Enhanced Recovery After SurgeryKAMAYNCT06713096
Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
A study testing Tempos Certos protocol in people with Enhanced Recovery After Surgery and Quality Improvement, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This randomized and prospective trial aims to evaluate the implementation of a rapid recovery protocol for coronary artery bypass grafting (CABG) in a hospital serving patients from the Brazilian Unified Health System (Sistema Único de Saúde - SUS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Enhanced Recovery After Surgery, Quality Improvement
- What is being tested?
- Tempos Certos protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Nov 2021to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patients (>18 years old)
- Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status
- Signed informed consent form (ICF)
Who cannot join
- Emergency patients
- Severe ventricular dysfunction (ejection fraction <30%)
- Renal impairment (creatinine clearance <30 mL/min)
- Atrial fibrillation or need for oral anticoagulation
- Moderate-to-severe anemia (hematocrit <32%)
- STS risk score >4%
- Patient and/or family disagreement with the protocol
- Failure to sign the informed consent form
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo
São Paulo, São Paulo, 5403000
Elaine Lagonegro, BSC, (11) 2661-5000, gestaodeprojetos@incor.usp.br
About this study
Official title: Prospective and Randomized Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
This randomized and prospective trial aims to evaluate the implementation of a rapid recovery protocol for coronary artery bypass grafting (CABG) in a hospital serving patients from the Brazilian Unified Health System (Sistema Único de Saúde - SUS). The study will compare outcomes between two groups: patients receiving care under the rapid recovery protocol and those following the standard institutional care.
Primary Objective:
Read more
Compare postoperative hospital stay between the rapid recovery group and the usual care group.
Secondary Objectives:
Assess morbidity and mortality between both groups.
Evaluate patient satisfaction using validated tools.
Analyze incremental costs associated with both approaches.
Assess healthcare teams' learning progression regarding the protocol (Kirkpatrick method).
Evaluate adherence to rapid recovery protocol metrics by healthcare teams.
Measure changes in patient safety culture among healthcare professionals.
Hypothesis:
The null hypothesis assumes no difference in hospital stay between the two groups. The alternative hypothesis suggests that the rapid recovery protocol will reduce hospital stay compared to the standard care. Previous findings from Mejia et al. (2022) indicated a 40% reduction in postoperative hospital stay (from 13 to 7.8 days) for cardiac surgery patients under a rapid recovery protocol at the Heart Institute (InCor HCFMUSP).
This trial will provide critical insights into the applicability of enhanced recovery after surgery (ERAS) principles in cardiac surgery within the context of public healthcare, aiming to improve outcomes and optimize resource use.
- Being tested
- Tempos Certos protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tempos Certos protocolBehavioural
Improve the enhanced recovery by using the Tempos Certos Protocol by the multiprofissional team , using interventions known by science and recommended by scientists.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Not described |
| Interventional care | Active comparator | Not described Receives: Behavioral: Tempos Certos protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hospital stay
Count of time between admission to the intensive care unit and hospital discharge (in hours and days).
Measured: From admission to the intensive care unit until hospital discharge (an average of 14 days of leght of hospital stay)
Secondary outcomes (5)
Number of participants with cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, or death within 30 days after surgery (morbimortality)
Incidence of key morbidities and mortality, including cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, and death.
Measured: Hospital stay to 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
Patient-reported Patient-reported quality of life (SF-36)
Quality of life assessed by SF-36 survey before surgery and 30 days after hospital discharge. Scores range from 0 to 100, with higher scores indicating better quality of life.
Measured: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
Patient-reported Anxiety and depression (HADS)
Assessment of anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Scores range from 0 to 21 for both anxiety and depression subscales, with higher scores indicating greater levels of anxiety or depression.
Measured: Intervention group: Before surgery, at hospital discharge, and 30 days after hospital discharge. Control group: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
Patient experience (HCAHPS)
Assessment of patient experience using the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey.
Measured: Between 3 and 30 days after hospital discharge (an average of 14 days of leght of hospital stay).
Incremental Costs Assessed Using Micro-Costing Analysis
Incremental costs assessed through a detailed micro-costing analysis of preoperative, intraoperative, and postoperative phases. Costs will include hospital stay (ward and intensive care unit), multiprofessional care, medications (including blood transfusion), surgical room costs (surgery time and equipment), operational equipment, consumables, imaging exams, and medical supplies. Costs associated with readmissions within 30 days after discharge will also be included.
Measured: From hospital admission through the postoperative period, including readmissions up to 30 days after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start25 Nov 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabrielle B Borgomoni, bsc, PhD student, Principal investigator, Instituto do coração
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713096
- Sponsor's protocol ID
- 528421059
- Other IDs
- 50781921600000068
- Acronym
- KAMAY
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2023
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Randomized Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT06713096
- Acronym / sponsor ID
- KAMAY / 528421059
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Dec 2024 (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.
This randomized and prospective trial aims to evaluate the implementation of a rapid recovery protocol for coronary artery bypass grafting (CABG) in a hospital serving patients from the Brazilian Unified Health System (Sistema Único de Saúde - SUS). The study will compare outcomes between two groups: patients receiving care under the rapid recovery protocol and those following the standard institutional care.
Primary Objective:
Compare postoperative hospital stay between the rapid recovery group and the usual care group.
Secondary Objectives:
Assess morbidity and mortality between both groups.
Evaluate patient satisfaction using validated tools.
Analyze incremental costs associated with both approaches.
Assess healthcare teams' learning progression regarding the protocol (Kirkpatrick method).
Evaluate adherence to rapid recovery protocol metrics by healthcare teams.
Measure changes in patient safety culture among healthcare professionals.
Hypothesis:
The null hypothesis assumes no difference in hospital stay between the two groups. The alternative hypothesis suggests that the rapid recovery protocol will reduce hospital stay compared to the standard care. Previous findings from Mejia et al. (2022) indicated a 40% reduction in postoperative hospital stay (from 13 to 7.8 days) for cardiac surgery patients under a rapid recovery protocol at the Heart Institute (InCor HCFMUSP).
This trial will provide critical insights into the applicability of enhanced recovery after surgery (ERAS) principles in cardiac surgery within the context of public healthcare, aiming to improve outcomes and optimize resource use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | – |
| Interventional care | Active comparator | Behavioral: Tempos Certos protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (>18 years old)
- Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status
- Signed informed consent form (ICF)
Key exclusion criteria (8 listed)
- Emergency patients
- Severe ventricular dysfunction (ejection fraction <30%)
- Renal impairment (creatinine clearance <30 mL/min)
- Atrial fibrillation or need for oral anticoagulation
- Moderate-to-severe anemia (hematocrit <32%)
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 |
|---|---|---|
| Tempos Certos protocolImprove the enhanced recovery by using the Tempos Certos Protocol by the multiprofissional team , using interventions known by science and recommended by scientists. | Behavioural | Interventional care |
Primary outcome
Postoperative hospital stay
Time frame: From admission to the intensive care unit until hospital discharge (an average of 14 days of leght of hospital stay)
Count of time between admission to the intensive care unit and hospital discharge (in hours and days).
5 secondary outcomes
Number of participants with cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, renal failure, or death within 30 days after surgery (morbimortality)
Time frame: Hospital stay to 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
Patient-reported Patient-reported quality of life (SF-36)
Time frame: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
Patient-reported Anxiety and depression (HADS)
Time frame: Intervention group: Before surgery, at hospital discharge, and 30 days after hospital discharge. Control group: Before surgery and 30 days after hospital discharge (an average of 14 days of leght of hospital stay)
Patient experience (HCAHPS)
Time frame: Between 3 and 30 days after hospital discharge (an average of 14 days of leght of hospital stay).
Incremental Costs Assessed Using Micro-Costing Analysis
Time frame: From hospital admission through the postoperative period, including readmissions up to 30 days after discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
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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.
Gabrielle B Borgomoni, bsc, PhD student principal investigator
Instituto do coração
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tempos Certos protocol in people with Enhanced Recovery After Surgery and Quality Improvement, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 8 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: looking for participants now, as of the sponsor's last update on 3 Dec 2024. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar A V Mejia, md, PhD (555+(11) 2661-5014, omarvmejia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hospital stay (time frame: From admission to the intensive care unit until hospital discharge (an average of 14 days of leght of hospital stay)). 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 3 Dec 2024.