Coronary Artery DiseaseNCT03956420
Enhanced Recovery After Surgery (ERAS) in Coronary Artery Bypass Graft / Off Pump Coronary Artery Bypass (CABG/OPCAB)
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Silesian University of Medicine at 1 site in Poland.
Trial summary
It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery. Elements of the ERAS strategy will be tested in this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease, Coronary Stenosis
- What is being tested?
- Premedication visit, Preoperative period and Postoperative period
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 3 May 2019to May 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who meet the inclusion criteria will be eligible for the study. The perioperative period and anaesthesia will be supervised by anaesthesiologists trained to carry out the study. The study group will include 50 patients. The results obtained in the study group will be compared with the results of the control group. The control group will consist of patients treated during the study in accordance with the current standards used in the Department.
Who may be able to join
- CABG/OPCAB (Coronary Artery Bypass Surgery/Off Pump Coronary Bypass Surgery).
- Left ventricular ejection fraction above 35% (EF ≥ 35%).
- The operation was performed in a planned mode.
Who cannot join
- Haematological diseases and the associated increased risk of bleeding in the early postoperative period. Patients taking anticoagulants until the day of surgery with the exception of aspirin.
- Neurological disorders, stroke with persistent symptoms, dementia.
- Chronic lung disease with hypoxia and the need for regular medication.
- Inability to move independently, disability preventing efficient rehabilitation, prolonged use of painkillers.
- Emergency surgery, reoperation.
- Return to the operating room regardless of the reason (resternotomy).
- Perioperative infarction with circulatory destabilization.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Upper-Silesian Medical Centre of the Silesian Medical University
Katowice, Polska, 40-635
About this study
Official title: ERAS Implementation in Coronary Artery Bypass Surgery
It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery.
Elements of the ERAS strategy will be tested in this study. The elements that prove to be feasible and have a positive effect on the treatment process will be introduced into everyday clinical practice.
In the next stage of the research, we are planning to investigate whether the introduction of the ERAS strategy has had a long-term positive effect on the quality of life after treatment (a survey 1 month and 6 months after leaving the hospital).
Read the detailed description
Evaluation of the impact of implemented elements of the ERAS strategy on the results of surgical treatment of coronary artery disease in the aspect of:
- preoperative preparation (comprehensive information, premedication, hydration),
- haemodynamic stability (discontinuation of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers immediately before surgery), optimal pre- and intraoperative fluid therapy,
- occurrence of respiratory complications (assessment of the duration of mechanical ventilation and passive oxygen therapy),
- demand for painkillers in the postoperative period, after introducing the preemptive strategy,
- incidence of postoperative delirium,
- time to recovery of the normal bowel function (nausea, vomiting),
- possibility of early mobilisation on the first day after surgery,
- patient's satisfaction with treatment assessed on the basis of a survey carried out on the day before leaving the hospital.
- Conditions
- Coronary Artery Disease, Coronary Stenosis
- Being tested
- Premedication visit, Preoperative period, Postoperative period, Intraoperative period
- Keywords
- Coronary Artery Bypass Surgery/Grafting, ERAS
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Premedication visitBehavioural
detailed information about surgery, anaesthesia and postoperative period
Preoperative periodDietary supplement
avoidance of prolonged fasting, intake of fluids with carbohydrates before surgery
Preoperative periodDrug
administration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre
Postoperative periodOther
Fluids 1 ml/kg/h; Discontinuation of propofol at the moment of drainage and cardiovascular system stabilization; Fluids administered orally 2 hours after extubation; Early mobilisation
Intraoperative periodOther
Also called Normothermia
deep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored.
Intraoperative periodDrug
Pyralgin 1 g i.v. after induction of anaesthesia; in patients allergic to Pyralginum, Perfalgan 1 g i.v.
Intraoperative periodDrug
Ketamine 30 mg i.v. after induction of anaesthesia
Intraoperative periodDrug
Sevoflurane 1.5 MAC higher in patients < 60 years old
Intraoperative periodDrug
Propofol infusion in patients at risk of postoperative vomiting (Apfel ≥ 2 points), sevoflurane administration at the moments of strong stimuli from the operating field
Intraoperative periodDrug
Continuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Study group | Implemented ERAS (Early Recovery After Surgery) elements Receives: Behavioral: Premedication visit; Dietary Supplement: Preoperative period; Drug: Preoperative period; Other: Postoperative period; Other: Intraoperative period; Drug: Intraoperative period | |
| Control group | The control group will consist of patients treated during the study in accordance with the current standards used in the Department |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERAS bundle compliance in the first 72 hours post-op
Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 5 out of 10)
Measured: 72 hours post operation
Shorter Length Of Hospitalization (LOH)
Total amount of days spent in hospital
Measured: up to 4 weeks after operation
Secondary outcomes (10)
Preoperative anxiety
Assessment of patient's emotional status according to Anxiety Likert Scale (consisted of five evenly spaced numbers each anchored to a level of anxiety: 1="not at all anxious," 2="a little anxious," 3="moderately anxious," 4="very anxious," 5="extremely anxious)
Measured: on admission to the operating unit
Time to extubation
Time taken until patient extubated post operation (in hours)
Measured: 0 -72 hours
Assessment of postoperative pain
Pain scores at 6hours, Numeric scale 0 (no pain) - 10 (severe pain)
Measured: 0-24 hours
Incidence of postoperative nausea and vomiting
To calculate the PONV Impact Scale score, add the numerical responses to questions 1 and 2. A PONV Impact Scale score of ≥5 defines clinically important PONV (Q1. Have you vomited: 0. No
- Once
- Twice
- Three or more times Q2. Have you experienced a feeling of nausea :0. Not at all
- Sometimes 2. Often or most of the time 3. All of the time)
Measured: At moment 0, 3, 6, 12 and 24 hours after extubation
Time to drink
Time until patient first drinks post extubation (in hours)
Measured: 0-72 hours
Time to eating
Time until patient first eats post extubation (in hours)
Measured: 0-72 hours
Time to bowel movement
Hours elapsed to event
Measured: in hours after extubation, up to 1 week
Incidence of postoperative delirium
Delirium Screening according to Nursing Delirium Screening Scale, Each feature is scored on 0-2 based on severity, with 0=absent, 1=mild, and 2=severe.
Positive Nu-DESC is score ≥2, maximum total score is 10
Measured: in hours after extubation, up to 72 hours
Postoperative complications
Rate measurement
Measured: up to 2 weeks after surgery
Time to mobilisation
First mobilisation with nurse/physiotherapist post-op (in hours)
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start3 May 2019
- Primary completionJan 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silesian University of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewa Kucewicz-Czech, Silesian University of Medicine
- Investigators
- Ewa Kucewicz-Czech, Study chair, Upper-Silesian Medical Centre; DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE WITH CARDIAC MONITORING
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956420
- Sponsor's protocol ID
- KNW/0022/KB1/26/18
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 20 May 2019
- Results posted
- 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 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERAS Implementation in Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT03956420
- Acronym / sponsor ID
- KNW/0022/KB1/26/18
- Conditions
- Coronary Artery Disease, Coronary Stenosis
- Keywords
- Coronary Artery Bypass Surgery/Grafting, ERAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Silesian University of MedicineUniversity, hospital or other
- Study start
- 3 May 2019 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 20 May 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.
It has been assumed that some elements of the ERAS protocol may contribute to the reduction of complications and improve the satisfaction of patients undergoing coronary artery bypass surgery.
Elements of the ERAS strategy will be tested in this study. The elements that prove to be feasible and have a positive effect on the treatment process will be introduced into everyday clinical practice.
In the next stage of the research, we are planning to investigate whether the introduction of the ERAS strategy has had a long-term positive effect on the quality of life after treatment (a survey 1 month and 6 months after leaving the hospital).
Detailed description
Evaluation of the impact of implemented elements of the ERAS strategy on the results of surgical treatment of coronary artery disease in the aspect of:
- preoperative preparation (comprehensive information, premedication, hydration),
- haemodynamic stability (discontinuation of angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers immediately before surgery), optimal pre- and intraoperative fluid therapy,
- occurrence of respiratory complications (assessment of the duration of mechanical ventilation and passive oxygen therapy),
- demand for painkillers in the postoperative period, after introducing the preemptive strategy,
- incidence of postoperative delirium,
- time to recovery of the normal bowel function (nausea, vomiting),
- possibility of early mobilisation on the first day after surgery,
- patient's satisfaction with treatment assessed on the basis of a survey carried out on the day before leaving the hospital.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Behavioral: Premedication visit, Dietary Supplement: Preoperative period, Drug: Preoperative period, Other: Postoperative period, Other: Intraoperative period, Drug: Intraoperative periodImplemented ERAS (Early Recovery After Surgery) elements |
| Control group | – | –The control group will consist of patients treated during the study in accordance with the current standards used in the Department |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who meet the inclusion criteria will be eligible for the study. The perioperative period and anaesthesia will be supervised by anaesthesiologists trained to carry out the study. The study group will include 50 patients. The results obtained in the study group will be compared with the results of the control group. The control group will consist of patients treated during the study in accordance with the current standards used in the Department.
Key inclusion criteria (3 listed)
- CABG/OPCAB (Coronary Artery Bypass Surgery/Off Pump Coronary Bypass Surgery).
- Left ventricular ejection fraction above 35% (EF ≥ 35%).
- The operation was performed in a planned mode.
Key exclusion criteria (7 listed)
- Haematological diseases and the associated increased risk of bleeding in the early postoperative period. Patients taking anticoagulants until the day of surgery with the exception of aspirin.
- Neurological disorders, stroke with persistent symptoms, dementia.
- Chronic lung disease with hypoxia and the need for regular medication.
- Inability to move independently, disability preventing efficient rehabilitation, prolonged use of painkillers.
- Emergency surgery, reoperation.
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 |
|---|---|---|
| Premedication visitdetailed information about surgery, anaesthesia and postoperative period | Behavioural | Study group |
| Preoperative periodavoidance of prolonged fasting, intake of fluids with carbohydrates before surgery | Dietary supplement | Study group |
| Preoperative periodadministration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre | Drug | Study group |
| Postoperative periodFluids 1 ml/kg/h; Discontinuation of propofol at the moment of drainage and cardiovascular system stabilization; Fluids administered orally 2 hours after extubation; Early mobilisation | Other | Study group |
| Intraoperative periodAlso: Normothermiadeep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored. | Other | Study group |
| Intraoperative periodPyralgin 1 g i.v. after induction of anaesthesia; in patients allergic to Pyralginum, Perfalgan 1 g i.v. | Drug | Study group |
| Intraoperative periodKetamine 30 mg i.v. after induction of anaesthesia | Drug | Study group |
| Intraoperative periodSevoflurane 1.5 MAC higher in patients < 60 years old | Drug | Study group |
| Intraoperative periodPropofol infusion in patients at risk of postoperative vomiting (Apfel ≥ 2 points), sevoflurane administration at the moments of strong stimuli from the operating field | Drug | Study group |
| Intraoperative periodContinuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h | Drug | Study group |
Primary outcome
ERAS bundle compliance in the first 72 hours post-op
Time frame: 72 hours post operation
Number of interventions for the ERAS protocol that are delivered to patient (numeric data e.g. 5 out of 10)
Shorter Length Of Hospitalization (LOH)
Time frame: up to 4 weeks after operation
Total amount of days spent in hospital
10 secondary outcomes
Preoperative anxiety
Time frame: on admission to the operating unit
Time to extubation
Time frame: 0 -72 hours
Assessment of postoperative pain
Time frame: 0-24 hours
Incidence of postoperative nausea and vomiting
Time frame: At moment 0, 3, 6, 12 and 24 hours after extubation
Time to drink
Time frame: 0-72 hours
Time to eating
Time frame: 0-72 hours
Time to bowel movement
Time frame: in hours after extubation, up to 1 week
Incidence of postoperative delirium
Time frame: in hours after extubation, up to 72 hours
Postoperative complications
Time frame: up to 2 weeks after surgery
Time to mobilisation
Time frame: 0-72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 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.
Ewa Kucewicz-Czech study chair
Upper-Silesian Medical Centre; DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE WITH CARDIAC MONITORING
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Stenosis, run by Silesian University of Medicine at 1 site in Poland.
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 3 inclusion and 7 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 20 May 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 Poland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERAS bundle compliance in the first 72 hours post-op (time frame: 72 hours post operation). 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?
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 20 May 2019.