cook University Hospital
ClinicalTrials.gov Identifier: NCT03859102     History of Changes
Other Study ID Numbers: IRAS242926
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Jim Coates, James Cook University Hospital:
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
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Acetaminophen
Dexamethasone
Dexamethasone acetate
Gabapentin
Ondansetron
Anesthetics
Anesthetics, Local
Lansoprazole
Dexlansoprazole
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors